A Randomised Controlled Trial of an Online Mindfulness-Based Intervention for Paranoia in a

Non-Clinical Population

Rob Shore

Submitted for the Degree of

Doctor of Psychology(Clinical Psychology)

School of PsychologyFaculty of Arts & Human Sciences

University of SurreyGuildford, SurreyUnited KingdomSeptember 2015

Abstract

Objectives: Paranoia is common in the general population and can impact on health,

emotional well-being and social functioning; therefore effective interventions are needed.

Brief online mindfulness-based interventions (MBIs) have the potential to be an easily

accessible, low cost treatment for non-clinical populations. There is promising evidence for

brief online MBIs for anxiety and depression however at present there is no research

investigating whether they can benefit people with paranoia in the general population.

Therefore the current study explored whether a brief online MBI increased levels of

mindfulness and reduced levels of paranoia in a non-clinical population. The mediating effect

of mindfulness on any changes in paranoia was also investigated.

Method: 110 participants were randomly allocated to either a two week online MBI

involving 10 minutes of daily guided mindfulness practice or to a waitlist control condition.

Measures of mindfulness and paranoia were administered at baseline, post-intervention and

one-week follow-up.

Results: Analysis of the data indicated that there were significant group by time interactions

for levels of paranoia and mindfulness skills. Participants in the MBI group displayed

significantly greater reductions in paranoia and increases in mindfulness when compared to

the waitlist control group. Mediation analysis demonstrated that change in mindfulness skills

mediated the relationship between intervention type and change in levels of paranoia.

Conclusions: This study provides evidence that a brief online MBI can increase mindfulness

skills and significantly reduce levels of paranoia in a non-clinical population. Furthermore,

increases in mindfulness skills from this brief online MBI can mediate reductions in non-

clinical paranoia. The limitations and clinical implications of this study are discussed.

Acknowledgements

I would like to thank my field supervisors Clara Strauss and Lyn Ellett for their in

depth knowledge of mindfulness research and their insight, support and supervision

throughout the research project. I would also like to thank my university supervisor, Kate

Gleeson, for always being there to provide support when needed. I would also like to thank

my fellow trainee Kim Skerrett for developing the intervention website and recruiting

participants in tandem with me. I would like to thank Andrew Barnes for his support with

creating our intervention website and gathering data from it. I would like to thank my clinical

tutors, Nan Holmes and Simon Draycott for their support and guidance on clinical

placements. I would also like to thank my placement supervisors, Louise Harriss, Katy Lee,

Julie Lloyd, Pip Crompton and Damian Dewhurst for their outstanding supervision, support

and guidance on clinical placements. Finally I would like to thank my family for their

continuous support and encouragement throughout this project.

Content

page

1. Major Research Project Empirical Paper 1

1.1 Introduction 2

1.2 Main Hypotheses 12

1.3 Method 12

1.4 Results 20

1.5 Discussion 26

1.6 Conclusion 37

1.7 References 38

1.8 Appendices 48

2. Major Research Project Proposal 71

3.1 Introduction 72

3.2 Method 76

3.3 Procedure 79

3. Major Research Project Literature Review 86

4. Summary of Clinical Experience 122

5. Assessments 124

Major Research Project Empirical Paper

A randomised controlled trial of a brief online mindfulness-based intervention

for paranoia in a non-clinical population

By

Rob Shore

Word Count: 10000

Submitted in partial fulfilment of the degree of Doctor of Psychology (Clinical Psychology)

School of PsychologyFaculty of Arts and Human Sciences

University of SurreyMarch 2015

© Rob Shore 2015

1

Introduction

What is paranoia?

Paranoia is a thought process related to anxiety and fear that tends to involve

pervasive and unfounded suspicion and mistrust of others along with the interpretation that

the threatening or derisive actions of others are deliberate (Fenigstein, 2001). Paranoid

thinking can involve persecutory delusions and ideas of reference where people wrongly

perceive that they are the target of others’ harmful thoughts and actions. Indeed it is

considered that persecutory delusions contain two distressing concerns; that harm is

occurring or going to occur and that others intend that harm (Freeman & Garety, 2000).

Research evidence indicates that paranoid thinking is common in non-clinical populations

(Ellett, Lopes & Chadwick, 2003; Freeman et al., 2011; Johns et al., 2004). It has been

theorised that paranoia can be experienced on a continuum and Freeman et al. (2005)

proposed a hierarchy of paranoia. At the bottom of the hierarchy is the most common form of

paranoid thought which relates to social evaluative concerns. The next step on the hierarchy

involves ideas of reference, and then persecutory thoughts with mild, moderate and finally

severe levels of threat attached to them. The implication is that the prevalence of people

experiencing these thoughts decreases as you go up the hierarchy, with social evaluative

concerns being common in the general population and persecutory thoughts of severe threat

being relatively rare and more characteristic of clinical presentations. It is implicit within the

hierarchy that the more severe paranoid thoughts are built upon the common social evaluative

concerns experienced throughout the general population.

The theory that paranoia is on a hierarchical continuum suggests that it is a feature of

human experience that is present and can be studied in clinical and non-clinical samples

(Freeman et al. 2011, Freeman & Garety, 2014). Furthermore, studies have indicated that

paranoia has implications for the general population with regard to their health, emotional

2

well-being and social functioning and have shown paranoia to be distressing in the non-

clinical population (Freeman et al. 2011, Ellett et al, 2003). Indeed, in a sample of 1,202

university students approximately 10-20% experienced paranoid thoughts that caused them

significant distress (Freeman et al., 2005). Furthermore it has been suggested that paranoia is

increasing in both general and clinical populations (Combs, Michael & Penn, 2006; Combs,

Penn & Fenigstein, 2002). Therefore it is important that effective interventions are available

for people experiencing distress from paranoia irrespective of whether this is part of a clinical

or nonclinical presentation. This is consistent with recent calls in the literature for the need to

markedly improve psychological interventions for delusional (including paranoid) beliefs

(Freeman & Garety, 2014; van der Gaag, Valmaggia, & Smit, 2014). Indeed, cognitive

behavioural therapy (CBT), which is the main psychological intervention recommended for

psychosis by the National Institute for Health and Care Excellence (NICE; 2014), has been

found to only have a small effect on delusions (n=9; g=0.36, 95% CI (0.08, 0.63); van der

Gaag et al, 2014). Therefore it is necessary for research to investigate the effectiveness of

alternative psychological interventions for paranoid thinking.

Mindfulness-based interventions

The principles of mindfulness originate from Buddhist traditions and meditation

practices. Mindfulness practice involves cultivating aspects of awareness, insight and

compassion (Kabat-Zinn, 2000). A widely cited definition of mindfulness defines it as “the

awareness that emerges through paying attention on purpose, in the present moment, and

nonjudgmentally to the unfolding of experience moment by moment” (Kabat-Zinn, 2003, p.

145). It is believed that this way of attending can be cultivated using mindfulness meditation

practices and there are a number of mindfulness exercises available (Baer, 2003). Although

these exercises vary in their focus with some training attention on external stimuli and others

3

on internal experiences, their common principle is to attend to the present in an accepting and

non-judgemental manner.

The aim of mindfulness-based interventions (MBIs) is to teach people mindfulness

skills through in-session and home-based mindfulness practice combined with discussion

about what was learnt from the practice. As such MBIs can be defined as involving an

invitation to practice mindfulness on a daily basis and providing opportunities to reflect on

learning from the mindfulness practice. MBIs are often delivered to groups by trained

mindfulness teachers; however they can be administered individually in person or via self-

help methods such as books or online courses (Cavanagh et al. 2014). At present Mindfulness

Based Stress Reduction (MBSR; Kabatt-Zinn, 1990) and Mindfulness Based Cognitive

Therapy (MBCT; Segal, Williams and Teasdale, 2002) are two of the most commonly

practiced and researched MBIs. They tend to consist of eight sessions with each session

lasting between two and three hours. They also involve in-session and home-based daily

mindfulness practice of between 30 and 40 minutes. Reviews of studies involving MBSR and

MBCT have supported the use of MBI for depression, generalised anxiety, chronic pain and

other physical health problems (Baer, 2003; Grossman, Niemann, Schmidt & Walach, 2004;

Hofmann, Sawyer, Witt & Oh, 2010). Indeed, MBCT is a recommended relapse prevention

treatment for recurrent depression for people who are currently well and have experienced

three or more episodes of depression (NICE, 2009).

Evidence for standard MBIs

A meta-analysis of MBIs conducted by Khoury et al. (2013) examined the

effectiveness of MBIs with clinical and non-clinical populations. Pre-post studies targeting

psychological disorders (n=26) found a medium effect size (Hedge’s g=0.57; 95%

confidence interval (CI; 0.46, 0.69)) where g=0.20 represents a small effect size, g=0.50 a

4

medium effect size and g=0.80 a large effect size (Cohen, 1988). Conclusions from pre-post

studies are limited because change may have occurred with no intervention; therefore studies

using a control group provide more robust evidence and are therefore more convincing.

Waitlist controlled studies targeting psychological disorders (n=18) found a medium to large

between-group effect size (g=0.70; 95% CI (0.48, 0.92)). Among psychological disorders,

waitlist controlled studies targeting anxiety displayed the largest mean effect size (n=4;

g=0.96; 95% CI (0.67, 1.24)), followed by depression (n=8; g=.53 (95% CI (.32, .73).

Studies comparing MBIs with active control conditions such as other potential interventions

give more understanding of the specific effects of MBIs. Studies using a psychological

treatment as a control showed a small between-group effect size (g=0.22; 95% CI (0.12,

0.33)). However, no differences were found when MBIs were compared to traditional CBT or

behaviour therapies (n=9; g=−0.07; 95% CI (−0.26, 0.16)), and pharmacological treatment

(n=3; g=0.13; 95% CI (−.11, .37)). A meta-analysis of MBIs conducted in the workplace for

psychological distress in working adults found that studies comparing MBIs to an inactive

control displayed a moderate to large mean between-group effect size (n=10; g=0.68; 95%

CI (0.48, 0.88); Virgili, 2013). Furthermore, meta-regression analysis demonstrated that

effect size was unrelated to length of intervention, and therefore suggested that with working

adults, briefer MBIs (4-6 weeks) may be no less effective at reducing psychological distress

than standard 8 week courses. In summary, the evidence from these meta-analyses suggests

that MBIs are effective at targeting depression and anxiety in both non-clinical and clinical

mental health populations. Additionally, with a non-clinical working population, it may be

possible for the benefits of MBIs to be realised through a briefer intervention rather than a

standard eight session course.

5

Brief and self-help MBI

The time and resource-intensive nature of mindfulness courses can be prohibitive to

potential participants and service providers. One way of increasing the availability and

accessibility of MBI is to reduce the length of courses and to reduce the duration of face-to-

face teacher contact. To date there have been relatively few studies using brief MBIs of fewer

than four sessions however those that have been conducted have shown promising results for

the effectiveness of brief MBIs on a range of outcome measures. Two studies using an MBI

comprising of three 20 minute sessions over three days with a non-clinical population found

MBI to have a greater pre-post effect on negative mood (eta squared (ɳ2)=0.52) in

comparison to both active (ɳ2=0.16) and inactive control groups (ɳ2=0.17; Zeidan et al.

2010a) and to reduce pre-post ratings of pain (ɳ2=0.82; Zeidan et al. 2010b). Another study

compared three 45 minute sessions of mindfulness meditation to three sessions of hatha yoga

and a waitlist control with a non-clinical population (Call et al., 2014). The mindfulness and

hatha yoga groups had significantly lower pre-post reductions in anxiety and stress compared

to the waitlist control (Call et al., 2014). Despite the lack of research into brief MBIs, these

studies suggest that they can be an effective treatment for psychological distress such as

anxiety and depression in non-clinical populations.

Accessibility of MBI can be further increased by using self-help resources such as

books, audio recordings, online courses or smartphone apps. A meta-analysis of self-help

interventions that involved mindfulness or acceptance-based components with both clinical

and non-clinical populations found them to be effective on measures of mindfulness (g=0.49;

95% CI (0.23, 0.76)), depression (g=0.37; 95% CI (0.18, 0.56)) and anxiety (g=0.34; 95% CI

(0.10, 0.56)) in comparison to a control (Cavanagh et al., 2014). Computerised versions of

CBT have been widely used for psychological difficulties such as anxiety and depression

with research indicating that they are an effective, acceptable and practical intervention for

6

anxiety and depression (Andrews et al. 2010). However, at present there are very few studies

assessing the effectiveness of computerised online MBIs. Of the studies reviewed by

Cavanagh et al. (2014), two used a computerised online MBI. Gluck & Maercker (2011)

compared a two week, web-based MBI to waitlist control with 49 self-referred adults who

were invited to practice mindfulness modules on 12 out of 14 days; they found no post-

intervention between-group effect on anxiety. Morledge et al (2013) used an eight week

web-based MBI and compared it to a no intervention control group with 367 non-clinical

participants and found a medium post-intervention between-group effect on a measure of

anxiety (g=0.50). Not included in the meta-analysis was a study by Cavanagh et al. (2013)

that invited participants to practice mindfulness daily for 10 minutes using a two week online

MBI course in comparison to a waitlist control in an adequately powered study involving a

non-clinical sample of 104 students. On measures of mindfulness, perceived stress, anxiety

and depression they found moderate post-intervention between-group effect sizes ranging

from d=0.41 to d=0.62.

The results from these randomised controlled trials (RCTs) of computerised MBIs

demonstrate the potential effectiveness of this type of intervention, however the results are

inconsistent. Furthermore, the relatively small number of studies completed at present

evaluating the effects of computerised MBIs limits the conclusions that can be drawn about

this approach. Moreover, all the studies display heterogeneity in the method and content of

computerised MBI and all use different measures and samples, further restricting the

conclusions that can be drawn from the results. It is also apparent that the study by Gluck &

Maercker (2011) was under-powered to detect anything but large between-group effect size

and therefore non-significant findings may simply represent a type II error. Another

limitation of these studies was that they did not use an active control condition and this limits

the conclusions that can be drawn regarding the specific benefits of mindfulness practice.

7

Therefore, there is clearly a need for further research of computerised MBIs before definitive

conclusions can be made about its effectiveness.

In summary, there is strong evidence that standard courses of MBSR and MBCT are

an effective treatment for anxiety, depression and stress. At present, brief and computerised

MBIs are a relatively novel way to deliver MBIs, however demand for them is increasing

given their relatively low cost and resource requirements (Segal, 2011). There have been

some promising results suggesting they can be an effective intervention for clinical and non-

clinical populations. Nevertheless, further research of computerised MBIs is required to

better understand their effectiveness. It is also apparent from the above review that despite

increasing support for the clinical benefit of MBI for anxiety and depression, there is much

less evidence regarding MBI for more complex mental health problems such as paranoia.

Mindfulness for paranoia

A systematic review of studies involving MBI that use specific mindfulness practice

with people experiencing symptoms of psychosis highlighted that there is very little research

on MBI for specific symptoms of psychosis such as paranoia (Shore, 2013). It is difficult to

draw conclusions about paranoia from evaluation of psychological therapies on psychosis and

schizophrenia. Their focus is on a diagnosis that relates to differing patterns of a wide range

of symptoms that may or may not include paranoia. In fact, it has been argued that

schizophrenia is not a valid object of scientific enquiry because of its poor reliability, validity

and aetiological specificity, which has resulted in researchers adopting an individual

symptom approach (Bentall, Jackson & Pilgrim, 1988), focusing on examining specific

psychotic symptoms, such as persecutory delusions.

Further research into the effect of MBI on paranoia is important for several reasons.

First, psychological interventions for delusions (including paranoia) show smaller effect sizes

8

than for hallucinations (delusions, g=0.24; hallucinations, g=0.46; van der Gaag et al., 2014),

suggesting a need to markedly improve interventions for delusions specifically (Freeman &

Garety, 2014). Second, paranoia is an aspect of psychosis that can be particularly difficult to

treat using the cognitive reappraisal approach of CBT (Ellett, 2013). The reduction of distress

related to paranoia might therefore be better realised through a mindful approach that can

reduce distress without directly challenging the content of beliefs. Indeed, it has been

suggested that experiential acceptance from MBI may be more effective than cognitive

reappraisal from CBT for people experiencing distress related to symptoms of psychosis such

as paranoia (Vilardaga et al., 2013). It has been theorised that an MBI could encourage the

practice of letting go of reactions such as self-judgement and rumination on paranoid

thoughts (Chadwick et al., 2009). Through this practice individuals can begin to observe and

accept paranoid thoughts and therefore reduce the distress related to that experience.

Therefore an evaluation of an MBI specifically for paranoia is needed to see if MBI might

help to reduce distress related to paranoia.

Research has begun to focus on the effectiveness of MBIs for single symptoms of

psychosis such as voice hearing (Dannahy et al, 2011; Goodliffe et al, 2010; May et al, 2012).

However there is a shortage of research into the impact of mindfulness on paranoia and

persecutory delusions specifically. Chadwick et al. (2009) conducted a study that randomly

assigned 22 participants with distressing voices and paranoia to either an MBI of ten sessions

over five weeks with home practice continuing for a further five weeks or a waitlist control.

They found no significant between-group differences post-intervention, however a moderate

between-group effect size was found on the CORE (d=0.56). Due to the small sample size

the study was underpowered to detect anything other than a large between-group effect size.

This means it is not possible to draw definitive conclusions from this study about the

effectiveness of MBI for psychosis and paranoia.

9

Only one study to date has investigated the impact of mindfulness on persecutory

delusions in the absence of voices, using a single case design (Ellett, 2013). In this study an

individual, six-session mindfulness intervention was used following the protocol from

Chadwick et al. (2005). The two participants who took part in the study were both men with

current distressing paranoid beliefs, who were naive to meditation, and had never experienced

voices. Ratings were taken of persecutory belief dimensions using visual analogue scales at

end of each session and once between sessions. The Southampton Mindfulness Questionnaire

(SMQ) and the Hospital Anxiety and Depression Scale (HADS) were used at baseline, end of

treatment and one month follow up to assess levels of mindfulness, anxiety and depression.

The results showed reductions in key dimensions of paranoid beliefs (conviction, distress,

and preoccupation), depression and anxiety, and increases in mindfulness scores. Positive

behaviour change was also reported by participants and validated by professionals working

with them. The participant scores on the HADS indicate that one participant changed from

clinical levels of anxiety and depression to non-clinical levels, while the other participant

changed from clinical levels to borderline clinical levels of anxiety and depression (Snaith,

2003). These changes were sustained over the one month follow up period, however no data

were reported regarding reliable change. Therefore, it is not possible to fully establish

whether these improvements were mediated by mindfulness or other extraneous factors.

Nevertheless, considering the strong theoretical rationale supporting mindfulness-based

approaches to treating paranoia and the promising initial results from studies, additional

research using methodologically robust designs examining the effectiveness of MBIs for

paranoia are now warranted.

The current study

The present study uses an experimental RCT design to investigate whether a brief

online MBI can reduce the level of paranoia in a non-clinical population when compared to a

10

waitlist control condition, and whether improvement in mindfulness skills mediates the

relationship between intervention type (MBI vs Waitlist Control) and reductions in paranoid

thinking. The study focuses on paranoia because it has been shown to be prevalent and

distressing in the general population, almost as common as anxious and depressive symptoms

(Johns et al., 2004) and it has been suggested that suspicious thoughts are a weekly

occurrence for 30-40% of the population (Freeman et al., 2005). Furthermore, paranoia is

associated with health, emotional well-being and social functioning in the general population

(Ellett et al, 2003; Freeman et al. 2011), and has been proposed to be on a continuum with

clinical paranoia (Combs, Michael & Penn, 2006). However, at present there is no research

investigating whether MBIs can benefit people with paranoia in the general population.

This study will use a brief online MBI because demand for MBI is increasing and

given the relatively low cost and resource requirements of brief MBIs, they could be an easily

accessible intervention for non-clinical populations. Additionally, there is promising evidence

for brief online MBIs for anxiety and depression (Cavanagh et al., 2014). The theoretical

rationale supporting MBIs for paranoia would suggest that the benefits of brief MBIs may

also extend to paranoia however at present we do not know if that is the case. Furthermore,

the nature of paranoia can make it difficult for people experiencing high levels of paranoia to

attend a group-based intervention. As such, an online intervention may be particularly

suitable for paranoia as it allows people to learn about mindfulness and practice mindfulness

without having to attend a group-based intervention.

11

Main Hypotheses

The study will test the mediation model shown in Figure 1 using the following

hypotheses:

1. Participation in an online MBI will lead to significantly greater reductions in paranoia

at post-intervention and follow-up compared to a waitlist control

2. There will be a significant indirect effect from intervention type (MBI versus waitlist)

to improvement in paranoia (from baseline to 1-week post-intervention) via increase

in mindfulness (from baseline to immediately post-intervention).

Figure 1. Proposed mediation model

Method

Design

This was an RCT with random assignment to experimental treatment condition (MBI)

and a wait-list control condition. The independent variable (X) was the experimental

condition (MBI versus no-intervention), the mediator (M) was change in mindfulness skills

pre- to post-intervention and the dependent variable (Y) was change in paranoia scores on the

12

MImproved mindfulness skills (Path b)(Path a)

XMBI Vs waitlist

YReduced paranoia(Path c)

(Path c’)

paranoia scale pre- to one week post-intervention. This allowed for changes in the mediator

to be measured prior to changes in paranoia. Repeated measures were taken at baseline, after

the two week intervention and at follow-up one week after the intervention for each

condition.

This study was part of a larger study with three conditions conducted in collaboration

with a wider research team that included another trainee clinical psychologist. The third arm

in the wider study was a guided visual imagery intervention used as an active control

condition. Only the measures and analyses that test the specified hypotheses are reported in

this paper.

Participants

Previous research using a matched online MBI found medium effect sizes ranging

from d=0.41 to d=0.62 on measures of mindfulness, stress, anxiety and depression (Cavanagh

et al., 2013). Taking this into account medium effect sizes were assumed in paths a and b of

the mediation model shown in Figure 1. Therefore, to test the mediation model with 80%

power (p=.05) in a bias-corrected bootstrapped mediation analysis, a minimum of 36

participants per condition were needed (Fritz & MacKinnon, 2007). Therefore, with two

conditions, 72 participants providing full data at all three time points were needed for the

study.. With the potential for high attrition rates in online MBI (approximately 50%;

Cavanagh et al., 2013) this study aimed to recruit 144 participants with 72 in each condition

to allow for a 50% drop-out rate. For participants to be included in the study they had to be

over 18 years of age, able to understand English and they had to have capacity to consent to

the study.

Participants were an opportunistic sample of 110 people who had responded to verbal

invitations and posters at the University of Surrey or to posts on social media sites Facebook

13

and Twitter. The sample was 11% male and 89% female and age ranged from 18 to 67 years

old (mean (M): 32.16 years, standard deviation (SD): 13.57 years). Part-time or full-time

students made up 48% of the sample. 90 participants (82%) reported that they were from the

UK, with 16 (15%) reporting that they were not from the UK and 4 (4%) choosing not to give

information about country of origin.

Materials

Online mindfulness-based intervention

The ‘Learning Meditation Online’ intervention was the intervention used in Cavanagh

et al. (2013) with some minor adaptations. It was a webpage hosted by the University of

Surrey using Sawtooth Software technology (Sawtooth Software Inc. SSI WEB program

v8.3, Sequim, Washington, 2013). The intervention invited participants to listen on a daily

basis for two weeks to a 10 minute guided mindfulness exercise. There were two recordings

of the same exercise available to participants, one in a male voice and one in a female voice.

Participants were also encouraged to bring mindfulness into their daily activities with

suggestions of how they might do this over the two week period. The webpage was broken

down into six sections (see Appendix A). The first section ‘what is mindfulness’ contained

information about the purpose and benefits of learning mindfulness with a five minute video

clip introducing the concept of mindfulness. The second section ‘daily mindfulness practice’

provided a 10 minute guided mindfulness meditation in a male and female voice that was

based on Chadwick (2006). Section three ‘everyday mindfulness activities’ provided

information on how to bring mindfulness to everyday activities. The fourth section had

frequently asked questions with answers to provide information about what to expect when

practicing mindfulness. Section five contained information about the study and section six

gave contact details for help and assistance such as counselling services and mental health

14

charities. The webpage was self-guided and email addresses of researchers and supervisors

were only provided in case of technical difficulties.

Measures

The full study used a range of measures however the subset of measures relevant to

the specified hypotheses in this paper is described here. For a list of the full set of measures

see Appendix B. The full set of measures totals 187 items and is similar to the number of

items used by Cavanagh et al. (2013).

Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006; Appendix C)

The FFMQ is a self-report scale that is used to measure how mindful participants are

in their daily lives. It has 39 items with each item rated on a five point Likert-type scale from

1 ‘never or rarely true’ to 5 ‘very often or always true’ and total scores for the FFMQ range

between 39 and 195. It identifies five independent facets of mindfulness and therefore allows

investigation into which aspects of mindfulness might be mediating change. At present it is

the most commonly used mindfulness questionnaire and it is based on a factor analysis of

items from five frequently used mindfulness questionnaires (De Bruin et al., 2012).

Furthermore, it has been used widely in other evaluations of MBI and allows for comparison

of effect sizes with other studies. The scale has demonstrated adequate to good internal

consistency for all five facets (Cronbach’s alpha [α]=0.75 – 0.91). The five factors have been

shown to be robust for different types of samples including meditators, non-meditators,

students and the general population (Baer et al., 2006; Baer et al., 2008). Evidence has

consistently emphasised the construct validity of the FFMQ, indicated by significant inter-

correlation between the facets representing an overarching mindfulness construct as well as

the mindfulness facets being significantly related to meditation experience and psychological

well-being (Baer et al., 2008). Convergent and discriminant validity has been demonstrated

by correlating facets of the FFMQ with other psychological constructs such as acceptance,

15

depression and anxiety (Bohlmeijer et al., 2011). Cronbach’s alpha for the full FFMQ in the

current study was .94.

The Paranoia Scale (Fenigstein & Vanable, 1992; Appendix D)

The Paranoia Scale has twenty self-reported items with each item rated on a five point

Likert-type scale from 1 ‘not at all applicable’ to 5 ‘extremely applicable’ with a range of

total scores between 20 and 100. It was developed to measure paranoia in college students

and is the most widely used measure of paranoia and therefore will allow comparisons with

other paranoia research. It has demonstrated good internal reliability (α=0.84) and good test

re-test reliability (r=0.70). Construct validity has been evidenced by its association with the

feeling of being watched (a behavioural criterion of paranoia) and moderate levels of shared

variance with other psychological variables associated with paranoid symptomology

(Fenigstein & Vanable, 1992). In a sample of college students the mean total score on the

paranoia scale (on a range of 20-100) was 42.7 (SD=10.2). Therefore, there was sufficient

variation in scores for the scale to be considered suitable for use with a non-clinical

population. Cronbach’s alpha for the scale in the current study was .92.

Participant Engagement Questionnaire (PEQ; Appendix E)

This questionnaire was used to assess participant engagement with the brief online

MBI over the previous week. It was adapted from Cavanagh et al. (2013) and was made up of

five questions. The first two questions enquired about the amount of time (free text) and the

number of days (0-7) they spent engaging in course materials, not including the meditation

practice. The next two questions enquired about the amount of time (free text) and the

number of days (0-7) they spent actually listening to the audio meditation and engaging in

meditation practice. In order to assess participants’ experience of the intervention the final

16

question used a Likert scale to enquire how much participants felt the intervention was

improving their wellbeing (1 = not at all to 9 = very much).

Ethical considerations

The study was approved by the University of Surrey ethics committee (Appendix F)

and online informed consent was gained from each participant prior to beginning the study.

The study adhered to the ethical guidelines for internet-mediated research published by the

British Psychological Society (BPS; 2013)

The measures used in this study were not diagnostic instruments, and participants

were not given feedback on any of the questionnaires administered. Nevertheless, any

participant who contacted the researcher and expressed a concern about their mental health or

about their responses to the questionnaires were thanked for letting us know, their

experiences were normalised and contact details for a range of sources of support were

provided. Support was not given by any of the researchers involved in the study, as we were a

research team and not providing a clinical service. The participant information sheet and

debrief sheet suggested that any concerns about responses to any of the questions could be

discussed with their GP, the university wellbeing centre or a telephone service such as the

Mind support line.

Due to there being an inactive control group, it was made clear to participants signing

up for the study that they may not receive an intervention. Furthermore, all advertising for the

study made this explicit. Participants who were assigned to the control condition gained

access to the online mindfulness intervention once they had completed the study.

17

Procedure

The study was advertised using posters and flyers at the University of Surrey and

links were posted once a fortnight on social media sites Facebook and Twitter (see

Appendices G, H & I). Adverts provided a hyperlink to the participant information sheet and

consent form. Once informed consent was given participants were requested to complete the

baseline questionnaires online. Within seven days of baseline questionnaires being completed

participants were allocated to either begin the intervention or to a wait-list control condition.

A researcher blind to participant information generated a block randomisation sequence in

blocks of six. A second researcher used the block randomisation sequence to randomly

allocate a group condition to each participant number once baseline measures were

completed. This allowed researchers to remain blind to group allocation. The intervention

was accessible via a hyperlink supplied to participants. Once the site was accessed by

participants they had to input the password they had been provided in order to restrict access

to people not participating in the study. This allowed for the collection of usage data from the

website indicating the frequency and duration of website access for each participant. After

one week the participant engagement questionnaire was sent to those in the intervention

group to assess their level of engagement with the course and to remind them to continue

accessing the material. After two weeks (at the end of the intervention period) all participants

were sent a hyperlink to complete the full battery of measures, those in the intervention group

had the engagement questions included in their battery to assess their level of engagement

with the course over the second week. All participants were then asked to complete all the

measures again online one week after the intervention had ended (i.e. three weeks after

commencing the study). Those on the wait-list were given access to the site at the end of the

study once follow-up measures were completed.

18

Statistical analysis

Data checking

Comparisons were made of means and standard deviations at baseline to check for

differences between groups prior to randomisation in order to check group equivalence. All

data were checked for whether the assumptions for multiple regression were met. Residuals

from each path of the mediation model (see Figure 1) were checked for normality of

distribution, homoscedasticity and independent errors. Predictor variables were checked for

zero variance and multicollinearity. Outcome variables were checked for independence and

linearity and outliers were checked using Cook’s distances. Unless otherwise stated the

assumptions of multiple regression were not violated. Means and standard deviations for each

variable within each condition at each time point were reported (Table 2). All statistical

analyses were computed at p<0.05.

Data analysis

To test hypothesis one, a mixed ANOVA was conducted with post hoc tests, where

warranted, exploring the effects of group (MBI or waitlist) and time (baseline and follow-up)

on paranoia scores. The mediation analysis (to test hypothesis 2) was conducted using the

PROCESS macro for SPSS (Hayes, 2013) using 5000 resamples and Bias Corrected and

Accelerated Confidence Intervals (BCa CI). This gives total and indirect effects with both

bootstrapping confidence intervals and the product-of-coefficients approach. Bootstrapped

95% confidence intervals for the a x b effect were used to test Hypothesis 2. This approach is

more powerful than the Baron and Kenny (1986) causal steps approach with a lower risk of

type II errors. It is also more robust in the event that multiple regression assumptions are

violated, and it does not incorrectly assume that path c needs to be significant in order for

mediation to occur (Hayes, 2008). It is not recommended that intention-to-treat analysis is

19

used to test for mediators in psychological therapies because it is important that participants

received an adequate amount of the intervention to test for mediation (Kazdin, 2007).

Unstandardised Beta (β) coefficients for the pathways on the mediation model are reported

and Kappa-squared (K2; Preacher & Kelley, 2011) is reported with confidence intervals as a

standardised effect size.

Results

There were 110 participants randomly allocated to either the online MBI or to the

waitlist control condition. Thirty-one (28%) participants dropped out before completing the

post-intervention and follow-up measures; 20 (18%) from MBI and 11 (10%) from Waitlist.

There was not a significant difference in completion rates between the groups, t(106) =-1.80,

p=0.07. No significant differences were found between participants who completed and those

that dropped out with respect to age (t(83)=0.24, p=.81), gender (t(41)=1.51, p=.14) or

baseline scores on the paranoia scale (t(108)=-0.93, p=.35) and FFMQ (t(108)=-0.74, p=.46).

Fifty-eight participants completed measures at all three time points (28 (48%) MBI, 30 (52%)

Waitlist) with 71 only completing the baseline and post-intervention measures (34 (48%)

MBI, 37 (52%) Waitlist) and 66 only completing the baseline and follow-up measures (30

(45%) MBI, 36 (55%) Waitlist). A consort diagram outlining the participant flow through the

study is shown in Figure 2. Sixty participants (29 (48%) MBI, 31 (52%) Waitlist) completed

baseline and post-intervention measures on the FFMQ and baseline and follow-up measures

on the paranoia scale and were therefore included in the mediation analysis.

20

Figure 2. Consort diagram outlining the participant flow through the study.

Descriptive analyses

Sample characteristics for each condition at baseline are displayed in Table 1. There

were no significant between-group differences concerning age (t(108)=-0.24, p=.81), gender

(χ2(1)=3.13, p=.08), ethnicity (Fisher’s exact test (FET)=8.32, p=.36), whether they lived in

the UK (χ2(1)=0.21, p=.65), and level of education (FET=6.00, p=.56).

21

Consent given and baseline

questionnaires completed

N=110

Randomisation

Allocated to waitlist controlN=54

Allocated to MBI

N=56

Completed Post Intervention measures

N=37

Completed Post Intervention measures

N=34

Completed one week follow-up measures

N=30 + 6

Completed one week follow-up measures

N=28 + 2

Withdrew

N=11

Withdrew

N=20

Did not complete Post but did complete

follow-up measuresWait=6, MBI=2

Withdrew

N=7

Withdrew

N=6

Analysis of the outcome variables at baseline indicate the paranoia scale and FFMQ

were significantly correlated (r=-0.45, p<0.001) showing that lower mindfulness scores were

associated with higher paranoia scores. No significant between-group differences were found

at baseline on the paranoia scale (t(108)=-0.35, p=.73) or the FFMQ (t(108)=0.09, p=.37).

Pre, post and follow-up mean values and standard deviations for the paranoia scale and the

FFMQ are displayed in Table 2. Effect size calculations for within-group baseline to post-

intervention and baseline to follow-up and between-group at post-intervention and follow-up

are shown in Table 3.

Table 1. Characteristics of the MBI and waitlist groups at baseline

Variable MBI (N=56) Waitlist (N=54) StatisticsMean Age / years (SD) 32.5 (13.5) 31.9 (13.8) t(108)=-0.24, p=.81

Gender - % Female 83.9% 94.4% χ2(1)=3.13, p=.08

Ethnicity FET=8.32, p=.36

% live in UK 83.3% 86.5% χ2(1)=0.21, p=.65

Level of education FET=6.00, p=.56

Table 2. Descriptive statistics for MBI and Waitlist control at all time points

Variable MBI / means (SD; N) Waitlist / means (SD; N)Pre Post Follow-up Pre Post Follow-up

Paranoia Scale†

39.1(13.1; 29)

31.0(10.8; 29)

29.3(10.5; 29)

41.1(13.6; 31)

40.4(13.9; 31)

36.6(12.8; 31)

FFMQ‡ 114.3(20.3; 28)

129.6(14.8; 28)

132.5 (20.4; 28)

115.0 (21.0; 30)

115.0 (19.0; 30)

115.2 (21.0; 30)

†possible range of scores 20 – 100; negative changes are improvements; published mean in non-clinical sample 42.7 (Fenigstein and Vanable, 1992)‡possible range of scores 39 – 195; positive changes are improvements

Table 3. Within-group and between-group effect size calculations

Variable Within-Group Between-groups /effect size (d∆)MBI / effect size (d∆) Waitlist / effect size (d∆)

Pre-post Pre-follow-up Pre-post Pre-follow-up Post Follow-upParanoia Scale

0.67 0.83 0.05 0.34 0.75 0.62

FFMQ 0.86 0.89 0.00 0.01 0.86 0.84∆Cohen’s d

22

Engagement with MBI

Data regarding the level of engagement with the MBI was obtained from the number

of times the MBI website was accessed and from the Participant Engagement Questionnaire

(PEQ) after one week and at post-intervention. The data downloaded from the website relies

on participants correctly inputting their email address each time they access it so the data is

not necessarily accurate. The self-report data from the PEQ is open to social desirability bias

and may also be of questionable accuracy; therefore the usage data should not be used for

further analyses. However the data suggested that all participants in the MBI group included

in the mediation analysis accessed the intervention, either from records on the website or

from self-reports on the PEQ. A summary of the data from the PEQ and the MBI website is

shown in Table 4.

Table 4. Summary of the usage data from the PEQ and the MBI website

≥1 access to MBI site (website data)

PEQ completed

≥1 access to MBI site (PEQ & website data)

No. of days self-reported practice (PEQ)

Total no. of times website accessed (website data)

26 (90%) 24 (83%) 29 (100%) Range= 5 - 16M = 11.83SD = 3.68

Range = 0 - 23M = 6.07SD = 6.43

Hypothesis 1: Participation in an online MBI will lead to significantly greater

reductions in paranoia at post-intervention and follow-up compared to a waitlist control

In an intention to treat analysis, a mixed ANOVA was conducted to test hypothesis 1

in order to explore the effects of group (MBI or waitlist) and time (baseline, post-intervention

and follow-up) on paranoia scores. There was a significant group by time interaction on

paranoia, F(1.70,98.72)=5.70, p=.01. Within-group t-tests indicated that the MBI group

showed a significant decrease in paranoia over time both baseline to post-intervention,

t(33)=4.18, p<.001, d=0.60, 95% CI for d=(0.11, 1.08), and baseline to follow-up,

23

t(30)=5.34, p<.001, d=0.80, 95% CI for d=(0.27, 1.30). Within-group t-tests for the waitlist

control group showed no significant change in paranoia baseline to post-intervention,

t(37)=0.07, p=.95, d=0.01, 95% CI for d=(-0.44, 0.46). However there was a significant

decrease in paranoia baseline to follow-up in the waitlist control group with a relatively small

effect size, t(36)=2.72, p=.01, d=0.29, 95% CI for d=(-0.18, 0.74). Between-group t-tests

showed a significant difference between MBI and waitlist control at post-intervention,

t(69.9)=2.32, p=.024, d=0.75, 95% CI for d=(0.22, 1.27) and at follow-up, t(66)=2.364,

p=.021, d=0.62, 95% CI for d=(0.12, 1.10).

Hypothesis 2: There will be a significant indirect effect from intervention type (MBI

versus waitlist) to improvement in paranoia (from baseline to 1-week post-intervention)

via increase in mindfulness (from baseline to immediately post-intervention).

Although more robust than standard multiple regression to violations of multiple

regression assumptions, the bootstrapped mediation analysis assumed a linear relationship

between variables, normally distributed residual errors and no overly influential cases.

Scatter-plots showed linearity between variables (Appendix J), histograms of the residuals for

each pathway showed they were normally distributed (Appendix K), and Cook’s Distance

tests were all less than 1.1 indicating no overly influential outliers. Therefore the assumptions

necessary for bootstrapped mediation analysis were satisfactorily met.

Analyses were completed to assess whether baseline to post-intervention change in

mindfulness skills (as assessed by the FFMQ) mediated baseline to follow-up change in

paranoia ratings (as assessed by the paranoia scale). The output from the PROCESS macro

for SPSS (Hayes, 2013) indicated that there was a significant indirect effect of treatment

condition on paranoia change through change in mindfulness skills, β=1.72, 95% BCa CI

(0.66, 3.19). This represents a medium to large effect K2=0.172, 95% BCa CI (0.07, 0.31).

Follow-up within-group t-tests indicated that the MBI group showed a significant baseline to

24

post-intervention increase in mindfulness skills, t(33)=-4.48, p<.001, d=0.86, 95% CI for

d=(0.36, 1.35), while the waitlist control group remained unchanged, t(36)=0.57, p=.57,

d=0.00, 95% CI for d=(-0.46, 0.46). All effects were in the hypothesised direction. The

unstandardised Beta coefficients for the pathways on the mediation model are illustrated in

figure 3.

path c (direct effect, β=0.94, p=0.45)path c’ (indirect effect, β=1.72, 95% CI [0.664, 3.191])

Figure 3. Coefficients for the pathways showing the mediational effect of change in mindfulness score post-intervention on paranoia score at follow-up adjusted for baseline values

Post hoc power analysis

A post hoc power analysis was conducted using the software package, G* Power

(Faul et al., 2007). The sample size of 60 was used for the statistical power analysis with two

groups and three measurement points. The alpha level used for this analysis was p < .05 and

the mean effect size between groups was 0.77. The post hoc analyses revealed the statistical

power for this study exceeded .99.

25

Change in mindfulness skills (pre - post)

Paranoia change (pre - follow-up)

MBT Vs Waitlist

Path a (β=8.18, p<0.001)

path b(β=0.21, p<0.005)

Discussion

Summary of Findings

The first hypothesis investigated by this RCT predicted that participation in an online

MBI would lead to significantly greater reductions in paranoia at post-intervention and

follow-up compared to a waitlist control. There was a significant group by time interaction on

paranoia in the hypothesised direction. The significant between-group effect sizes were

medium to large for paranoia at post-intervention and follow-up, and within-group analyses

in the MBI group showed a significant decrease in paranoia over time from baseline to both

post-intervention and follow-up, demonstrating medium to large effects. There was also a

small but significant decrease in paranoia from baseline to follow-up in the waitlist control

group. This finding may represent regression to the mean with the possibility that some

participants chose to take part in the study because they were experiencing slightly elevated

levels of paranoia. It is also possible that this finding represents an expectancy effect in the

responses of participants. Nevertheless, the findings support our first hypothesis and show

empirically for the first time that a two week online MBI in comparison to a wait-list control

condition, that provides information on mindfulness and invites engagement in a daily ten

minute mindfulness practice via an online platform, can reduce levels of paranoia in a non-

clinical population.

The second hypothesis predicted a significant indirect effect from intervention type

(MBI versus waitlist) to improvement in paranoia (from baseline to 1-week post-intervention)

via increase in mindfulness (from baseline to immediately post-intervention). The results

demonstrated that there was a significant indirect effect of treatment condition on paranoia

change mediated through change in mindfulness skills. The within-group baseline to post-

intervention effect size for mindfulness in the MBI group was large and the between-group

26

effect size at post-intervention was also large suggesting this brief online MBI was effective

in increasing mindfulness skills. Therefore the findings support the second hypothesis and

demonstrate that increases in mindfulness skills mediate the effect of engaging in a two week

online MBI, resulting in reductions in paranoia in a non-clinical population.

Findings in Context: MBIs for Paranoia

At present, there is a scarcity of research investigating MBIs for paranoia. Whilst

there is an emerging evidence base for the effectiveness of MBIs in psychosis and

schizophrenia, it is difficult to draw conclusions specifically about paranoia from this

research because the focus has been on a diagnosis that may or may not include paranoia.

Furthermore, it appears that mindfulness research in this area is limited by a deficiency of

methodologically robust, adequately powered studies. In a review of third wave treatments,

most of which incorporate mindfulness principles, Ost (2008) found that none of the therapies

reviewed fulfilled the criteria for empirically supported treatments. It is important to

thoroughly research the effect of MBIs on paranoia because there is a need to significantly

improve psychological treatments for delusions and paranoia (Freeman & Garety, 2014).

Research has highlighted that psychological treatments for delusions show smaller effect

sizes than for hallucinations (van der Gaag et al., 2014). Furthermore, it has been suggested

that mindful approaches may be more effective than CBT at reducing distress related to

paranoia because mindfulness can reduce distress without directly challenging the content of

beliefs (Vilardaga et al., 2013; Ellett, 2013).

The findings from the current study support those of Ellett (2013) who used an

individual six session MBI for two people experiencing persecutory delusions without

distressing voices. It also extends the current evidence base using a more robust RCT design,

showing that MBIs can be beneficial for people experiencing paranoia. Randomisation

27

reduces the influence of bias and other extraneous factors on the results and the use of a

control condition demonstrates that MBIs are more effective than a waitlist control at

reducing paranoia. Overall, the outcomes from the current study show empirically for the first

time that MBIs can reduce paranoia in a non-clinical population.

In contrast to the findings from the current study, Chadwick et al. (2009) did not find

significant post-intervention between-group differences in paranoia. They compared ten

sessions of a group MBI with a waitlist control for a clinical population of 22 participants and

used the psychotic symptom rating scales (PSYRATS; Haddock, 1999) to assess change in

paranoia. A small non-significant between-group effect on paranoia was found. There are

several possible explanations that may explain these discrepant findings. First, the sample

size in the Chadwick study was only 18 participants, meaning the study was under-powered

to find significant results with anything but a large effect size. Second, the Chadwick study

used a clinical population and the present study examined nonclinical paranoia. Finally,

another explanation might relate to the format of the MBIs employed, as the Chadwick study

used a 12 session group approach, in contrast to the online brief MBI in the current study.

Therefore, it is likely that the contrasting results reflect methodological differences between

the studies.

The present study also found that reductions in paranoia were mediated by

mindfulness. This offers support for research evidence indicating that change in mindfulness

mediates the relationship between MBIs and improved psychological wellbeing. Studies have

suggested change in mindfulness can mediate the relationship between MBI participation and

a range of psychological difficulties, including perceived stress, positive states of mind, post

traumatic avoidance symptoms, depressive symptoms and general psychological functioning

(Baer, 2009; Branstrom et al., 2010; Kuyken et al., 2010). These mediation analyses indicate

that mindfulness is a mechanism of change in MBIs for many psychological symptoms. The

28

results from the present study were the first to establish that mindfulness also mediates the

relationship between MBI participation and paranoia specifically. This adds to the current

understanding about mechanisms of change in MBIs by highlighting that changes to levels of

mindfulness do influence change in paranoia following engagement in a MBI. Moreover,

these findings demonstrate that changes in paranoia following an MBI cannot be exclusively

explained by extraneous factors not related to mindfulness. Therefore, it can be stated with

more confidence that increases in mindfulness gained through MBIs can lead to reductions in

paranoia in a non-clinical population.

Findings in Context: Brief and self-help MBIs

The outcome data from this study extends the current emerging body of evidence

investigating the effectiveness of online self-help MBIs. In contrast to the current study,

Gluck & Maercker (2011) found no between-group effect when they compared a two week

online MBI to waitlist control on a measure of anxiety with 49 self-referred adults. However,

the study was underpowered to detect anything other than large effects and therefore non-

significant findings may represent a type II error. In line with the current study, Morledge et

al. (2013) found an eight week web-based MBI was effective at reducing anxiety when

compared to a no-intervention control group with a large non-clinical sample. In a study

using the same intervention as the current study (with some minor adaptations) in comparison

to a waitlist control, Cavanagh et al. (2013) found moderate between-group effect sizes on

measures of mindfulness, perceived stress, anxiety and depression with a non-clinical sample.

Considered alongside the results from the current study, it appears that this brief two-week

online MBI can improve levels of mindfulness and effectively reduce a range of

psychological symptoms in a non-clinical population. The findings also contribute to the

ongoing debate in the literature regarding the frequency and duration of mindfulness practice

29

needed to facilitate change. In both the current study and Cavanagh et al (2013), engaging in

mindfulness practice for just 10 minutes a day over a two week duration can increase

mindfulness and reduce a range of psychological symptoms. This supports suggestions in the

literature that briefer MBIs with relatively short practices can be an effective intervention

(Ussher et al. 2014; Virgili, 2013; Zeidan et al., 2010a; Zeidan et al., 2010b).

Limitations

The current study has some limitations that should be noted. This study was the first

RCT of MBIs for paranoia and therefore it was an appropriate first step to use a waitlist as an

inactive control condition. However, not using an active control as a comparison meant that

non-specific factors that could be the cause of any change, such as listening online to

someone’s voice for 10 minutes a day, were not controlled for. Furthermore, use of a waitlist

control does not demonstrate whether the MBI was more effective than other interventions

such as CBT. Nevertheless, the use of a mediation analysis with a temporal separation

between outcome data on mindfulness and paranoia gives a strong indication that increases in

mindfulness do lead to reductions in paranoia; thus suggesting that extraneous factors alone

could not explain reductions in paranoia in the MBI group.

An unselected sample was used in this study which potentially created a relatively

homogenous sample that was not representative of the UK population in terms of, for

example, gender, age or ethnicity. The gender ratio was skewed with the majority of

participants being female. This may have been addressed using a wider sampling method,

however there were no significant differences between groups with regard to gender and

there are no indications in the literature that levels of paranoia would be influenced by

gender. A large proportion of participants were students and the sample in general had a

relatively high average level of education. Moreover, the study was not accessible to the

30

hearing impaired and those without access to a computer, further limiting the representative

nature of the sample. As a result, the generalisability of these findings to distressed

community samples is limited and any extrapolation should be made with caution.

Additionally, the use of a non-clinical sample means that conclusions are limited with regard

to the effect of MBI for those with clinical levels of paranoia. Nevertheless, it has been

suggested that paranoia is experienced on a continuum and can cause distress in clinical and

non-clinical populations (Ellett et al, 2003, Freeman et al., 2005, Freeman et al. 2011,

Freeman & Garety, 2014). This would suggest that despite there being differences between

the degree of paranoia experienced by clinical and non-clinical populations, there may be no

difference in the form of paranoia experienced. Therefore it was warranted to investigate

paranoia in a non-clinical sample however, future research would need to establish

effectiveness for people experiencing clinical paranoia.

Levels of mindfulness and paranoia were assessed using self-report measures in the

current study. Use of self-report measures can be a limitation because they rely on

participants’ providing true and accurate reports of their own mindfulness skills and

symptoms of paranoia. This can impact on the reliability and validity of the data via a range

of response biases such as social desirability bias, acquiescence or ‘mid-point’ response set

(Furnham & Henderson, 1982). With respect to mindfulness, it has been suggested that data

from self-report measures could be used in addition to tests of performance on standardised

tasks of attention and awareness to gain a more thorough assessment of mindfulness skills

(Bishop, 2002). Moreover, paranoia self-report measures could be complimented with the use

of behavioural observations or indicators, such as those developed in the Prisoner’s Dilemma

Game (Ellett et al., 2013). However, the use of additional tasks and observations would

increase the demands on the participant and potentially limit the scope of the study by

reducing levels of recruitment and increasing attrition. Furthermore, the self-report measures

31

used in this study have well evidenced reliability and validity (Baer et al., 2008; Bohlmeijer

et al., 2011; Fenigstein & Vanable, 1992) and are widely used in research, which allows

comparability to be assessed across studies.

Participants were allocated to either intervention or control condition within seven

days of completing the baseline measures. This created variability in the length of time for

each participant between completion of baseline measures and completion of post-

intervention measures, with a minimum of two weeks and maximum of three weeks. This

may have influenced the results because if there was natural variation in paranoia over time,

paranoia levels may have changed to a different extent depending on the length of time

between baseline and post-intervention measures. However, this was the same for both the

control and intervention group and therefore it should not have created differences between

the groups. Although this study collected follow-up data, the follow-up period was only one

week. This limited the conclusions that could be made with regard to whether changes in both

paranoia and mindfulness are maintained over a longer follow-up period. One reason that the

follow-up period was kept to one week rather than a longer period of time was to try to keep

rates of attrition as low as possible. This was effective to the extent that similar numbers of

participants completed the post-intervention and the follow-up measures. Furthermore,

attrition from the study prior to completing post-intervention and follow-up measures was

28%. All measures were completed at all three time points by 53% of participants. This level

of attrition had the potential of causing some bias in the data because the participants who

dropped out may have had specific characteristics. However there were no significant

differences between participants who completed and those that dropped out with respect to

age, gender and baseline scores on the paranoia scale and FFMQ. Furthermore there was not

a significant difference in completion rates between the groups. Therefore this level of

attrition may reflect the number of measures required to be completed and the time demands

32

on a non-clinical population with regard to completing the measures and engaging in daily

practice rather than the acceptability of the brief online MBI. It was also apparent that the

attrition rates were comparable to those experienced in other online intervention studies; 72%

completed measures after the intervention compared to an average completion rate of 69%

with internet-based treatments (range 17–98%; Melville, Casey, & Kavanagh, 2010). This

implies that the brief online MBI was relatively acceptable to the participants.

Clinical implications

The current study demonstrated that a two week online MBI involving only ten

minutes of daily guided mindfulness practice for two weeks can reduce levels of paranoia in a

non-clinical population. This is an important finding because it demonstrates the

accessibility, as well as effectiveness, of online MBIs. An MBI such as the one used in this

study could be ideally suited to meet the needs of working people with time commitments

who require the flexibility group interventions cannot provide. Furthermore they may be a

more accessible intervention for people experiencing high levels of paranoia who may find it

difficult to attend a group-based intervention.

The financial and resource costs of providing a brief online MBI are potentially

relatively low making it a cost effective and beneficial treatment for people experiencing

paranoia. This is particularly important given suggestions that paranoia is increasing, can

cause distress in non-clinical populations and impacts on people’s health, emotional well-

being and social functioning (Combs, Michael & Penn, 2006; Combs, Penn & Fenigstein,

2002; Ellett et al, 2003; Freeman et al. 2011). Increasing rates of paranoia could create

increasing demands on public health services and considering the current economic pressures

on health services, an effective low cost treatment for paranoia such as this brief online MBI

may be the best way to help people manage distressing paranoia.

33

Despite the non-clinical population used in the current study, the findings could have

implications for clinical services. The current emphasis in the literature is for specific

symptoms of psychosis to be considered separately in regard to the research and development

of interventions, for example focusing on auditory hallucinations and paranoid delusions

separately rather than collectively as a diagnosis of psychosis or schizophrenia (Freeman &

Garety, 2014; van der Gaag et al., 2014). It has been demonstrated that different interventions

are more effective for different aspects of psychosis and while CBT has been shown to be

moderately effective for distress related to voice hearing, the evidence for CBT for paranoid

delusions is less conclusive (van der Gaag et al., 2014). Therefore it is important to continue

to modify, as well as identify new interventions that are effective for clinical levels of

paranoia.

It has been suggested that mindfulness based approaches may be particularly effective

at reducing distress related to paranoia (Collip et al., 2013; Vilardaga et al., 2013). This is

because MBIs target an individual’s relationship with thoughts and feelings rather than using

strategies such as cognitive reappraisal that aim to change the content of mental experience.

Learning to recognise negative thoughts and feelings in the present moment with the

understanding that they may not represent reality could help to make the experience of

suspicious thoughts less distressing. Therefore, in the context of the results from the current

study evidencing the effectiveness of MBI for paranoia in a non-clinical population, it may be

the case that MBI would also be an effective treatment for clinical levels of paranoia,

although this would clearly need to be established in future research.

The current study highlighted the effectiveness of a brief online MBI for increasing

mindfulness skills and reducing paranoia. If these effects are transferable to clinical

populations then brief online MBIs could be used as a low intensity intervention for paranoid

34

symptoms of mental health problems such as psychosis. The low resource implications and

ease of accessibility of brief online MBIs would make it possible for health care providers to

quickly and efficiently deliver this potentially effective treatment to large numbers of people

experiencing clinically distressing paranoia. Furthermore, when considered with other

potential psychological benefits of mindfulness such as reducing anxiety and depression,

(Cavanagh et al., 2014; Khoury et al., 2013), which have also been found to be common in

individuals with psychosis (Freeman & Garety, 2003), the finding that this brief online MBI

increases levels of mindfulness implies it could be a beneficial initial treatment for a wide

range of symptoms relating to mental health problems such as psychosis.

Directions for future research

The findings from the current study highlight several important directions for future

research. Firstly, and perhaps most importantly, future research is needed to explore whether

mindfulness-based interventions, including in a brief online format, are effective for people

with clinical paranoia. Studies could also investigate the effectiveness of brief online MBIs

for people experiencing paranoia as a symptom of psychosis, anxiety related disorders such

as post-traumatic stress disorder or mood disorders. When researching effects in a clinical

population, randomisation and recruitment of enough participants to find significant effects

can be problematic. However, a better understanding of the effectiveness of brief online MBI

for paranoia with a range of clinical populations will help to guide future treatment protocols

for people experiencing distressing paranoia. Furthermore, research with clinical populations

can help inform whether there is a need to make adaptations to the brief online MBI for

people experiencing clinical levels paranoia, such as using different terminology, changing

the pace of the exercise or changing the length of any pauses. It would also be interesting to

35

determine whether brief online MBIs are effective for this population as a stand-alone

intervention, or as a supplement to ongoing group intervention.

As well as examining effectiveness, it would also be important to conduct qualitative

research examining the acceptability of brief online MBIs; this is also important in the

context of the level of attrition from this and other similar studies. This would help to identify

whether people drop out from the intervention due to its acceptability or whether drop out

levels are more related to external factors such as time demands on a non-clinical population.

This could provide information about whether changes to the length or nature of the exercises

would be beneficial and whether a different total length of intervention should be considered.

It could also be explored whether it is easier or harder to maintain engagement with an online

intervention in comparison to a face to face intervention. This may help to guide how MBIs

are developed in future.

The follow-up measures used in this study showed that changes in paranoia and

mindfulness were maintained for a week following the end of the intervention. However, it

would also be useful to explore whether such changes can be maintained for longer periods of

time such as six months or a year from a brief online MBI. Investigations could assess

whether people continue to access the site and practice mindfulness after the formal two week

intervention period. Additionally, further research could explore whether ongoing practice

has a cumulative effect on reductions in paranoia. It could be useful to assess whether

paranoia levels continue to reduce, level out or return to baseline levels when people either

continue to engage with the intervention or stop engaging with the intervention.

The current study measured paranoia as a general construct using the paranoia scale.

However there are different dimensions of paranoia, such as the frequency, conviction and

distress associated with paranoid thoughts (Chadwick & Lowe, 1994; Freeman et al., 2005).

36

It is possible that different dimensions of paranoia could be impacted differently by

mindfulness. It would be helpful to explore this further in order to better understand the

interaction mindfulness has with different dimensions of paranoid thoughts. It would be

interesting to determine whether the brief MBI reduces the frequency of self-reported

individual experiences of paranoia or whether it impacts solely on the conviction or distress

related to paranoid thoughts.

The mediation analysis from this study identified that mindfulness did mediate the

change in paranoia resulting from the MBI. There are a number of processes such as

rumination and avoidance that are proposed to maintain paranoia (Martinelli, Cavanagh &

Dudley, 2013; Udachina et al., 2013). Future research using MBIs for paranoia could

measure these maintaining processes and assess the extent to which they mediate change in

paranoia. This would give a better understanding of the different mediating factors effecting

change in paranoia through MBIs, thus giving a greater insight into the mechanisms of

change in MBIs and guiding future development of effective interventions.

Conclusion

This study provides the first evidence, using an RCT design, for the effectiveness of a

brief online MBI in reducing paranoia compared to a waitlist control in a nonclinical sample

with improvements shown to be mediated by increases in mindfulness. Further research is

needed to determine whether the benefits gained from the intervention are maintained over

longer periods of time, and to examine effectiveness for those with clinical paranoia.

Nevertheless, this is the first RCT of MBIs for paranoia and the results from this study could

have major implications for how we help people who are experiencing paranoia in both

clinical and non-clinical populations.

37

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Appendices

Appendix A. Text from ‘Learning meditation online’ website

Appendix B. Outcome measures used in wider study

Appendix C. Five Facet Mindfulness Questionnaire

Appendix D. Paranoia Scale

Appendix E. Participant Engagement Questionnaire

Appendix F. Ethics committee approval

Appendix G. Study poster

Appendix H. Study flyer

Appendix I. Social media post

Appendix J. Scatterplots of variables

Appendix K. Histograms of residuals

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Appendix A. Text from ‘Learning meditation online’ website

Learning Meditation OnlineWelcome

Thank you for agreeing to take part in this study and for completing the initial questionnaires.

You have now been given access to this Study Direct site where you will be able to learn about mindfulness, how to use a daily 10 minute mindfulness meditation practice and how to bring mindfulness to your everyday activities.

Learning Meditation OnlineWe recommend you read the ‘What is Mindfulness?’ page before engaging in your first daily mindfulness meditation and mindful activity.

You may also wish to take a moment to explore the site using the menu below to see what is available on the following pages.

What is Mindfulness?Here you will be able to get information explaining the purpose and benefits of learning mindfulness, and how it works. The page also contains useful links to other mindfulness resources if you want to learn more.

Daily Mindfulness PracticeThis page will allow you to access the 10 minute mindfulness practice whenever you wish to use it. To maximize any benefit from the practice, we recommend you try it on a daily basis for the next two weeks.

Everyday Mindfulness ActivitiesThis page provides some information about how to bring mindfulness to everyday activities. To maximize any benefit from the practice, we recommend you try bringing mindfulness to at least one routine activity on a daily basis for the next two weeks.

Daily Practice and Everyday Mindfulness Activities FAQsProvides a little information about what you can expect to experience when practicing mindfulness.

Study Information

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This contains a copy of the information explaining what this study is investigating and what will be asked of you as a participant.

Help and AssistanceIf you have any questions or concerns about the study, you can find contact details for the researchers as well as links to external support agencies on this page.

Once again, thank you for agreeing to participate in this study. The mindfulness course lasts for two weeks, and you will have access to the site for a further two weeks after the end of the course. We hope you enjoy learning about the benefits of Mindfulness and how to bring mindfulness to your daily life.

What is Mindfulness?Professor Jon Kabat-Zinn briefly introduces the idea of mindfulness in the following video...

Youtube video link: https://www.youtube.com/watch?v=HmEo6RI4Wvs&feature=player_embedded

The term mindfulness comes from Eastern spiritual and religious traditions, but psychology has begun to find that mindfulness (without the spiritual and religious context) can be helpful for people in many ways. Regularly practicing mindfulness has been shown to have a number of benefits including;

• Improving our concentration and the clarity of our thinking and intentions• Helping us to handle stress• Fortifying our self-confidence• Strengthening our resilience and ability to cope with change• Enhancing the quality of our communications and relationships• Enabling a deeper peace of mind and sense of flow

Mindfulness is paying attention in the present moment, with openness and curiosity, instead of judging experiences as good or bad or right or wrong. We often focus on things other than what is happening in the moment- worrying about the future, thinking about the past, focusing on what is coming next rather than what it right in front of us. Sometimes it is useful that we can do a number of things without paying attention to them. However, sometimes it is helpful to bring our attention, particularly a curious and kind attention, to what we are doing in the moment.

Sometimes we do pay close attention to what we are thinking and feeling and we become very critical of our thoughts and feelings; we try to change them or distract ourselves because this critical awareness can be very painful. For example, we might notice while we are talking to

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someone new that our voice is shaky, or we aren't speaking clearly, and think, "I'm such an idiot! What is wrong with me? If I don't calm down, this person will never like me!"

We often find ourselves responding to unpleasant experiences by fighting against them, getting caught up with them or by trying to ignore them. Mindfulness is a 'middle way' of responding to unpleasant experiences. It allows us to notice experiences without getting drawn in to them, without fighting against them and without trying to push them away. Rather mindfulness allows us to notice experiences in each moment, step back and 'watch' these experiences without judgement, and allow them to fade and pass as new experiences come into awareness. For example, when talking to someone new we might notice those same changes in our voice and take a moment to reflect, "This is how it is now, there go my thoughts again," and gently bring our attention back to the person and our conversation. This second part of mindfulness, holding our judgments loosely and not trying to change our thoughts or feelings can be especially hard. In fact, often being mindful involves practicing not judging our tendency to have judgments.

Each of these aspects of mindfulness are worth taking a little time to consider:• Mindfulness involves paying attention on purpose. We decide to pay attention.• The object of our attention is the present moment. This includes whatever experiences we notice in each moment. We might notice sounds, sensations in our bodies, thoughts and feelings.• Mindfulness encourages us to notice these experiences non-judgmentally. We try, as best we can, to notice current experiences without judging them as right or wrong, or as good or bad. Not judging our experiences takes a lot of practice. You might notice judging things about:• Yourself (e.g. "I can't do this, I can't do anything")• Thoughts (e.g. "I shouldn't be thinking this")• Mindfulness practice (e.g. "this is a waste of time")

The aim of mindfulness is to notice these judgments and to bring our attention back to the present moment.

What can Mindfulness do for me?

Mindfulness will not get rid of unpleasant thoughts or feelings, but with practice we can learn to notice unpleasant experiences without getting caught up with them. Mindfulness is not a relaxation technique, although some people notice that they feel more relaxed after practicing mindfulness. Other people, particularly when they first start practicing mindfulness, might notice that they get drawn into unpleasant thoughts and feelings and that they get caught up in these experiences.

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If this happens for you, try as best as you can to step back from these unpleasant experiences, watch them fade and pass as if you could see them on a screen, as clouds drifting in a summer sky or leaves floating down a stream, and then gently bring your attention back to the present moment. If you are able to do this just once while practicing mindfulness you are beginning to find out that is possible not to get caught up in unpleasant experiences and to let them go.

How do I practice Mindfulness?

Mindfulness Meditation

Mindfulness meditation can be a good way of developing our mindfulness ability. Our minds are very busy and they will wander to thoughts about the past, worries about the future, to unpleasant feelings and sensations in our body. Each time this happens we try as best we can to notice where our mind has wandered to and then to gently bring our attention back to the practice. You are invited to engage in a mindfulness meditation practice with the daily practice on this site.

Bringing Mindfulness to Everyday Activities

You are invited to explore bringing mindfulness to everyday activities on the Everyday Mindfulness Activities page on this site. This might mean focusing on a task such as the washing up and really noticing what is happening for you in each moment. As your mind wanders to thoughts, feelings, images and so on, just notice where your mind has wandered to and gently bring your attention back to what is happening for you in the present moment.

Daily Mindfulness Practice

For the next several minutes, you're going to be asked to explore a particular kind of awareness called mindfulness in the form of a daily practice. We invite you to do this practice daily for the next two weeks, though you are more than welcome to do the practice more than daily if you wish. Research has shown that the more you practice the more likely you are to benefit.

The best way to understand mindfulness is to practice it repeatedly, so let's do that now. We have provided an audio guided practice for you to follow, lasting around 10 minutes. You can choose a male or female voice from the links below. We recommend you undertake the practice in a quiet, calm area or wear headphones.

TWO AUDIO FILES INSERTED HERE

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If you have any questions about any thoughts or experiences arising during the practice, please check out the Daily Practice FAQ page.

Everyday Mindfulness Activities

For the next two weeks, you are invited to practice bringing a particular kind of awareness called mindfulness to some of your daily activities. In the first week, we invite you to try bringing mindfulness to one routine activity. In the second week, we invite you to practice bringing mindfulness to a walk that you do regularly and to try bringing mindful awareness to pleasant moments in your day. You might also like to continue with the activity from week one, perhaps experimenting with a different routine activity.

Week One

Bringing awareness to routine activitiesA central tenet of mindfulness is learning how to bring awareness to everyday activities so that you can see life as it is, unfolding moment by moment. Mindfulness also involves not judging our experiences and cultivating an attitude of acceptance to whatever we notice.

Choose one of the following (or another of your own choosing), and each day for the next week, see if you can remember to pay non-judgmental attention while you are doing it. You do not have to slow it down, or even enjoy it. Simply do what you normally do, but see if you can be fully alive to it as you do.

• Brushing your teeth• Taking a shower• Drinking tea, coffee, juice• Taking out the rubbish• Loading the washing machine or tumble drier

Try this as an experiment with the same chosen activity each day for a week. The idea is not to make you feel different, but simply to allow a few more moments in the day when you are “awake”. Go at your own pace when doing your chosen activity, for example:

Brushing your teeth: where is your mind when you are brushing your teeth? Pay careful attention to all the sensations – the toothbrush in relation to the teeth, the flavour of the toothpaste, moisture building up in the mouth, all the movements required to spit, etc.

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Showering: pay attention to the sensations of the water on your body, the temperature, and the pressure. Notice the movements of the hand as you wash and the movements of the body as you turn and bend, etc. If you decide to take some of your showering time to plan or reflect, do so intentionally, with awareness that this is where you have decided to focus your attention.

Next week, feel free to continue this experiment with a different activity.

Week Two

Going for a walk

Over the next week, choose a five to thirty minute walk that you do regularly. The aim is to walk as mindfully as you can, focusing your awareness on your feet as they land on the ground, and feeling the fluid movement of all the muscles and tendons in your feet and legs. You might even notice that your whole body moves as you walk, not just your legs. Pay attention to all of the sights, sounds and smells. If you’re in a city you’ll see and hear a surprising number of birds and animals flapping and scurrying about. Notice how they react when they realise that you’ve seen them.

See if it’s possible to be open to all your senses: smell the scent of flowers, the aroma of cut grass, the mustiness of winter leaves or, perhaps, the smell of exhaust fumes and fast food; see if you can feel the breeze on your face or the rain on your head or hands; listen to the air as it moves; see how the patterns of light and shade can shift unexpectedly. Every moment of every season has a host of sensory delights – regardless of where you live.

Try stopping and looking upwards too. If you are in a city, you’ll be surprised by how many beautiful architectural features are just above natural eye level. You might also see tufts of grass or even trees growing out of roofs and guttering. If you are in a park or in the countryside, you’ll see all manner of things from birds’ nests to bees’ nests hidden in trees and bushes.

Appreciation here and now Happiness is looking at the same things with different eyes.Life only happens here – at this very moment. Tomorrow and yesterday are no more than a thought. So make the best of it. You do not know how long you have got. This is a positive message. It helps to give appreciative attention to what is here and now. How much appreciative attention do you have for the here and now? Become still and look around. How is the ‘now’ for you?

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We easily miss the beautiful things and give them little attention. Take time to pause for simple things, daily things. Maybe you can give a few of these activities or spontaneous events in your life extra attention.

Which activities, things or people in your life make you feel good? Can you give additional appreciative attention to these activities? Can you pause for a moment when pleasant moments occur?

Help yourself pause by noticing:• What body sensations you feel at these moments?• What thoughts are around?• What feelings are here?

These materials are taken and adapted from Williams, M., Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus

Daily Practice and Everyday Mindfulness Activities FAQ

As a result of the mindfulness meditation practice or of bringing mindfulness to everyday activities, you may experience a range of emotions and feelings, both good and bad. This FAQ page gives you some information as to how to deal with any of those feelings that arise.

I felt tense or restless - This is very common and not a problem. We’d encourage you to bring attention to the experience of tension or restlessness during the practice and, as best you can, greet that with gentleness and patience.

I felt my mind wandering away from the present moment - It is not a failure if our mind wanders. All of our minds wander; this is what minds do. Noticing our mind wandering is a valuable skill to develop. When we notice that our mind has wandered in the mindfulness practice, as best we can we acknowledge what the mind has wandered to, let go of any judgments about the fact the mind has wandered, and then gently bring our attention back to the present moment.

I think I haven’t done the practice well or can’t do the practice, or haven’t been very mindful of activities - It can be helpful to remind ourselves that we are not aiming for a particular state of mind when we practice mindfulness. Whatever we notice is a success. If we notice thoughts such as “I am not doing it right”, it is great that we have noticed them. Perhaps we can take a few moments to watch the effect these thoughts are having on our moment-by-moment experience, before returning to following the practice’s guidance.

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I felt I was daydreaming or getting lost in pleasant experiences - Many of us get lost in pleasant thoughts or daydreams from time to time. When we notice this has happened during practice, the invitation is to let go of these and to gently return to following the guidance in the practice.

Do I still need to record the duration and frequency of practice if I have not done any daily practice at all? – In the interests of data collection we would simply ask you to record a value of zero if you have not undertaken any mindfulness practice on a specific day.

I was feeling sleepy or falling asleep during the practice - Any of us can feel sleepy during mindfulness practice at times. Feeling sleepy during practice can be a really valuable opportunity to explore the present moment experience of feeling sleepy, including how the body feels when this happens. If you regularly feel sleepy during practice, you may want to reconsider the time of day that you practice and you may want to practice with your eyes open rather than closed. Sitting with an upright posture, with your back away from the chair if that is comfortable for you, can be helpful, as can practicing standing up.

I felt relaxed or calm - Feeling relaxed or calm can be a really interesting experience to explore and we’d encourage you to bring awareness to the body and to notice what body sensations come with feeling relaxed or calm, and whether there are any changes in these moment by moment.I felt focused or absorbed in the present moment - Sometimes when practicing mindfulness we can be very absorbed with our present moment experience and our minds may wander a little, which is great to notice. Also, it is important to remind ourselves that this experience is no better or worse than when the mind wanders, from the point of view of this practice.

During the practice or mindful activity, I felt irritated or disturbed by an experience (e.g. a noise, people talking, an unwanted thought or feeling, a pain in the body) - Very often there will be times in our experience while practicing mindfulness when feelings of frustration or irritation will arise. These are good opportunities to explore frustration and irritation in the present moment, including noticing what is happening in our body (e.g. maybe asking ourselves “where do I notice this most intensely in my body?”) and what is happening in our mind. Feelings of frustration and irritation can also be a valuable opportunity to practice inviting in the possibility of bringing patience and gentleness to our experience.

The practice or mindful activity made me feel more emotional or distressed - Because practicing mindfulness involves intentionally bringing our awareness to our experiences, whatever they may be, it is quite common to get in touch with feelings that can be upsetting. It is important to know that we have a choice at such times. One choice open

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to us is to explore this experience in the present moment, particularly noticing any bodily sensations that are occurring. Another choice that is open to us is to return attention to the breath.

If these feelings are persistent and overwhelming then please also remember that you are free to stop a practice and/or to end your participation in this study at any time. If you feel that you need help with these feelings then please see the list of contacts on the Help and Assistance page.

I'm doubting whether the practice or mindful activity will help me - If such thoughts we invite you to continue as best you can, acknowledging this doubt and maybe suspending your judgment until the end of the study.

I'm becoming aware of bodily sensation that I haven’t noticed before - It’s great that you are noticing more things about your experience. When we practice, it is not unusual to start to notice things that we were not previously aware of.

I find memories arising during the practice or mindful activity - It is very common to notice our minds wandering to memories. When you notice this has happened, we would invite you to acknowledge where your mind has wandered to and then gently bring your attention back to the present moment, as best you can.

Study Information

PROJECT TITLE: Meditation and Psychological Wellbeing Introduction

We are two trainee clinical psychologists currently undertaking the Clinical Psychology PsychD program at the University of Surrey.

We would like to invite you to take part in a research project. Before you decide you need to understand why the research is being done and what it will involve for you. Please take the time to read the following information carefully. Talk to others about the study if you wish.

What is the purpose of the study?

Meditation has been shown to have positive effects on psychological wellbeing and this study has been designed to find out whether a certain type of online meditation training will improve psychological wellbeing in people.

Why have I been invited to take part in the study?

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Students across campus have been invited to participate in the study. If you wish to continue, you need to give your informed consent on the online consent form below.

Do I have to take part?

If after reading this information sheet you decide not to take part, this is absolutely fine. If you decide to participate, you can withdraw from the study at any time without giving a reason, by emailing k.skerrett@surrey.ac.uk or robert.shore@surrey.ac.uk.

What will happen to me if I take part?

If you decided to take part in this study, you will be asked to complete a set of questionnaires relating to your psychological wellbeing. These will take about 40 minutes. Once you have completed the questionnaires, you will be allocated to one of three groups.

2/3 of people will be allocated to an online meditation program and 1/3 people will be allocated to the non-active control group. If you are allocated to the active group, you will be given access to the online meditation program within one week. If you are allocated to the control group, this means that you will not have access to the program until after you have completed the study.

The reason for having a control group is that this will allow us to compare the meditation groups to people who have had no meditation, to see if meditation is effective at helping people cope with stress. If allocated to the control group, your participation is just as important to the study. At the end of the study, after all measures have been completed, we will give all those allocated to the control group access to the meditation website.

After two weeks, we will ask you to repeat the measures that you completed at the beginning of the study. This is to see whether the online meditation program has had any effect on your psychological wellbeing. Participants in the control group will complete the same measures as the meditation group. These questionnaires will be repeated again at 1 week follow-up.

If you are allocated to a meditation group, you will be sent a link to the meditation website. You will be required to complete the ten minute meditation exercise on the website once per day for a two week period.

What will I have to do?

If you would like to take part in this study, or have any questions regarding the study, please let us know by emailing k.skerrett@surrey.ac.uk or rob.shore@surrey.ac.uk.

What are the possible disadvantages or risks of taking part?

It is not anticipated that the self-report measures or the meditation program will cause psychological distress. However, if you feel that some difficult issues have arisen for you, we recommend discussing this with the researchers who can give you information about student counselling services or recommend talking with your GP.

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What are the possible benefits of taking part?

Meditation is shown to have positive effects on mood and concentration, and to lower stress levels. You may benefit in this way if you are practice the meditation in the program.

What happens when the research study stops?

When the research study is over, you can continue to use the techniques that you have learnt. Due to the size of this study, we will not be able to give individual feedback to participants about our findings. However, we do plan to publish our findings in a peer-reviewed journal. If you would like to know the findings of our study once it is complete, please email the researchers.

What if there is a problem?

Any complaint or concern about any aspect of the way you have been dealt with during the course of the study will be addressed; please let us know by emailing k.skerrett@surrey.ac.uk or rob.shore@surrey.ac.uk. Will my taking part in the study be kept confidential?

Yes. All of the information you give will be anonymised so that those reading reports from the research will not know who has contributed to it.

Data will be stored securely in accordance with the Data Protection Act 1998.

However, should you disclose that you or someone else is at risk, then the researcher may need to report this to an appropriate authority. This would usually be discussed with you first.

Contact details of researchers:

Rob Shore r.shore@surrey.ac.ukKim Skerrett k.skerrett@surrey.ac.uk

Contact details of supervisors:

Clara Strauss c.strauss@surrey.ac.ukKate Gleeson k.gleeson@surrey.ac.uk

Who has reviewed the project?The study has been reviewed and received a favourable opinion from the University of Surrey Ethics Committee.

Thank you for taking the time to read this Information Sheet.

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Help and Assistance

If you have any questions regarding the study, please do not hesitate to contact the researchers by emailing

Rob Shore r.shore@surrey.ac.ukKim Skerrett k.skerrett@surrey.ac.uk

If you are feeling distressed you may find the following websites helpful.

Mind: http://www.mind.org.uk/

Samaritans: http://www.samaritans.org/

NHS Direct - http://www.nhsdirect.nhs.uk/ (Tel 0845 4647)

NHS Choices http://www.nhs.uk/Pages/HomePage.aspx

Alternatively, you may want to consult your GP for further guidance and support.

If you are a student of the University of Surrey, you may wish to contact the

University of Surrey Centre for Wellbeing:

http://portal.surrey.ac.uk/portal/page?_pageid=729,1&_dad=portal&_schema=PORTAL

(Tel: 01483 68 9498, email: centreforwellbeing@surrey.ac.uk )

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Appendix B. Outcome measures used in wider study

Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec 1990)

The Ruminative Responses Scale (RRS; Brooding items only) of the Response Styles Questionnaire (RSQ; Nolen-Hoeksema, 1991)

Rumination-Reflection Questionnaire (Trapnell & Campbell, 1999)

Depression, Anxiety and Stress Scale (Lovibond, & Lovibond, 1995).

PHQ-4 (Kroenke, Spitzer, Williams & Löwe, 2009). An Ultra-Brief Screening Scale for Anxiety and Depression: the PHQ-4.

The Short Warwick-Edinburgh Mental Wellbeing Scale (Stewart-Brown, Tennant, Tennant, Platt, Parkinson & Weich, 2009).

Self Compassion Scale (short form) (Raes, Pommier, Neff & Van Gucht, 2011)

References

Kroenke, K., Spitzer, R. L., Williams, J. B., & Löwe, B. (2009). An ultra-brief screening scale for anxiety and depression: the PHQ–4. Psychosomatics, 50(6), 613-621.

Lovibond, S. H., & Lovibond, P. F. (1995). Manual for the depression anxiety stress scales. Sydney: Psychology Foundation.

Meyer, T. J., Miller, M. L., Metzger, R. L., & Borkovec, T. D. (1990). Development and validation of the penn state worry questionnaire. Behaviour Research and Therapy, 28(6), 487-495.

Nolen-Hoeksema, S. (1991). Responses to depression and their effects on the duration of depressive episodes. Journal of Abnormal Psychology, 100, 569-582.

Raes, F., Pommier, E., Neff, K. D., & Van Gucht, D. (2011). Construction and factorial validation of a short form of the self‐compassion scale. Clinical psychology & psychotherapy, 18(3), 250-255.

Stewart-Brown, S., Tennant, A., Tennant, R., Platt, S., Parkinson, J., & Weich, S. (2009). Internal construct validity of the Warwick-Edinburgh mental well-being scale (WEMWBS): a Rasch analysis using data from the Scottish health education population survey. Health and Quality of Life Outcomes, 7(1), 15-22.

Trapnell, P.D., and Campbell, J.D. (1999). Private Self-Consciousness and the Five-Factor Model of Personality: Distinguishing Rumination from Reflection. Journal of Personality and Social Psychology, 76, 284-384.

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Appendix C. Five Facet Mindfulness Questionnaire

Five Facet Mindfulness Questionnaire Description:

This instrument is based on a factor analytic study of five independently developed mindfulness questionnaires. The analysis yielded five factors that appear to represent elements of mindfulness as it is currently conceptualized. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. More information is available in:

Please rate each of the following statements using the scale provided. Write the number in the blank that best describes your own opinion of what is generally true for you.

1 2 3 4 5 never or very rarely sometimes often very often or rarely true true true true always true

_____ 1. When I’m walking, I deliberately notice the sensations of my body moving.

_____ 2. I’m good at finding words to describe my feelings.

_____ 3. I criticize myself for having irrational or inappropriate emotions.

_____ 4. I perceive my feelings and emotions without having to react to them.

_____ 5. When I do things, my mind wanders off and I’m easily distracted.

_____ 6. When I take a shower or bath, I stay alert to the sensations of water on my

body.

_____ 7. I can easily put my beliefs, opinions, and expectations into words.

_____ 8. I don’t pay attention to what I’m doing because I’m daydreaming, worrying, or

otherwise distracted.

_____ 9. I watch my feelings without getting lost in them.

_____ 10. I tell myself I shouldn’t be feeling the way I’m feeling.

_____ 11. I notice how foods and drinks affect my thoughts, bodily sensations, and

emotions.

_____ 12. It’s hard for me to find the words to describe what I’m thinking.

_____ 13. I am easily distracted.

_____ 14. I believe some of my thoughts are abnormal or bad and I shouldn’t think that

way.

_____ 15. I pay attention to sensations, such as the wind in my hair or sun on my face.

_____ 16. I have trouble thinking of the right words to express how I feel about things

_____ 17. I make judgments about whether my thoughts are good or bad.

_____ 18. I find it difficult to stay focused on what’s happening in the present.

_____ 19. When I have distressing thoughts or images, I “step back” and am aware of the

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thought or image without getting taken over by it.

_____ 20. I pay attention to sounds, such as clocks ticking, birds chirping, or cars

passing.

_____ 21. In difficult situations, I can pause without immediately reacting.

_____ 22. When I have a sensation in my body, it’s difficult for me to describe it because

I can’t find the right words.

_____ 23. It seems I am “running on automatic” without much awareness of what I’m

doing.

_____24. When I have distressing thoughts or images, I feel calm soon after.

_____ 25. I tell myself that I shouldn’t be thinking the way I’m thinking.

_____ 26. I notice the smells and aromas of things.

_____ 27. Even when I’m feeling terribly upset, I can find a way to put it into words.

_____ 28. I rush through activities without being really attentive to them.

_____ 29. When I have distressing thoughts or images I am able just to notice them

without reacting.

_____ 30. I think some of my emotions are bad or inappropriate and I shouldn’t feel

them.

_____ 31. I notice visual elements in art or nature, such as colors, shapes, textures, or

patterns of light and shadow.

_____ 32. My natural tendency is to put my experiences into words.

_____ 33. When I have distressing thoughts or images, I just notice them and let them go.

_____ 34. I do jobs or tasks automatically without being aware of what I’m doing.

_____ 35. When I have distressing thoughts or images, I judge myself as good or bad,

depending what the thought/image is about.

_____ 36. I pay attention to how my emotions affect my thoughts and behavior.

_____ 37. I can usually describe how I feel at the moment in considerable detail.

_____ 38. I find myself doing things without paying attention.

_____ 39. I disapprove of myself when I have irrational ideas.

Scoring Information: Observe items: 1, 6, 11, 15, 20, 26, 31, 36 Describe items: 2, 7, 12R, 16R, 22R, 27, 32, 37 Act with Awareness items: 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R Nonjudge items: 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R Nonreact items:

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4, 9, 19, 21, 24, 29, 33

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Appendix D. Paranoia scale

Please read each statement and tick the box that indicates how applicable each statement is to you. As before, it is usually your initial response that is most accurate so please do not spend a long time considering each item.

Not

at a

ll ap

plic

able

to m

e.

Slig

htly

ap

plic

able

to m

e.

Mod

erat

ely

appl

icab

le to

me.

Ver

y ap

plic

able

to

me.

Ext

rem

ely

appl

icab

le to

me.

1. Someone has it in for me

2. I sometimes feel as if I am being followed

3. I believe that I have often been punished without cause

4. Some people have tried to steal my ideas and take credit for them.

5. My parents and family find more faults with me than they should.

6. No one really cares much about what happens to you.

7. I am sure I get a raw deal in life.

8. Some people will use somewhat unfair means to get profit or an advantage, rather than lose it.

9. I often wonder what hidden reason another person may have for doing something nice for you.

10. It is safer to trust no one.

11. I have often felt that strangers were looking at me critically.

12. Most people make friends because friends are likely to be useful to them.

13. Someone has been trying to influence my mind.

14. I am sure I have been talked about behind my back.

15. Most people inwardly dislike putting themselves out to help other people.

16. I tend to be on my guard with people who are somewhat more friendly than I expected.

17. People have said insulting and unkind things about me.

18. People often disappoint me.

19. I am bothered by people outside, in cars, in stores, etc watching me.

20. I have often found people jealous of my good ideas just because they had not thought of them first.

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Appendix E. Participant Engagement Questionnaire

Please answer the following questions about your engagement with the course:

How much time over the past week in total have you spent engaging with the course materials (not including time spent engaging in meditation practices)?

hours …………..

minutes………….

On how many days over the past week have you spent time engaging with the course materials (not including time spent engaging in meditation practices)?

0 1 2 3 4 5 6 7

How much time in total over the past week have you spent listening to the meditation audio recordings and engaging in meditation practices?

hours …………..

minutes………….

On how many days over the past week have you spent time listening to the meditation audio recordings and engaging in meditation practices?

0 1 2 3 4 5 6 7

How much do you really feel this intervention is helping your wellbeing?

Where 1 = not at all and 9 = very much.

1 2 3 4 5 6 7 8 9

Thank you for completing these questions, please continue with the meditation course until the end of the study.

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Appendix F. Ethics committee approval

Chair’s Action

Proposal Ref: 980-PSY-14

Name of Student/Trainee:

ROBERT SHORE

Title of Project: A randomised controlled trial of mindfulness-based therapy for worry, rumination and paranoia with a non-clinical population

Supervisor: Dr Kate Gleeson

Date of submission:

Date of confirmation email:

21st January 2014

27th February 2014

The above Research Project has been submitted to the FAHS Ethics Committee and has received a favourable ethical opinion from the Faculty of Arts and Human Sciences Ethics Committee with conditions. The conditions stipulated after ethical review have now been addressed and the relevant amended documents submitted as evidence prior to commencement of your study.

The final list of documents reviewed by the Committee is as follows:Protocol Cover sheet Summary of the projectDetailed protocol for the projectParticipant Information sheetConsent Form

This documentation should be retained by the student/trainee in case this project is audited by the Faculty Ethics Committee.

Signed: _________________ Dated: Professor Bertram OpitzChair

Please note:If there are any significant changes to your proposal which require further scrutiny, please contact the Faculty Ethics Committee before proceeding with your Project.

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Appendix G. Study poster

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Meditation OnlineAre you interested in learning meditation techniques that will help you to manage stress and improve your psychological

wellbeing?We are doing a research project to see if learning meditation online can improve wellbeing.

The online program lasts two weeks. During this time you can access it whenever you like, from the comfort of your own home.

This study is being conducted by Robert Shore and Kim Skerrett as part of the PsychD program in Clinical Psychology at The University of Surrey.

If you have any questions, please contact:

Robert: robert.shore@surrey.ac.uk / 07814962902 orKim: k.skerrett@surrey.ac.uk / 07834439513

The main supervisor for this study is Dr Kate Gleeson who can be contacted by email: kate.gleeson@surrey.ac.uk

This study has received a favourable opinion from the Faculty of Arts & Human Sciences Ethics Committee.

To take part, go to:

http://surveys.fahs.surrey.ac.uk/Learning_Meditation_Online

Appendix H. Study flyer

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Meditation OnlineAre you interested in learning meditation

techniques that will help you to manage stress and

improve your psychological wellbeing?We are doing a research project to see if learning meditation online can improve wellbeing.

The online program lasts two weeks. During this time you can access it whenever you like, from the comfort of your own home.

To take part, go to:

http://surveys.fahs.surrey.ac.uk/Learning_Meditation_Online

This study has received a favourable opinion from the Faculty of Arts & Human Sciences Ethics Committee.

This study is being conducted as part of the PsychD program in Clinical Psychology at The University of Surrey. The main supervisor for this study is Dr Kate Gleeson

). If you have any questions, please contact the researchers:

Appendix I. Social media post

Help me out with my research! We are looking for people to take part in our research study into the effects of meditation on psychological well-being. It's part of our Clinical Psychology Doctorate at Surrey University.

We'll ask you to practice meditation 10 mins a day for two weeks, as well as completing questionnaires before, after and at one-week follow up.

For more information and to take part, go to:

http://surveys.fahs.surrey.ac.uk/Learning_Meditation_Online

***PLEASE SHARE THIS WITH YOUR FRIENDS!!***

Thank you 

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Appendix J. Scatterplots of variables

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Appendix K. Histograms of residuals

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School of Psychology Coursework Form

PsychD Clinical Psychology

Major Research Project Proposal Form

Project Title: A randomised controlled trial of the impact of an online MBT course on paranoid thoughts in a non-clinical population

Student URN: 6242539

Year 2

November 2013

Word Count: 2907

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Introduction

Mindfulness originated in the principles and traditions of Buddhist meditation practices and

involves cultivating aspects of awareness, insight and compassion (Kabat-Zinn, 2000). There

are many mindfulness exercises that help to cultivate non-judgemental awareness and a range

of therapies such as Mindfulness Based Stress Reduction, Mindfulness Based Cognitive

Therapy, and Acceptance and Commitment Therapy that use these exercises to some extent.

It is proposed that by engaging in mindfulness exercises people can develop the skills and

mental framework to attend to more experiences in a mindful way (Kabat-Zinn, 2003).

Mindfulness-based interventions (MBI) can be delivered to groups, individually or via self-

help methods such as online courses. Online courses are a relatively novel way to deliver

MBI and at present there is not much research on their efficacy. However Cavanagh et al.

(2013) used a two week online MBI course in a study involving a non-clinical sample of 104

students. They found significant improvements on measures of mindfulness, perceived stress,

anxiety and depression following the intervention but not following the waitlist control

condition with effect sizes ranging from d = 0.41 to d = 0.62.

In theory, mindfulness can reduce the distress associated with negative experiences by giving

people the skills to relate and respond differently to their experiences using observation and

acceptance. This is based on the concept that distress is mediated by how an individual relates

to their experiences rather than being directly caused by those experiences (Abba, Chadwick

& Stevenson, 2008). Distressing experiences that relate to psychotic symptoms such as

distressing voices, delusions and paranoid thinking can cause people to react with avoidance

strategies or rumination and confrontation with paranoid thoughts (Jacobson et al, 2010).

Chadwick et al. (2005) proposed a model for how mindfulness could reduce psychosis related

distress by providing an alternative way to relate to psychotic sensations (see Figure 1).

Through the practice of letting go of reactions such as self-judgement and rumination on

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paranoid thoughts, individuals can begin to observe and accept psychotic experience and

therefore reduce the distress related to that experience. (Chadwick et al., 2009).

Figure 1. An alternative way to respond to psychotic sensations (Chadwick et al., 2005)

MBI for psychological problems relating to psychosis are becoming more common in clinical

practice. There is emerging evidence for the use of MBI for psychosis however at present the

evidence is not conclusive. A systematic search of studies evaluating MBI for psychosis

identified sixteen studies published in peer reviewed journals (Appendix F). All studies

reviewed had to include mindfulness practice however there was heterogeneity in the

interventions used with studies varying with regard to the type and length of exercise, number

of sessions and their use of group or individual delivery.

There were eight quantitative studies included in the review. Four of those studies did not

employ a control condition and found statistically significant pre-post change on some of

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Psychotic sensation(paranoid thoughts, voices, images)

Mindful Response Distressing Reaction

Experiential Avoidance

Rumination, confrontation

Acceptance

Non-judging

Letting Go

JudgementClear awar

Lost in reaction

their primary measures such as general wellbeing. However these studies were unable to

discount extraneous factors from mediating change. The absence of a control group limits

potential conclusions because any changes might have occurred with no intervention. The

quantitative studies that did have a control comparison generally failed to gain significant

between-group results. However, the controlled trials were underpowered to find anything

other than a large effect size and so do not allow us to draw strong conclusions about the

effectiveness of mindfulness-based interventions for psychosis. These findings give the

overall picture that at present there is a lack of evidence from high quality studies for the

effectiveness of MBI for distress related to psychosis.

The review of the literature highlighted a shortage of research into the impact of mindfulness

on specific experiences related to psychosis. Although there some are studies specifically

looking at voice hearing (Dannahy et al, 2011; May et al, 2012; Goodliffe et al, 2010) and

paranoia (Ellett, 2013), the majority of studies reviewed included participants with any

schizophrenia-related diagnoses. The assumption of these studies is that all psychosis-related

symptoms will be affected by mindfulness in the same way; however it is possible that people

who have different psychosis-related presentations will respond differently to mindfulness.

There is a need for further research investigating whether mindfulness is effective for certain

presentations or aspects of the psychotic experience such as paranoia.

Paranoia is a feature of human experience that is present and can be studied in clinical and

nonclinical samples (Freeman et al. 2011). Furthermore, studies have indicated that paranoia

has implications for the general population with regard to their health, emotional well-being

and social functioning and have shown nonclinical paranoia to be distressing in the

nonclinical population (Freeman et al. 2011, Ellett et al, 2003). Freeman et al. (2005)

proposed that paranoia can be viewed in clinical and nonclinical populations as a multi-

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dimensional experience with distress, belief conviction and frequency of paranoid thoughts

being identified as separate dimensions.

Ellett (2013) presented evidence from two case studies investigating the impact of

mindfulness for paranoia. The results show reductions in paranoid beliefs however it is not

possible to fully establish whether these are mediated by mindfulness or other extraneous

factors. At present there is no research investigating the impact of mindfulness on paranoia in

non-clinical populations. The proposed study aims to investigate these gaps in the literature

by running an adequately powered randomised controlled trial comparing a brief online MBI

with a waitlist control condition to assess the impact of MBI on the on the distress, belief

conviction and frequency of paranoid thoughts in a non-clinical population.

Research Question

Does brief online MBI reduce the distress, belief conviction and frequency of paranoid

thoughts when compared to no intervention and do mindfulness skills mediate the

relationship between MBI and reductions in paranoid thoughts?

Main Hypotheses

This study aims to test whether brief online MBI will lead to greater reductions in

paranoia than no intervention. To this end, this study will test the mediation model shown in

Figure 2 which hypothesises that increased mindfulness skills will mediate the relationship

between the intervention condition and changes in paranoia. Following from this mediation

hypothesis, the main hypotheses for this study are:

1. Participation in an online MBI will lead to significantly greater reductions in the

distress, belief conviction and frequency of paranoid thoughts in comparison to waitlist

control

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2. Participation in an online MBI will lead to significant improvements in mindfulness

skills in comparison to waitlist control

3. Improved mindfulness skills will mediate the relationship between the MBI condition

and reductions in paranoia

Improved mindfulness skills

MBT reduced paranoia

(distress, frequency, conviction)

Figure 2. Proposed mediation model

Method

This study is part of a larger study with a larger research team (Appendix E) exploring the

effects of MBI on a variety of outcomes. Other members of the research team are involved in

the design of the study. I will describe the aspects of the larger study that are relevant my

research question.

Participants

This is a three arm study with two main researchers focussing on different control conditions,

therefore participants will have to be recruited to three conditions however each researcher

will only have to recruit half the participants for the study. Previous research using online

MBI have found effect sizes ranging from d = 0.41 to d = 0.62 (Cavanagh et al., 2013).

Taking this into account, using a repeated measures design with three groups and three time

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points, a priori power calculation using G*Power (Faul et al., 2009) indicates a minimum

sample size of 108 participants with an actual power of 80% (p = 0.05, f = 0.25). With the

potential for high attrition rates in online MBT (approximately 50%; Cavanagh et al., 2013)

this study will aim to recruit 216 participants with 72 in each condition to allow for a 50%

drop-out rate.

The sample will be taken from a non-clinical population of university students at the

University of Surrey and Royal Holloway University. The study will be advertised at the

universities and the potential pool of participants is about 24,000 students. All participants

must be English speaking students and can be undergraduate or post-graduate, full time or

part time. Participants must not have had previous experience of MBI and must not be

presently receiving psychological therapy to allow the impact of mindfulness to be

specifically measured.

Intervention

For this study a two week online MBI will be used. The rationale for using brief online MBI

is that they have been shown to be effective on measures of mindfulness, perceived stress,

anxiety and depression (Cavanagh et al., 2013) but at present there is no research about their

impact on paranoia. The online intervention contains information about mindfulness and

audio-based practices to follow. Participants are invited to listen daily to a 10 minute

mindfulness exercise that is adapted from Chadwick (2006). The online program also

contains a mindfulness FAQ section and a daily journal for participants to reflect on their

experiences. As part of the intervention standardised emails are sent out at three day intervals

to invite participants to continue their daily practice.

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Measures

The full study will use a wide set of measures1 however I will describe the subset of measures

relevant to my research question. The wider set of measures totals 231 items and is similar to

the number used by Cavanagh et al. (2013).

The Paranoia Scale (Fenigstein and Vanable, 1992)

The Paranoia Scale (Appendix B) has twenty items with each item rated on a five point scale.

It was developed to measure paranoia in college students and is a widely used measure of

paranoia and therefore will allow comparisons with other paranoia research. It has

demonstrated good internal reliability (Cronbachs alpha =0.84) and good test re-test

reliability (r=0.70). Construct validity has been evidenced by its association with a

behavioural criterion of paranoia and moderate levels of shared variance with other

psychological variables associated with paranoid symptomology. In a sample of college

students the mean total score on the paranoia scale (on a range of 20-100) was 42.7 (standard

deviation [SD]=10.2). There was sufficient variation in scores for the scale to be considered

suitable for use with a college population.

The Paranoia Checklist (Freeman et al. 2005)

The Paranoia Checklist (Appendix C) is an 18 item questionnaire with each item rated on a

five point scale for frequency, belief conviction and distress related to paranoia. It aims to

provide a multi-dimensional assessment of paranoia. The scale demonstrated good internal

reliability for each of the three dimensions (Cronbachs alpha > 0.9) and convergent validity

with the paranoia scale (r=0.58-0.71). In a non-clinical population the mean scores for each

1 Other measures: Penn State Worry Questionnaire; Ruminative Responses Scale (Brooding items only); Rumination-Reflection Questionnaire; Depression, Anxiety and Stress Scale; The Short Warwick-Edinburgh Mental Wellbeing Scale; Self Compassion Scale (short form); OBQ 44.

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dimension out of 90 were: frequency =11.9 (SD=10.5, range 0–64); conviction =16.7

(SD=12.1, range 0–72); distress 14.6 (SD=12.2, range 0–70).

Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006)

The FFMQ (Appendix D) has 39 items with each item rated on a five point scale. It identifies

five independent facets of mindfulness and therefore allows investigation into which aspects

of mindfulness might be mediating improvements in paranoia. Furthermore, it has been used

widely in other evaluations of MBI and will allow comparison of effect sizes with other

studies. The scale has demonstrated adequate to good internal consistency for all five facets

(Cronbachs alpha =0.75–0.91).

Design

This is a quantitative study with random assignment to experimental treatment

condition (MBI) and no intervention control condition. Repeated measures are to be taken at

baseline, end of therapy and at follow-up one week after therapy for each condition. All

participant involvement will be through a computer with the MBT condition being a two

week online MBI course and questionnaire administration being online at each time point.

This will allow me to remain blind to group allocation.

Procedure

Once the MRP proposal is agreed application will be made to the University ethics committee

to get approval to run the study with students at the university. Following ethics approval

posters and flyers will be displayed around the university to advertise the study.

Opportunities to speak to students at the end of lectures and give out flyers at the end of

lectures will be pursued. Also the University of Surrey Research Participation System will be

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used to access students that have given permission to be contacted regarding participation in

studies at the university.

As participants are recruited they will be randomly assigned to one of the two conditions

using a block randomisation program and randomisation will be conducted by someone

independent to the research team. Questionnaires will be completed by participants online at

baseline, post-intervention and at follow-up one week after completing the intervention. Data

from the online questionnaires will be downloaded for analysis.

Ethical considerations (University of Surrey Ethics Committee)

Paranoia is a normal social process that is present in the general population and the

measures used in this study are not diagnostic instruments. Participants will not be given

feedback on any of the questionnaires administered, nevertheless, should a participant

express a concern about their mental health or about their responses to the questionnaires then

they would be thanked for letting us know, their experiences would be normalised and

contact details for a range of sources of support would be provided. Support would not be

given by ourselves as we are a research team and not providing a clinical service. The

participant information sheet and debrief sheet will suggest that any concerns about responses

to any of the questions could be discussed with their GP, the wellbeing centre or a telephone

service such as the Mind support line.

Due to there being an inactive control group, it will have to be made clear to

participants signing up for the study that they may not receive an intervention. Furthermore,

all advertising for the study must make this explicit. Participants who are assigned to the

control condition will gain access to the online mindfulness intervention once the study is

completed.

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R&D Considerations

The NHS is not involved in this study because it will be using a non-clinical sample of

university students from the University of Surrey.

Proposed Data Analysis

Comparisons will be made of means and standard deviations at baseline to check for

differences between groups prior to treatment in order to check randomisation. All data will

be checked for its distribution and outliers will be identified and removed/replaced. Means

and standard deviations for each variable within each condition at each time point will be

presented.

The primary analysis will investigate differences between the intervention and control groups

at the end of the intervention period using 2 (group) x 3 (time) repeated measures analyses of

variance for each measure in the study. Multiple Imputation (Rubin, 1987) will be used to

manage missing data by replacing every missing value with a set of plausible values. This

will allow valid statistical inferences to be made that reflect the uncertainty associated with

missing values.

If significant differences are found in the primary analysis then the mediation model (Figure

1) will be tested through multiple regression using the SPSS INDIRECT macro from

Preacher and Hayes (2008). MBT will be compared to no-intervention for each of the

paranoia subscales. The independent variable (X) will be the experimental condition (MBT

versus no-intervention), the mediator (M) will be change in mindfulness skills and the

dependent variable (Y) will be change in paranoia (distress/frequency/conviction).

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Service User and Carer Consultation / Involvement

I gained feedback from the service User / carer representative during my research proposal

presentation. This highlighted potential issues of participant’s perception of mindfulness and

how that might impact recruitment. This information was used to help form recruitment

strategies that may reduce this impact.

Students are the recruitment population for this study and therefore consultation will be made

with students regarding number of outcome measures, recruitment materials and recruitment

strategy. If the number of outcome measures is deemed too large then we will look at

reducing the number of measures.

Feasibility Issues

A potential issue with this study is not recruiting enough participants. It is an essential

element of this study that a large enough sample is recruited to avoid the potential issue of the

study being underpowered. To avoid this advertising and recruitment will have to be

extensive and thorough. Also, being able to recruit participants from Royal Holloway

University and the University of Surrey means that there is a relatively large pool of

participants to recruit from. With an online MBT intervention, signing up to the study only

involves spending time on a computer making it relatively easy to participate in the study. As

recruitment will only involve replying to emails and signing participants up online this will

be possible throughout the week. Furthermore data could be collected throughout the whole

of 2014 to maximise time available to recruit participants.

High drop-out rates will be a potential issue in this study. With an online study there is likely

to be a high attrition rate because the study is very easy to disengage from. Cavanagh et al.

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(2013) experienced an attrition rate of 47.7% with this intervention in a student population.

Therefore the recruitment target will build in an expected drop out of 50%.

Dissemination strategy

Once completed will be written up for publication in a peer reviewed journal. Findings will

also be disseminated amongst peers at a relevant conference.

References

Abba, N., Chadwick, P., & Stevenson, C. (2008). Responding mindfully to distressing psychosis: A grounded theory analysis. Psychotherapy Research, 18, 77-87.

Baer, R. A. (2003). Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical Psychology: Science and Practice, 10, 125–143.

Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., & Toney, L. (2006). Using self- report assessment methods to explore facets of mindfulness. Assessment, 13, 27-45.

Carmody, J., & Baer, R. A. (2009). How long does a mindfulness‐based stress reduction program need to be? A review of class contact hours and effect sizes for psychological distress. Journal of clinical psychology, 65(6), 627-638.

Cavanagh, K., Strauss, C., Cicconi, F., Griffiths, N., Wyper, A., & Jones, F. (2013). A randomised controlled trial of a brief online mindfulness-based intervention. Behaviour Research and Therapy, 51, 573-578.

Chadwick, P. (2006). Person-Based Cognitive Therapy for distressing psychosis. Chichester: Wiley.

Chadwick, P., Hughes, S., Russell, D., Russell, I., & Dagnan, D. (2009). Mindfulness groups for distressing voices and paranoia: A replication and randomized feasibility trial. Behavioural and Cognitive Psychotherapy, 37(4), 403-412.

Chadwick, P., Taylor, K. N., & Abba, N. (2005). Mindfulness groups for people with psychosis. Behavioural and Cognitive Psychotherapy, 33(3), 351-359.

Dannahy, L., Hayward, M., Strauss, C., Turton, W., Harding, E., & Chadwick, P. (2011). Group person-based cognitive therapy for distressing voices: Pilot data from nine groups. Journal of Behavior Therapy and Experimental Psychiatry, 42(1), 111-116.

Ellett, L., Lopes, B., & Chadwick, P. (2003). Paranoia in a nonclinical population of college students. The Journal of nervous and mental disease, 191(7), 425-430.

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Ellett, L. (2013). Mindfulness for Paranoid Beliefs: Evidence from two case studies. Behavioural and cognitive psychotherapy, 41(02), 238-242.

Fenigstein, A., & Vanable, P. (1992). Persecutory ideation and self consciousness. Journal of Personality and Social Psychology, 62, 129-138.

Freeman, D., Garety, P., Bebbington, P., Smith, B., Rollinson, R., Fowler, D., Kuipers, E., Ray, K., & Dunn, G. (2005). Psychological investigation of the structure of paranoia in a non-clinical population. British journal of psychiatry, 186 , 427-435.

Freeman, D., McManus, S., Brugha, T., Meltzer, H., Jenkins, R., & Bebbington, P. (2011). Concomitants of paranoia in the general population. Psychological Medicine, 41, 923-926.

Fritz, M.S., & MacKinnon, D.P. (2007). Required sample size to detect the mediated effect. Psychological Science 18, 233-239.

Faul, F., Erdfelder, E., Buchner, A., & Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 1149-1160.

Goodliffe, L., Hayward, M., Brown, D., Turton, W., & Dannahy, L. (2010). Group person-based cognitive therapy for distressing voices: Views from the hearers. Psychotherapy Research, 20(4), 447-461.

Grossman, P., Niemann, L., Schmidt, S., & Walach, H. (2004). Mindfulness-based stress reduction and health benefits: A meta-analysis. Journal of psychosomatic research, 57(1), 35-43.

Harnett, P. H., Whittingham, K., Puhakka, E., Hodges, J., Spry, C., & Dob, R. (2010). The short-term impact of a brief group-based mindfulness therapy program on depression and life satisfaction. Mindfulness, 1, 183-188

Jacobson, P., Morris, E., & Johns, L. (2010). Mindfulness groups for psychosis: Key issues for implementation on an inpatient unit. Behavioural and Cognitive Therapy, 39, 349-353.

Jain, S., Shapiro, S. L., Swanick, S., Roesch, S. C., Mills, P. J., Bell, I., & Schwartz, G. E. R. (2007). A randomized controlled trial of mindfulness meditation versus relaxation training: Effects on distress, positive states of mind, rumination, and distraction. Annals of Behavioral Medicine, 33, 11-21.

Kabat-Zinn, J. (1990). Full Catastrophe Living: the program of the Stress Reduction Clinic at the University of Massachusetts Medical Centre. New York: Dell.

Kabat-Zinn, J. (2000). Indra’s net at work: The mainstreaming of Dharma practice in society. In G. Watson & S. Batchelor (Eds.), The psychology of awakening: Buddhism, science, and our day-to-day lives (pp. 225–249). Nork Beach, ME:Weiser.

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Kabat-Zinn, J. (2003). Mindfulness-based interventions in context: Past, present, and future. Clinical Psychology: Science and Practice, 10(2), 144.

Kingston, J., Chadwick, P., Meron, D., & Skinner, T. C. (2007). A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. Journal of psychosomatic research, 62(3), 297-300.

May, K., Strauss, C., Coyle, A., & Hayward, M. (2012). Person-based cognitive therapy groups for distressing voices: A thematic analysis of participant experiences of the therapy. Psychosis, (ahead-of-print), 1-11.

Preacher, K. J., & Hayes, A. F. (2008). Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behavior research methods, 40(3), 879-891.

Rubin, D.B. (1987), Multiple Imputation for Nonresponse in Surveys, New York: John Wiley & Sons, Inc.

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School of Psychology Coursework Form

PSYCHD CLINICAL PSYCHOLOGY

Major Research Project Literature Review

Year 1

2013

Assignment Title: Mindfulness-based treatment for

psychosis: A Literature Review of Effectiveness

Student URN: 6242539

Word Count: 8000 words max

This literature review is targeted at the Clinical Psychology Review journal

because it is a significant and novel evaluation of the literature on

Mindfulness-based treatment for psychosis. Research in this area is

continually growing and treatments are becoming more prevalent in clinical

practice therefore it is important that a thorough review of the current state

of research is published in a high impact journal such as the Clinical

Psychology Review to provide maximum exposure to practicing clinicians

and researchers.

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Abstract

The practice of mindfulness as a clinical therapeutic intervention has

been increasing and there are now a range of interventions which involve

mindfulness practice in their protocol. There is some evidence supporting

the use of mindfulness-based interventions for depression, generalised

anxiety, and chronic pain. However, the use of mindfulness for symptoms

related to psychosis has raised concerns regarding the potential harm

meditative practice can have on this population. This paper reviews the

literature on mindfulness-based interventions for psychosis. Findings are

that despite concerns about safety there is growing evidence that appropriate

mindfulness-based interventions do not have a negative impact on people

with psychosis. Furthermore, an evidence base is emerging that indicates

mindfulness practice can be beneficial, improving outcomes on certain

aspects of the psychotic experience. Qualitative research has indicated

potential mechanisms of change and highlighted perceived benefits for the

individual without necessarily evidencing clinical improvement. Evidence

from case studies and non-controlled studies indicate potential

improvements in clinical measures of mindfulness and general wellbeing.

However, thus far, underpowered controlled trials have failed to find

significant changes in primary outcome measures. This exposes the need for

adequately powered studies with larger sample sizes using active and

inactive control groups to better understand the impact and effectiveness of

mindfulness practice. This review highlights the need for qualitative

research that is conducted entirely independently from the research team and

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further research into the impact mindfulness has on different aspects of the

psychotic experience.

1. Introduction

The concept of mindfulness originated in and tends to be associated with

Buddhism. The use of mindfulness practice as a therapeutic intervention in a

clinical setting has been evolving and is now relatively common.

Mindfulness aims to help people be aware of their thoughts, feelings and

sensations whilst suspending judgment. It is thought that mindfulness can

alleviate distress by allowing people to relate differently to their

experiences. There are a range of interventions that now utilise mindfulness

practice to make positive change. Evidence for the efficacy of these

interventions for clinical presentations such as depression is relatively good.

There have been concerns about the use of mindfulness for people with

psychosis due to the potential harm that meditative practice can cause with

this population. Emerging evidence however indicates that appropriate

mindfulness interventions for people with symptoms of psychosis do not

have a negative impact and are potentially beneficial. The literature

regarding mindfulness for psychosis is increasing constantly and many

questions remain unanswered. For this reason it is important to gain a clear

and thorough understanding of the current evidence and highlight where

future research needs to focus.

The principles of mindfulness originate from Buddhist traditions and

meditation practices. Mindfulness practice involves cultivating aspects of

awareness, insight and compassion (Kabat-Zinn, 2000). A definition often

90

used by clinicians and researchers defines mindfulness as “the awareness

that emerges through paying attention on purpose, in the present moment,

and nonjudgmentally to the unfolding of experience moment by moment”

(Kabat-Zinn, 2003, p. 145). It is believed that this way of attending can be

cultivated using meditation practices and there are numerous mindfulness

exercises developed to encourage the use of mindfulness skills (Baer, 2003).

Although these exercises vary in their focus with some training attention on

external stimuli and others on internal experiences, their common principle

is to attend to the present in an accepting and non-judgemental manner. It is

suggested that by engaging in mindfulness exercises one can develop the

skills and mental framework to attend to more experiences in this specific

way (Kabat-Zinn, 2003).

The use of mindfulness as a therapeutic intervention is founded on the

concept that distress is caused by how an individual responds to experiences

rather than being directly caused by those experiences (Abba, Chadwick &

Stevenson, 2008). Therefore, by helping to relate and respond differently to

experiences, mindfulness can reduce the distress associated with those

experiences. The principle that distress results from the mind’s response to

events has parallels with cognitive therapy, the main distinction from

cognitive therapy being that mindfulness encourages observation and

acceptance of the mind’s responses rather than challenging and changing

them.

There are many mindfulness-based interventions; some use mindfulness

as the core element, such as Mindfulness-Based Stress Reduction (MBSR;

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Kabatt-Zinn, 1990), and Mindfulness-Based Cognitive Therapy (MBCT;

Segal, Williams and Teasdale, 2002); others incorporate mindfulness

practice and principles alongside other therapeutic approaches, such as

Person-Based Cognitive Therapy (PBCT; Chadwick 2006), and Acceptance

and Commitment Therapy (ACT; Hayes, Strosahl, and Wilson, 1999). A

review by Baer (2003) on studies involving MBSR and MBCT supported

the use of mindfulness-based interventions for depression, generalised

anxiety, chronic pain and other physical health problems. However a

systematic review of third wave treatments, most of which incorporate

mindfulness principles, found that none of the therapies they reviewed

fulfilled the criteria for empirically supported treatments (Ost, 2008).

The clinical use of mindfulness-based interventions for psychological

problems relating to psychosis such as distressing voices, delusions and

paranoid thinking is increasing. However at present mindfulness

interventions for these presentations has gained less support than for many

other mental and physical health problems. Indeed, it has been suggested

that meditative practice could have a negative impact on people vulnerable

to psychosis (Yorston, 2001) and support is especially weak for

mindfulness-based interventions for acute psychosis (Segal et al. 2002).

Despite concerns regarding mindfulness for psychosis, research into

ACT for psychosis has indicated potential benefits for this population (Bach

and Hayes, 2002). A recent review of mindfulness-based interventions for

serious mental illness found that this approach potentially produced a range

of benefits however conclusions were restricted by a lack of rigorously

92

controlled trials (Davis and Kurzban, 2012). This paper reviewed a wide

range of therapies with links to mindfulness including treatments without

significant mindfulness practice and therefore was unable to make

conclusions regarding the relative impact of mindfulness practice. This

highlights the need to improve understanding in this area by evaluating the

current literature on the effectiveness of treatments involving explicit

mindfulness practice.

It has been suggested that distressing psychotic symptoms often induce

avoidance strategies or rumination and confrontation in the individual

(Jacobson et al, 2010). Chadwick et al. (2005) proposed a model for how

mindfulness could reduce psychosis related distress by providing an

alternative way to relate to psychotic sensations. That is, increasing

awareness and acceptance of psychotic experiences and letting them pass

without judging rather than engaging in experiential avoidance, judging,

rumination and confrontation. It is proposed that in this way, mindfulness-

based interventions can reduce the subjective distress associated with

reacting to psychotic experiences.

The potential benefits theorised regarding mindfulness for psychotic

distress combined with emerging indications from research and practice that

it does not appear to have a negative impact on this population highlights

the importance of reviewing the literature to gain a clearer understanding.

Research on this subject is growing and evolving continually and at present

there is no up-to-date published review of mindfulness based interventions

that explicitly involve mindfulness practice for distress related to psychosis.

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For this reason this review aims to gain a comprehensive understanding of

the current evidence regarding the effectiveness of mindfulness-based

treatments for psychosis and highlight where future research needs to focus.

2. Method

A systematic examination of relevant literature was undertaken to

evaluate the potential effectiveness of mindfulness-based interventions for

people who have experienced psychotic symptoms. The intention of the

literature search was to identify all published studies involving mindfulness-

based interventions with people who have experienced symptoms linked to

psychosis.

A systematic search of electronic databases was completed on 18 th

December 2012 using the PsycInfo, Web of Knowledge and Scopus

databases. No initial search limits were used so that all relevant literature up

to the search date could be identified. The search terms used were:

(Mindfulness or MBCT or MBSR or “acceptance and commitment” or

“person based cognitive therapy”) AND (psychosis or paranoi* or voice* or

psychotic or schizophr* or schizoaff* or hallucin* or delusion*) in abstract

(Psychinfo) and title/abstract/keywords (Scopus and Web of Knowledge).

For studies to be included they had to meet the following criteria: (i)

explicit use of mindfulness practice by participants in the study to make sure

mindfulness practice and not just theory was being evaluated2; (ii) published

in peer reviewed journals to ensure the quality of articles used in the review;

(iii) an English version available to allow critical analysis of the study. 2 Some interventions that describe themselves as mindfulness-based do not include any actual mindfulness practice, such as some of the ACT interventions for psychosis.

94

Dissertations, theses, books, and reviews were excluded from the search

results. Two additional papers that were not identified by the search because

they were recent and not yet included in databases were recommended by

my supervisor. The studies met the required inclusion criteria and were

added to my final set of articles.

3. Results

The search results are outlined in Figure 1. After removing duplicates

and assessing whether the studies met the inclusion criteria, 16 studies were

identified for review. The resulting studies all evaluated therapies that

included mindfulness practice, were published in peer reviewed journals,

were not dissertations, theses or reviews and all had an English language

version. The selected studies varied in the form of mindfulness intervention

used and in their design. Although the mindfulness-based intervention

varied between studies and very few studies used identical interventions, the

explicit use of mindfulness practice within the intervention and the

similarity of mindfulness exercises meant that all the studies could be

reviewed together. I am going to organise the results by design to improve

clarity and structure of the description and critique of the studies.

An overview of the characteristics and outcomes of each study is

provided in Table 1. Further description of each piece of research is found

in the text, with strengths and limitations identified for each individual study

and by group where appropriate. These results are a reflection of the current

literature on mindfulness based treatments for psychosis as interpreted by

the reviewer.

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Remove Duplicates -181

Remove articles not meeting criteria -171

Add articles suggested by supervisor +2

Figure 1. Diagram of systematic search process

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Results from searches on 18/12/2012:

PsycInfo – 143 results

Scopus – 105 results

Web of Knowledge – 118 results

185 results

14 results

16 results

Table 1.

Study Design Sample Intervention OutcomeQualitative Studies

Abba, Chadwick & Stevenson, (2008). Responding mindfully to distressing psychosis – A grounded theory.

Grounded Theory Analysis

16 with distressing psychosis (4 female, 12 male; 22 – 58 years)

Group Mindfulness Intervention (Chadwick et al., 2005; min. 4 sessions)

Theorised a 3 stage process of relating differently to distressing psychosis through mindfulness

Goodliffe et al., (2010). Group person-based cognitive therapy for distressing voices – Views from the hearers.

Grounded Theory Analysis

18 with distressing voices (12 female, 6 male; 30 – 59 years)

Group Person Based Cognitive Therapy Intervention (PBCT, Chadwick, 2006; 8 sessions)

4 main categories emerged relating to the mechanisms and benefits of PBCT for people with distressing voices

Brown et al., (2010). Participant Perspectives on Mindfulness meditation training for anxiety in schizophrenia.

Content Analysis 15 with diagnosis of schizophrenia or schizoaffective disorder (15 males; 48 – 55 years)

Group Mindfulness Intervention (16 sessions over 8 weeks)

4 frequently mentioned themes emerged relating to participants perceived benefits from mindfulness for psychosis groups

Ashcroft et al., (2012). Mindfulness groups for early psychosis – A qualitative study.

Grounded Theory Analysis

9 with positive symptoms of psychosis from an early intervention for psychosis service (2 female, 7 male; mean age 25)

Group Mindfulness Intervention (min. 6 sessions and 20 weeks)

4 main categories emerged regarding benefits of mindfulness practice

May et al., (2012). Participant experiences of group PBCT for distressing voices.

Thematic Analysis 10 with diagnosis of schizophrenia, psychosis, PD or PTSD (5 female, 5 male; 36 – 55 years)

Group PBCT intervention (6 or more sessions over 12 weeks)

3 themes unique to PBCT emerged supporting the value of PBCT groups for distressing voices.

Table 1. cont.

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Study Design Sample Intervention OutcomeCase Studies

Davis et al., (2007). Mindfulness – An intervention for anxiety in schizophrenia.

Evaluation Interviews (mid and end point)

1 person with diagnosis of schizophrenia or schizoaffective disorder (male)

Group Mindfulness adapted from MBSR and MBCT (16 sessions over 8 weeks)

Benefits described as being better able to observe own thinking and more aware of emotions

Newman Taylor et al., (2009). Impact of mindfulness on cognition and affect in voice hearing: Evidence from two case studies.

Quantitative methods used

2 people with distressing voices (males; 51 and 63 years old)

Individual Mindfulness Intervention (Chadwick 2006; 12 sessions)

For both cases distress and cognition conviction ratings fell. Mindfulness scores increased, change only clinically significant3 for participant B. No data included regarding reliable change for any of the measures

Ellett, (2012). Mindfulness for paranoia: Evidence from two case studies.

Quantitative methods used

2 cases, Delusional Disorder diagnosis (males; 34 and 49 years old)

Individual Mindfulness Intervention (Chadwick et al., 2005; 6 sessions)

Reductions in key dimensions of paranoid beliefs, depression, and anxiety. Mindfulness scores increased. No data included regarding reliable change for any of the measures.

Table 1. cont.

Study Design Sample Dropout Rate Intervention Outcome

3 Measure of clinical significance as described by Jacobson and Truax (1991)

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Quantitative Studies(uncontrolled)Chadwick et al., (2005). Mindfulness groups for people with psychosis.

Non randomised, uncontrolled trial

11 with distressing psychotic experiences (4 female, 7 male; mean age 33)

4 (1 before therapy started, 3 after one session)

Group Mindfulness Intervention (protocol developed in pilot; 6 sessions)

Significant pre-post drop in scores on the CORE (p=.008, Cohen’s d4=0.53). Secondary data showed a non-significant change in mindfulness.

Dannahy et al., (2011). Group PBCT for distressing voices.

Non randomised, uncontrolled trial

62 with distressing voices for at least 2 years (40 female, 22 male; mean age 41)

12 (9 before post-group measures, 3 before follow-up measures)

Group PBCT intervention (9 – 12 sessions)

Significant pre-post improvements on general wellbeing measures (p<.001, d=.57), ratings of voice distress (p<.001, d=.75) and voice control (p<.001, d=.62).

Van der Valk et al., (2012). Feasibility of mindfulness based therapy in patients recovering from a first psychotic episode: a pilot study.

Non randomised, uncontrolledprospective follow-up trial

16 with recent onset of psychosis (4 female, 12 male; mean age 31.8)

4 (1 before therapy started, 3 unable to complete therapy)

Group mindfulness based therapy (8 sessions)

No significant increase in mindfulness. Significant decrease in agoraphobic symptoms (p<.028, d=.96) and in psychoneuroticism (p<.025, d=.98).

Lalova et al., (2012). Mechanisms of insight in schizophrenia and impact of cognitive remediation therapy.

pseudo-randomized, uncontrolled trial

63 with schizophrenia diagnosis (19 female, 44 male; 18 – 25 years)

3 (0 from MBCT arm) MBCT (12 sessions), compared with 2 other cognitive remediation therapies

Insight improved significantly in all treatment groups. MBCT showed more improvement on symptomatic attribution than other groups (p<.001, d=1.7).

Table 1. cont.

Study Design Sample Dropout Rate Intervention OutcomeQuantitative Studies

4 Cohen’s d = (mean pre intervention – mean post intervention) / pooled standard deviation

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(controlled)

Chadwick et al., (2009). Mindfulness Groups for voices and paranoia: A Replication and Randomized Feasibility Trial.

Randomised controlled feasibility trial

22 with distressing voices (mean age 41)

2 out of 11 from treatment arm

Group Mindfulness Intervention (Chadwick 2006; 10 sessions)

Between-Groups: No significant differences between groups (CORE: p=.233, d5=0.56; SMQ: p=.085 d=0.86).

Within-Groups: Secondary analyses show significant pre-post improvement in clinical functioning (p=.013) and mindfulness scores (p=.037) following the intervention.

White et al., (2011). A feasibility study of Acceptance and Commitment Therapy for emotional dysfunction following psychosis.

Single-blind pilot randomised controlled trial

27 with diagnosis of a psychotic disorder (6 female, 21 male; mean age 34)

0 out of 14 from treatment arm

Individual acceptance and commitment therapy including mindfulness exercise (ACT, max. 10 sessions)

Between-Groups: Significant difference in mindfulness skills (p=.015, d = 1.16) and in negative symptoms (p=.029, d = 1.08) between ACT group and control group. Other between-group differences were not significant.

Post-Hoc: Significantly greater proportion of ACT group changed to not being depressed at follow up in comparison to participants in the control group (p<.05)

Table 1. cont.

Study Design Sample Dropout Rate Intervention OutcomeQuantitative Studies(controlled)

Shawyer et al., (2012). A Single-blind 43 with 1 out of 21 from TORCH including Between-Groups: No significant differences in primary

5 Cohen’s d = (mean change Group 1 – mean change Group 2) / pooled standard deviation

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randomised controlled trial of acceptance-based cognitive behavioural therapy for command hallucinations in psychotic disorders.

randomised controlled trial

command hallucinations (18 – 65 years)

treatment arm mindfulness exercises (15 sessions); comparison treatment: befriending; control: wait list.

outcomes (resisting command hallucinations: d6= 0.07; coping with command hallucinations: d=0.31) or on secondary outcome measures.

Post-Hoc: Comparisons between treatment groups and wait list show significant difference on coping (p<.01, d=1.07) and some secondary outcome measures.

Within-Groups: Both treatment groups showed some significant pre-post improvements on different sets of outcome measures.

Langer (2012). Applying Mindfulness Therapy in a Group of Psychotic Individuals: A Controlled Study.

Randomised controlled trial

18 with psychosis related diagnosis (mean age 34)

4 out of 11 from treatment arm

Group Mindfulness Intervention (Segal et al. 2002; 8 sessions)

Between Groups: Significant difference in Mindfulness response (SMQ: p<.05, d=1.12). Differences on all other measures in expected direction but not significant (GSI: d=0.57; AAQII: d=0.15)

6 Cohen’s d = (mean change Group 1 – mean change Group 2) / pooled standard deviation

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3.1 Qualitative Studies

There were three qualitative studies involving mindfulness for distress related to

psychosis that used grounded theory. Abba et al. (2008) used a group mindfulness

intervention with a standardised protocol. They approached the first sixteen people to

complete a local mindfulness group who had attended at least four of the sessions. All

participants were assessed as experiencing distressing psychosis with some hearing voices

and others experiencing other hallucinations. The interviews were carried out with between

one and four participants present. The study developed a substantive theory that mindfulness

practice affects a three stage process of relating to difficult psychotic experience in a different

way. The processes theorised involved gaining awareness of psychosis, allowing internal

stimuli to come and go without reacting, and reclaiming power through acceptance.

The study by Goodliffe et al. (2010) used grounded theory to research a group PBCT

intervention over eight sessions. Participants had a diagnosis of schizophrenia or

schizoaffective disorder and had experienced distressing voices. People attending the group

were invited during the final session to attend a focus group where the data was gathered. The

grounded theory analysis generated four main categories relating to the benefits of group

therapy in general and the specific intervention. Although aspects of these main categories

such as acceptance could be seen to relate to mindfulness, mindfulness processes were not

spoken about by participants. This is possibly due to the limited amount of mindfulness

involved in the intervention. For this reason it is difficult to gain understanding from this

study regarding the impact of mindfulness on this population.

A third study to use grounded theory was Ashcroft et al. (2012). They used a group

mindfulness intervention offered within an Early Intervention for Psychosis (EIP) service.

Participants were all supported by the EIP service and had to attend at least six sessions to be

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included in the study. Interviews were conducted at least twenty weeks after their first

mindfulness session to allow for the impact of home practice. The interview data was

analysed by an independent researcher without past experience of mindfulness because prior

knowledge of mindfulness could potentially bias the interpretation of the data. Four main

categories emerged from the data regarding the benefits of mindfulness practice for clients of

the EIP service and showed parallels with the results from the Abba et al. (2008) study whilst

highlighting specific differences in the experience of EIP clients.

May et al. (2012) conducted a thematic analysis on interview data from ten

participants who attended group PBCT. The PBCT protocol was revised following the

findings from Goodliffe et al. (2010) to incorporate much more mindfulness practice and

principles. Participants that attended six or more sessions of PBCT over a twelve week period

were invited to discuss their experience of therapy. The data was analysed by an independent

researcher who was relatively naïve to PBCT and mindfulness-based approaches to allow

them to have an independent view on the data. Three themes unique to PBCT were generated

that involved relating differently to voices, self and others. Participants also reported that

mindfulness was an important part of therapy.

Content Analysis was utilised by Brown et al. (2010) to research the impact of a

group mindfulness intervention with sixteen sessions over eight weeks. All participants had a

diagnosis of schizophrenia or schizoaffective disorder, were not in an acute phase, and

experienced anxiety. Interviews were conducted by program instructors and the resulting data

was analysed independently. Four frequently mentioned themes emerged relating to

perceived benefits of mindfulness.

All these qualitative studies used a sample consisting of participants who did not drop

out of therapy and who consented to attend interviews. This created self-selected samples that

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excluded participants who dropped out, did not attend regularly, or chose not to attend

interviews. This limits the conclusions that can be made because it is possible the samples

only represent a very specific group of therapy participants. For example, people that may

have found the experience negative may have been more likely to attend irregularly, drop out

from the therapy or not volunteer to take part in an interview. Without their data, the results

are likely to give an overly positive picture. Moreover, participants who choose to feedback

may be more likely to want to please the researcher and say what they think is expected of

them in line with the social desirability response (Crowne & Marlow, 1964). Therefore this

selection process could potentially cause excessively positive conclusions about the

interventions.

Interview data might also have been influenced by conducting interviews with

variable numbers of participants. Abba et al. (2008) conducted interviews with between one

and four participants in each group. An interview with one participant could potentially

produce very different responses compared to a group interview. Moreover, groups of

different sizes will create different dynamics with more or less opportunity for participants to

either encourage or inhibit each other. This could have potentially impacted the data collected

and limited conclusions from the study.

In the Ashcroft et al. (2012) and Brown et al. (2012) studies, interview data may have

been further limited by interviews being conducted by the group therapists. This may have

improved engagement in the interviews however it may well have caused biased responses

due to the relationship and rapport between the therapist and participant changing the way the

participant responds. For example, it might have been very difficult for participants to have

been critical of the therapy when being interviewed by the person who conducted the therapy.

Therefore this may have produced overly positive responses, creating unrepresentative data

for analysis.

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A strength of Abba et al. (2008) was that the researcher conducting interviews and

analysing data did not facilitate the mindfulness groups. However they did work clinically

alongside the group facilitators and therefore the analysis of the researcher could have been

influenced by the facilitators. Furthermore, the primary group facilitator was involved in the

qualitative study which could have influenced the data analysis. May et al. (2012) controlled

well for researcher influence by using an analyst that was intentionally not part of the

research team, thus helping to maintain an independent view. Despite this some influence

may have occurred because the analyst was supervised by a member of the research team and

therefore it may have been difficult to have analysed the data in a way that might have

reflected badly on the research team.

Conclusions about the impact of mindfulness are limited by the lack of clarity about

the relative influence of mindfulness on the data that was produced. The lack of any measure

of home practice allows for large potential variability in the level of mindfulness experience

of participants and could impact on interview responses. The PBCT used in Goodliffe et al.

(2010) and May et al. (2012) varied between studies on the amount of mindfulness practice

included and therefore mindfulness will have had a differing influence on the results of each

study. Also PBCT incorporates mindfulness with cognitive therapy for psychosis and caution

needs to be taken regarding the relative influence of mindfulness compared to other elements

of the intervention.

The qualitative studies reviewed here use different approaches, with three using

grounded theory, one using thematic analysis and one content analysis. The grounded theory

used specifically sets out to identify concepts in the data for the purpose of generating theory.

This is based on positivist epistemology (Strauss & Corbin, 1998) with the purpose to

develop a theory in an under theorised area. However it is questionable whether grounded

theory has been applied appropriately in these studies. There appears to be no indication of

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theoretical sampling or of attempting to achieve saturation by continuing to analyse and

gather more data based on the developing model until the model is complete. Due to this it

would appear that the approach these three studies use is more like thematic analysis and

therefore the models they produce should be in line with this.

The qualitative studies described here were able to propose themes relating to how

and why the mindfulness process impacts psychotic experience, such as awareness,

acceptance, and relating differently to self and others. This is a unique strength of these

studies due to the richness of data that can be collected from interviews with participants.

This can give a depth of insight into why change occurs and a better understanding of the

processes involved. These studies were limited however by their participant selection

processes which involved excluding drop outs from therapy and only included those who

volunteered to be interviewed, thus potentially accessing a sample with excessively positive

views of the intervention. A further reason to be cautious about conclusions from these

studies is the involvement of researchers and supervisors in interviews and analysis who were

interested in supporting the benefits of their therapeutic intervention.

3.2 Case Studies

The literature search carried out found three case studies evaluating mindfulness-

based interventions for distress related to psychosis. The intention of the Davis et al. (2007)

study was to develop a mindfulness-based intervention for individuals experiencing

schizophrenia-related anxiety. Therefore the article focuses predominantly on the

development process and testing the acceptability of the intervention rather than measuring

change. The intervention was adapted from MBSR and MBCT and involved sixteen

mindfulness sessions over eight weeks. The case study briefly describes one participant’s

experience of the intervention. Feedback was gained through interviews conducted by the

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author at mid- and end-point and benefits of the intervention were that the participant was

better able to observe their own thinking and had more awareness of emotions. The interview

data was not methodically analysed using recognised qualitative techniques and quantitative

outcome measures were not used. Therefore this study can only be taken in isolation as

describing the possible benefit experienced by one individual who participated in this

intervention

A study by Newman Taylor et al. (2009) aimed to test whether mindfulness training

alone would reduce distress and belief conviction in people who experience auditory

hallucinations. Two cases are presented of people who experienced distressing voices and

who completed a 12 session individual mindfulness intervention following a researched

protocol (Chadwick, 2006). Both people were men over fifty years of age who had no prior

experience of mindfulness. The absence of prior mindfulness experience controls for the

impact previous mindfulness training may have, thus improving conclusions made about the

impact of the intervention. Visual analogue measures of distress and belief conviction were

taken after and between each session to give insight into in session effects and generalisation.

The Southampton Mindfulness of Voices Questionnaire (SMVQ) was used to assess levels of

mindfulness at baseline and end point. For both people in this study distress and belief

conviction ratings reduced and mindfulness scores increased. Using a measure of clinical

significance described by Jacobson and Truax (1991), the increase in mindfulness was

clinically significant for one participant however there was no data on whether change on any

measures for either participant could be considered as reliable change.

Two cases are presented in a study by Ellett (2012) that focused on the impact of

mindfulness on persecutory delusions for people not experiencing distressing voices. This

contrasts to the majority of research on mindfulness-based interventions for distress related to

psychosis that has tended to either focus on distressing voices or incorporate a range of

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presentations that include auditory hallucinations. In this study an individual six session

mindfulness intervention was used following the protocol from Chadwick et al. (2005). The

participants were both men with current distressing paranoid beliefs who were naive to

meditation. Ratings were taken of persecutory belief dimensions using visual analogue rating

scales at end of session and between sessions. The Southampton Mindfulness Questionnaire

(SMQ) and the Hospital Anxiety and Depression Scale (HADS) were used at baseline, end of

treatment and one month follow up to assess levels of mindfulness, anxiety and depression.

The results show reductions in key dimensions of paranoid beliefs, depression and anxiety,

and increases in mindfulness scores. Positive behaviour change was reported by participants

and validated by professionals working with them. The participant scores on the HADS

indicate that one participant changed from clinical levels of anxiety and depression to non-

clinical levels, while the other participant changed from clinical levels to borderline clinical

levels of anxiety and depression (Snaith, 2003). These changes were sustained over the one

month follow up period, however there is no data reported regarding reliable change.

The Interview feedback in Davis et al. (2007) was gathered by the group facilitator

and therefore the responses of the participants may be influenced by the relationship formed

in therapy, potentially leading to overly positive feedback to please the therapist.

Furthermore, the person collecting the interview data and conducting the therapy was the

primary author and therefore was invested in supporting the therapeutic intervention they

were developing. This could not only impact the responses of participants but also the way

the data was analysed, with the researcher potentially focussing more on the positive

responses and discounting negative responses, thus limiting the conclusions drawn from the

research.

Newman Taylor et al. (2009) and Ellett (2012) employed quantitative measures with

their case studies. In case study designs that employ quantitative measures it is essential to

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establish a stable baseline because the baseline period acts as a control with which to

compare the intervention period against (Kazdin, 1982). It is usual practice for participants to

complete the measures for at least four sessions prior to the intervention starting to establish

that change is not occurring outside of the intervention. However both of these studies failed

to have at least four sessions as a baseline prior to therapy, thus limiting conclusions about

the relative influence of the intervention.

The visual analogue ratings used in Newman Taylor et al. (2009) and Ellett (2012)

give no insight into whether change was reliable and/or clinically significant. Furthermore,

there is no data included regarding reliable change for any of the measures used in these

studies. Without this information it cannot be determined whether change on the measures

occurred purely by chance rather than due to the intervention. These studies were further

limited by having no formal measure of home practice, potentially leading to unaccounted for

variability and giving no insight into the importance or relevance of this aspect of the

intervention.

The case studies reviewed evaluate mindfulness-based interventions and investigate

aspects of participant experience such as anxiety, depression and paranoid beliefs. A detailed

focus on one or two people’s experience potentially gives more breadth and depth about

participant experience. These studies have associated mindfulness with reductions in ratings

of distress and belief conviction, reductions in anxiety and depression, and a qualitative

increase in self-awareness. However the conclusions are limited by an absence of data on

reliable change and inadequate periods of baseline measurement to act as a control to

compare the intervention to. Therefore it is not possible to fully establish whether changes

made are mediated by mindfulness or other extraneous factors. The qualitative results are

further limited by not having an independent, impartial researcher involved to interview and

analyse data.

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3.3 Quantitative Studies

The searches conducted produced eight studies that use a quantitative design with

multiple participants. Of those studies, four used a control group to compare with the

mindfulness-based intervention.

3.3.1 Uncontrolled trials

Chadwick et al. (2005) conducted a trial of a group mindfulness intervention using a

protocol they developed with a pilot group. The participants had all experienced distressing

psychotic symptoms for at least two years. Fifteen people were referred to the mindfulness

groups, one dropped out before therapy and three dropped out after one session leaving

eleven participants in the study. The primary outcome measure used in this study was the

Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a generic

measure of psychological distress comprising of four domains: wellbeing, symptoms,

functioning, and risk. The SMQ was used to assess levels of mindfulness pre- and post-

intervention and therapeutic factors were ranked by participants in post intervention

assessments. The results demonstrated a drop in scores from pre- to post-intervention with

analysis revealing a significant reduction over the duration of the group, with a medium

effect size. Improvement in overall mindfulness skills were indicated by the secondary data

analysis however whether these differences were significant was not reported. Mindfulness

was ranked first by participants when ranking the subjective importance of a list of

therapeutic factors.

A study by Dannahy et al. (2011) investigated the effect of group PBCT on sixty two

participants who had experienced distressing voices for at least two years. The PBCT groups

originally lasted for eight sessions, however following feedback the final three of the nine

groups ran for twelve sessions. Participants attended between six and twelve sessions and

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twelve participants dropped out in total with a last observation carried forward method used

to complete the missing data. Outcome measures used were the CORE-OM, visual analogue

ratings of voice distress and voice control, and the Voice and You (VAY) measure. Results

showed significant pre-post improvements with medium effect size on the CORE-OM and on

ratings of voice distress and voice control. The VAY is a measure of the relationship between

the hearer and the voice, however results from the VAY were varied and there were no

significant pre-post changes on any of the VAY subscales.

A pilot study conducted by Van der Valk et al. (2012) evaluated the feasibility of

mindfulness-based therapy for people recovering from a first psychotic episode. Sixteen

participants were recruited from the EIP service with a range of diagnoses that involved

psychotic experiences. Three participants dropped out from the study with thirteen

completing therapy. The Positive and Negative Syndrome Scale (PANSS), Symptoms

Checklist 90 and the SMQ outcome scales were used before and after the intervention.

Results from the study indicated no adverse effects on psychotic symptoms but also no

significant increase in mindfulness. The SMQ was found to have unsatisfactory inter item

correlations with this sample, which raised questions about the reliability of the measure.

Results also indicated a pre-post decrease in agoraphobic symptoms and psychoneuroticism

with significant and large effect sizes, indicating symptoms that could be potentially

benefited by mindfulness based therapies.

Lallova et al. (2012) conducted a study to compare the impact of three types of

cognitive remediation therapy on aspects of insight in people diagnosed with schizophrenia.

The therapeutic interventions compared were Cognitive Remediation for Schizophrenia,

Autobiographical Reminiscence therapy, and a twelve session course of MBCT. Group

allocation was not randomised with 22 participants assigned to each intervention. Three

people dropped out from the study however none of those were from the MBCT group.

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Results showed that insight improved in all treatment groups. MBCT specifically showed

more improvement on symptomatic attribution than the other groups with a significant and

large effect size. The focus of this study on insight is significant for mindfulness for

psychosis research because it has been suggested that meta-cognitive insight is an important

process in mindfulness-based therapy (Teesdale et al. 2002).

With the exception of Dannahy et al. (2011), these studies all lack data from

participants who dropped out of therapy. This potentially creates a positive bias in the results

as participants may drop out if they deteriorate or have an adverse reaction to the

intervention. Dannahy et al. (2011) included drop out data by using a last observation carried

forward method. This has the advantage of not dismissing data from participants who drop

out however it assumes stability which can also potentially influence the results. The drop out

data could possibly be better controlled for using mixed methods (Hamer and Simpson,

2009).

The conclusions made by these studies are also limited by the measures they use.

Lallova et al. (2012) use no measure of clinical change and therefore conclusions regarding

the impact of mindfulness on clinical functioning are limited. Dannahy et al. (2011) and

Lallova et al. (2012) do not include a measure of mindfulness and therefore it is impossible to

assess the relative impact of the mindfulness element compared to other aspects of PBCT or

MBCT. The absence of follow up measures in Chadwick et al. (2005) and Lallova et al.

(2012) studies mean that no conclusions can be made about the sustainability of any change.

Some these uncontrolled studies did find statistically significant change in

mindfulness and on some clinically-relevant measures such as the CORE-OM. These studies

have also indicted the feasibility of recruiting and retaining participants for research into

mindfulness-based interventions. However the absence of a control group limits potential

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conclusions because any changes might have occurred with no intervention. This means it

cannot be assumed that mindfulness was a necessary or sufficient cause of clinical

improvement in any of these studies. Furthermore, the absence of randomisation allows more

influence of bias and other extraneous factors influencing the results.

3.3.2 Controlled Trials

A randomised controlled feasibility trial was conducted by Chadwick et al. (2009)

evaluating mindfulness groups for people who had experienced distressing voices for at least

two years. Twenty two participants were recruited to the study and randomly assigned to

either group mindfulness therapy or waiting list. The intervention involved ten sessions over

five weeks, with concurrent home practice, and then five weeks of independent home

practice. Secondary analyses were conducted on data from waiting list participants who

undertook the same therapy regime following the initial analysis. Outcome measures used

included the CORE-OM, SMQ, SMVQ, the Psychiatric Symptom Rating Scale (PSYRATS)

to evaluate the severity and intensity of auditory hallucinations and delusional symptoms, and

the Beliefs about Voices Questionnaire revised (BAVQr) to measure beliefs about and

relationships to distressing voices. Participants were also asked to rank a list of therapeutic

factors.

Two participants dropped out of the treatment arm leaving nine to complete the

intervention. The primary analyses show no significant differences between control and

treatment groups at post-intervention. The mean CORE score decreased more in the treatment

group than in the wait-list group with a non-significant medium effect size, and the SMQ

scores increased more for the treatment group with a non-significant large effect size.

Secondary pre-post analyses included the waiting list participants once they had completed

the therapy program and found significant improvement in clinical functioning and

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mindfulness scores. Despite the absence of significant between-group results, this study

indicated that it is possible to conduct randomised controlled trials (RCTs) in this area and

also provided an effect size for powering a full trial of the therapy.

In a similar study, Langer (2012) evaluated group MBCT for people with a psychosis

related diagnosis using a RCT design. The intervention lasted eight sessions following a

standardised protocol and twenty three participants were randomly assigned to either MBCT

or waiting list. Two participants dropped out from therapy and two attended irregularly

leaving a final sample of seven in the treatment group. To assess symptoms related to

schizophrenia the Clinical Global Impression-Schizophrenia Scale was used, the Acceptance

and Action Questionnaire (AAQ) was used to assess experiential avoidance, and the SMQ

was used to assess mindfulness levels. The results show significant between group

differences on the SMQ with a large effect size, however no other significant differences

were found between groups. Pre-post change on all measures was in the expected direction

for MBCT participants.

White et al. (2011) conducted an RCT evaluating ACT for emotional dysfunction

following psychosis. The ACT protocol used involved up to ten individual sessions and had a

strong mindfulness component including a mindfulness of breathing exercise from Chadwick

et al. (2005). Twenty seven participants with a diagnosis of a psychotic disorder were

randomly assigned to either treatment as usual (TAU) or ACT plus TAU. It is notable that no

participants dropped out of the intervention arm, possibly indicating the acceptability of ACT

or reflecting the tolerability of individual therapy compared to group therapy for this

population. Outcome measures included the HADS, PANSS, AAQ, and Kentucky Inventory

of Mindfulness Skills (KIMS). Measures were taken at baseline and three months post

baseline and together these measures gave a reflection of general clinical outcomes and

therapy specific change. The results from this study show significant between group

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differences in mindfulness skills and negative symptoms with large effect sizes. All other

between group differences were not significant. Post-hoc analysis indicated that a

significantly greater proportion of the treatment group changed to not being depressed at

follow up.

A randomised controlled trial by Shawyer et al. (2102) compared TORCH (Treatment

of Resistant Command Hallucinations) with befriending and waiting list controls for people

experiencing command hallucinations in psychotic disorders. The TORCH intervention

involved in session mindfulness exercises and encouraged home practice. Forty three

participants were randomly assigned to either fifteen sessions of individual TORCH therapy

or the befriending comparison intervention. Within that allocation, seventeen participants

were randomly assigned to a waiting list before commencing TORCH or befriending. Both

treatments were conducted by therapists following standardised protocols. A random sample

of sessions were recorded and audited to ensure quality control and therapist adherence to

guidelines.

A battery of outcome measures were taken at baseline, end point and six month

follow up. Primary outcomes evaluated compliance with command hallucinations; secondary

outcomes measured illness severity, functioning, distress and quality of life; and process

measures assessed involvement with voices and acceptance of voices. Results from this trial

display no significant differences and small effect sizes between TORCH and befriending on

primary outcome measures. This is also the case with secondary outcome measures and

comparisons with waiting list suggest that both TORCH and befriending were beneficial

compared to waiting list. Within group pre-post measures suggested that both TORCH and

befriending had significant positive outcomes with differential patterns. This would suggest

that TORCH is no more beneficial than befriending for treating this client group.

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The relatively small sample sizes used in all of these controlled trials mean that they

are all under powered. This limits their ability to find significant differences and increases the

chances of making a type II error. An example of this is in the Chadwick et al. (2009) study

where the between group change on the CORE-OM displayed a medium effect size but was

not significant. This highlights the need for a fully powered trial in this area. Where between

group differences were not found, within group differences were reported and these analyses

have the same limitations as the uncontrolled trials highlighted earlier. Furthermore, all the

trials except for Shawyer et al. (2012) only included inactive control groups. Without active

control groups non-specific therapy factors are not controlled for and cannot be discounted as

the cause of any change. This is underlined by Shawyer et al. (2012) who found the active

control group to be as effective as the mindfulness-based intervention, suggesting that non-

specific therapy factors could be the important mediator to change.

These four studies have generally failed to gain significant between-group results,

especially on primary outcome measures. This is potentially due to relatively small sample

sizes creating a lack of statistical power, however it is also possible that the failure to gain

significant between-group results is because mindfulness-based interventions are not

effective for psychotic distress.

4. Discussion

The purpose of this review was to describe and evaluate the present evidence regarding

the effectiveness of mindfulness-based treatments for psychosis and highlight where future

research needs to focus. The overall picture given by this appraisal of the current literature is

that at present there is a lack of evidence from high quality studies for the effectiveness of

mindfulness-based interventions for distress related to psychosis. Generally speaking

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however these studies have shown that mindfulness-based interventions are acceptable to this

client group as drop out rates were from the therapy were low.

4.1 Summary of Results

The qualitative studies reviewed have highlighted the active processes of increasing

both self-understanding and the awareness of psychosis through mindfulness; changes that

potentially facilitate the process of relating differently to voices, self and others. The

qualitative studies also emphasised the central role acceptance might have for people

benefiting from mindfulness-based interventions. Case studies have proposed that

participants have benefited with regard to ratings of distress, belief conviction, anxiety and

depression. Results from some of the uncontrolled trials have shown statistically significant

change in mindfulness and on measures of general psychological distress. However all of the

studies finding these benefits have methodological issues and have not managed to discount

extraneous factors from mediating change. The controlled trials generally failed to gain

significant between-group results, especially on primary outcome measures, suggesting that

there is potentially little or no impact of mindfulness-based interventions for psychosis.

However, all the controlled trials were underpowered to find anything other than a large

effect size and so at the moment the trials do not allow us to draw conclusions about the

effectiveness of mindfulness-based interventions for psychosis.

4.2 Links to the Literature

This review has focussed on interventions that explicitly use mindfulness practice for

psychosis related distress however the findings are comparable to reviews that have covered a

broader range of treatments and presentations. In a review of third wave treatments, Ost

(2008) concluded that a lack of methodological rigour in trials meant there was insufficient

evidence for any of the therapies in the review to be considered as empirically supported.

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Similarly, in a review of a broad range of mindfulness-related interventions for serious

mental illness, Davis and Kurzban (2012) found that their conclusions were restricted by a

scarcity of rigorously controlled trials.

Mindfulness theory asserts that distress is mediated by how one relates to experience,

rather than by the experience itself (Abba et al., 2008). Accordingly, mindfulness helps

reduce distress by giving people the skills to relate and respond differently to their

experiences through observation and acceptance. For distress related to psychosis, it is

proposed that awareness and acceptance of experiences without judging can replace

experiential avoidance, rumination and confrontation (Chadwick et al. 2005). However,

considering the current evidence, it cannot be assumed that any benefits indicated by

interventions associated with mindfulness are mediated by helping participants to relate to

their distress differently.

4.3 Limitations in the Literature

The qualitative studies reviewed were generally limited by the self-selected samples

they used. Participants were people who did not drop out of therapy, attended regularly and

chose to give feedback at the end. This potentially created excessively positive interview data

because people who felt negatively about the therapy were possibly more likely to attend

irregularly, drop out or refuse to feedback. The qualitative studies, including the qualitative

case study, were further limited by not using independent interviewers or qualitative research

teams that were independent from the data. This allows for researchers or supervisors who

were potentially invested in supporting the benefits of the therapy to influence those

conducting interviews or analysing the data. It would be good practice for a qualitative study

to be conducted entirely independently of the research team, including supervision of the

researcher.

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The case studies described were limited by a lack of data on reliable change and

inadequate periods of baseline measurement to act as a control to compare the intervention to.

Without data on reliable change and sufficient baseline periods it is not possible to evaluate

whether changes are due to mindfulness or other factors. Conclusions from the non-

controlled trials reviewed here were limited by the absence of a control group because any

changes may have occurred with no intervention. Also the lack of randomisation allows more

influence of bias and other extraneous factors influencing the results. The controlled trials

reviewed should have had designs that account for the limitations so far described. However

all of the controlled trials reviewed were under powered due to the use of relatively small

samples, thus increasing their chances of making a type II error. Moreover, only one study

used an active control group to control for non-specific therapeutic factors.

The studies reviewed highlight that the literature is further limited by inconsistencies

evident between participants within groups. This could be due to natural variation however it

could also be due to differences in presentation relating to different outcomes. Psychosis

related diagnoses cover a wide range of symptoms and presentations and studies thus far have

tended to focus on psychosis in general, hearing voices, or psychosis-related anxiety. The

assumption here is that these presentations share a common experience, namely distressing

psychosis. However it is possible that people who have different presentations and who

experience different types of hallucinations will respond differently to mindfulness. This

potential variation is not explored and at present there is little understanding of the

effectiveness of mindfulness for different aspects of psychosis

4.4 Directions for Further Research

Future directions for research into mindfulness-based interventions for psychosis can

be guided by some of the methodological issues in the current literature. Qualitative research

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in this area would benefit from being conducted entirely independently from the research

team, so that the data and the analysis of the data are not influenced by supervisors or

researchers who are invested in the therapy. There are a number of factors that have

potentially created variability and inconsistencies in the current literature. Variability in the

use of individual and group interventions creates ambiguity for clinical guidance and

therefore research evaluating differences between group and individual mindfulness therapy

could improve clinical understanding. Inconsistencies also arise from variability of home

practice, therefore research concentrating on the impact of home practice could improve

understanding and help guide clinical practice regarding the relative importance of home

practice.

Future scientific inquiries would also benefit from the use of a consistent standardised

mindfulness protocol. At present there is a large variation in the amount and nature of

mindfulness practice involved in mindfulness-based interventions creating ambiguity

regarding the relative impact of mindfulness. There is also little understanding regarding how

effective mindfulness is for specific psychosis related presentations. Research could

investigate whether mindfulness is more effective for certain presentations or aspects of the

psychotic experience. Such studies could focus on specific symptoms such as delusions,

specific types of hallucination, or paranoia. This review has also highlighted the need for

robust, adequately powered studies with active and inactive control groups to help gain

definitive conclusions regarding the relative impact and effectiveness of mindfulness-based

interventions for distress related to psychosis.

4.5 Conclusion

The methodological issues and limitations present in the current literature make it

difficult to draw conclusions about the effectiveness of mindfulness-based interventions for

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psychosis. There appears to be support for the safety and acceptability of mindfulness for

people with psychosis related distress. However there is currently no evidence at present to

support the impact or efficacy of mindfulness for psychosis in comparison to other

therapeutic interventions or non-specific therapeutic factors.

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Summary of Clinical Experience

Specialist Placement - Neuropsychology: April 2015 - September 2015

Working in a split placement between an acute brain injury inpatient ward, a neurology outpatient service and an inpatient neuro-rehabilitation service.

Using appropriate assessment tools and techniques to assess adults with neurological difficulties and psychological difficulties associated with neurological conditions and trauma, including TBI, stroke and neurodegenerative disorders.

Planning intervention strategies and working therapeutically with clients presenting with neurological difficulties.

Developed Competence with many standardised cognitive assessments including, but not limited to:

WAIS-IV, WMS-IV, BMIPB, D-KEFS, BADS, TEA, VOSP, TOPF, WISC-IV, Hayling and Brixton

Child and Adolescent Mental Health Service: Oct. 2014 - March 2015

Working therapeutically using CBT and Narrative Therapy models with a range of psychological presentations.

Supervising the work of an Assistant Psychologist including supervising graded exposure work and the running of an anxiety management group.

Assisting with neurodevelopmental disorder assessments.

Neuropsychological assessment using the WISC-IV, WIAT-II and NEPSY.

Conducting school observations and working indirectly with families and schools.

Community Team for People with Learning Disabilities: April 2014 – Sept. 2015

Working therapeutically with adults with a range of learning disabilities.

Use of Cognitive Analytic Therapy under supervision to work on relational issues in therapy.

Use of functional analysis and behavioural interventions.

Providing teaching to day services on dementia in adults with learning disabilities.

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Community Mental Health Team for Older People: Oct. 2013 - March 2014

Completing regular comprehensive neurodegenerative disorder assessments with the use of a wide range of well validated neuropsychological assessment tools including the WAIS-IV, WMS-IV, D-KEFS, BADS and the VOSP.

Use of CBT with older adults presenting with anxiety and depression.

Use of CBT and behavioural interventions to provide post-stroke support.

Teaching to the MDT on neuropsychological assessment.

Community Mental Health Recovery Service: Oct 2012 - September 2013

Working therapeutically using CBT and ACT models with adults presenting with OCD, depression, social anxiety and borderline personality disorder.

Running CBT skills and mindfulness for psychosis groups.

Presenting to the MDT on mindfulness.

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Assessments

Year I Assessments

PROGRAMME COMPONENT

TITLE OF ASSIGNMENT

Fundamentals of Theory and Practice in Clinical Psychology (FTPCP)

Wechsler Adult Intelligence Scale IV Scoring and Analysis of Subtests and Indices Exercise

Research –SRRP Service Evaluation of the Serious Incident Support Team

Practice case report Cognitive Behavioural Therapy with a man in his fifties presenting with chronic Anxiety and Depression

Problem Based Learning – Reflective Account

‘Relationship to Change’: PBL Reflective Account

Research – Literature Review

Mindfulness-based treatment for psychosis: A Literature Review of Effectiveness

Adult – case report Cognitive Behavioural Therapy with a man in his fifties presenting with chronic Anxiety, Depression and Low Self-esteem

Adult – case report Cognitive Behavioural Therapy with a man in his fifties presenting with chronic Obsessive-Compulsive Disorder

Research – Qualitative Research Project

‘Therapy on the Phone; Therapist Experiences of Delivering Telephone Interventions’

Research – Major Research Project Proposal

A randomised controlled trial of the impact of an online MBT course on paranoid thoughts in a non-clinical population

Year II Assessments

PROGRAMME COMPONENT

TITLE OF ASSESSMENT

Research Research Methods and Statistics testProfessional Issues Essay

Critically explore the statement that clinical psychology should “move away from psychiatric diagnoses…., which have significant conceptual and empirical limitations, and develop alternative approaches which recognise the centrality of the complex range of life experiences…” (Position Statement on the Classification of Behaviour and Experience in Relation to Functional Psychiatric Diagnoses: Time for a Paradigm Shift, BPS, 2013).

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Problem Based Learning – Reflective Account

PBL Reflective Account –‘The Stride Family’ Exercise

People with Learning Disabilities/Child and Family/Older People – Case Report

Neuropsychological assessment of an 84 year old male with possible cognitive decline

Personal and Professional Learning Discussion Groups – Process Account

PPLDG Process Account

People with Learning Disabilities/Child and Family/Older People – Oral Presentation of Clinical Activity

The impact of therapeutic rupture – Cognitive Analytic Therapy with a young adult male with a learning disability

Year III Assessments

PROGRAMME COMPONENT

ASSESSMENT TITLE

Research – MRP Portfolio

A Randomised Controlled Trial of an Online Mindfulness-Based Intervention for Paranoia in a Non-Clinical Population

Personal and Professional Learning – Final Reflective Account

On becoming a clinical psychologist: A retrospective, developmental, reflective account of the experience of training

Child and Family/People with Learning Disabilities/ Older People/Specialist – Case Report

A narrative approach with an adolescent female presenting with anxiety and mood difficulties

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