A qualitative exploration of the barriers to recruit people with serious mental health problems into clinical trials of

investigational medicinal products for the treatment of mental health problems

Farah Ali (FA), Pre-registration Pharmacist, The Midcounties Co-operative.

Lydia Aston (LA), PhD Student, Health Psychologist in Training, Aston University

Nichola Seare (NS), Director, Aston Health Research and Innovation Cluster, Aston University.

Ian Maidment (IM), Senior Lecturer in Clinical Pharmacy, Aston University.

Corresponding author: Ian Maidment, Pharmacy School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham, B4 7ET, i.maidment@aston.ac.uk

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Abstract

Background

Mental health problems are common affecting over 450 million people worldwide, and organisations such as the World Health Organization (WHO) and the National Institute for Health Research (NIHR) have identified the need to develop more effective treatments. Clinical trials involving investigational medicinal products (CTIMPs) are needed to develop medications. Generally recruitment to studies within mental health is challenging and there has been very little research on the barriers to people with mental health problems participating in CTIMPs.

Method

This study qualitatively explored the barriers to recruiting people with self-reported serious mental health problems into CTIMPs for mental health problems. Adults who reported mental health problems were recruited with purposive and convenience sampling for online interviews using IM (instant messaging) services. Inductive thematic analysis was conducted to identify and analyse patterns.

Results

Seventeen participants were recruited and 9 interviewed. Three main themes were identified; knowledge and understanding of clinical trials, facilitators and barriers. The study found that the people interviewed had a variable level of understanding and knowledge of clinical trials. Barriers such as lack of capacity to consent, risk of unwanted side effects, the stigma associated with mental health problems including the loss of anonymity, unknown effects of the investigational drug, and having to stop current medication with risk of relapse were identified. Facilitators such as careful monitoring, support from healthcare professionals, family and friends, and a feeling of making a difference and helping find more effective treatments were identified. Limitations of the study were that the findings may not be generalizable; none of the participants were from minority ethnic groups and all appeared well-informed and knowledgeable about clinical trials.

Conclusion

The people with self-reported mental health problems interviewed in this study appeared to possess a variable level of understanding and knowledge of clinical trials. Various barriers including the stigma associated with mental illness and facilitators exist to participation. This data should be considered preliminary and further research should focus on hard to reach populations.

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Introduction

The World Health Organization (WHO), National Institute for Health Research (NIHR) and Medical Research Council (MRC) have identified the need for new treatments for mental health illnesses (1,2). Clinical trials of investigational medicinal products (CTIMPs), the gold standard research method, explore the safety and efficacy of an investigational medicinal product in humans and are vital to develop new and effective treatments (3-8). CTIMPs are usually conducted over four phases; the drug is tested in the target population in phase III trials (9). Recruiting to CTIMPs can be challenging (10-13). Failure to recruit to time and target can increase costs and lead to early termination of the trial (7,11,12,14). It may reduce statistical power and lead to a type II error (failure to identify an effective treatment); participants will have been exposed to an experimental drug with unknown benefit (12,13,15).

Practical barriers such as transport difficulties or internal barriers, for example distrust of research may limit participation in randomised controlled trial (RCTs; 16,17). Mental health problems affect over 450 million people worldwide (18,19). A serious mental health problem typically involves psychosis or the need for a high level of care (20,21). Recruitment to clinical trials involving medication used to treat mental health problems is particularly challenging (10-12). Psychotic symptoms may distort the sufferer’s perception of reality, and symptoms such as lack of concentration and low motivation may represent barriers (22,23,24). People with schizophrenia may be less likely to participate in CTIMPs if happy with their medication, perhaps due to fear of re-lapse (25). Black and minority ethnic (BME) groups and women, who may respond to medication differently, are particularly reluctant to participate in mental health research (16,26,27).

Patient barriers need identification so that strategies to enhance recruitment to CTIMPs can be developed. However, previous mental health research has focused on barriers from the perspective of clinicians and researchers (10,24), or not specifically considered patient barriers to CTIMPs (17). With more successful CTIMPs people with mental health problems and health professionals could benefit from a wider range of potentially safer and more effective treatments in line with parity of esteem (28,29). This study aimed to interview people suffering from a serious mental health problem to identify and gain a clearer understanding of barriers to their recruitment into CTIMPs. Online interviews were conducted using internet instant messaging (IM; 30,31). Interviews can take place at anytime from anywhere and are automatically transcribed and the greater anonymity with online interviews may result in less inhibited responses (10,31,32).

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Aims and Objectives

Aim: To qualitatively explore the barriers to recruit people with serious mental health problems into CTIMPs for the treatment of mental health problems.

Objectives:

• To explore the opinions and knowledge that people with serious mental health problems have of CTIMPs

• To identify and explore the reasons for people with serious mental health problems not wanting to take part in CTIMPs

• To explore whether people with serious mental health problems are provided with adequate information and support regarding CTIMPs by their healthcare providers

Method

Study design

An exploratory qualitative approach following adopted COREQ guidelines was used with approval from Aston University Ethics Committee (33). Real-time synchronous online interviews were conducted using internet instant messaging (IM) software; Skype, Facebook or Yahoo (30,31).

Sample

The inclusion criteria were people with a self-reported diagnosis of a mental health problem aged over 18 years. Participants were asked their age at the point of recruitment and were asked again to confirm their name and age before the interview began. People below the age of 18 and those who lacked capacity to give consent as defined by the Mental Capacity Act 2005 (34) were excluded. The researchers used their professional judgement to decide on whether a participant lacked capacity. A mixture of purposive and convenience sampling was used, we purposively contacted organisations that provided services to people with mental health problems. Ultimately we relied on people to volunteer to take part in our study which contributed to the convenience sampling element of our strategy.

Procedure

A recruitment poster (Appendix 1) was emailed to a wide range of organisations which provide services, to people with mental health problems in the UK (Appendix 2) and the British Psychological Society (BPS). The organisations were requested to circulate the recruitment poster to their members. An advert also was placed in Aston Aspects (global newsletter to staff and students) to promote the study amongst students. Potential participants who expressed an interest in participation were emailed a participant information sheet (Appendix 3) and a link to the online consent form (Appendix 4). Participants were emailed a briefing before the interview (Appendix 5). Consent was re-confirmed immediately before the interview. Semi-structured interviews (see Appendix 6 for interview guide) were conducted between February 2015 and July 2015 and lasted between 45 and 60 minutes.

Data analysis

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A four-step inductive thematic approach using constant comparison was used to analyse the data (35-37). Data was read and coded. Codes were sorted into themes and sub-themes. Themes were reviewed and refined this included reflecting on the relationship between the themes and the meaning of the data as a whole. Themes were defined and named.

Reflexivity

In qualitative research, the researcher interacts closely with participants and reflexivity can affect the findings (33). A female British Pakistani MPharm student conducted the interviews and included a picture of herself on the IM accounts. The interviews were conducted under the supervision of an experienced mental health pharmacist and health psychologist (with experience of qualitative methods).

Results

Seventeen participants were recruited, of whom 9 completed an online interview (see table 1 for characteristics of the participants). Every participant opted to use Facebook. Data saturation was considered to have been achieved following an interim analysis (FA, IM) after the nine online interviews. It was decided that further online interviews would not provide further insights.

Table 1: Characteristics of participants

Participant Identifier:

Gender Age Location Ethnicity Name of Organisation

#A1 Male 35 Swansea (Wales)

White (British)

Mind

#A2 Female 25 York (England)

White (British)

Participant preferred not to disclose

#A3 Female 19 Lincoln (England)

White (British)

Participant preferred not to disclose

#A4 Female 22 Riyadh (Saudi Arabia)

White (British)

British Psychological Society

#A5 Male 36 Swansea (Wales)

White (British)

Mind

#A6 Male 33 Swansea (Wales)

White (British)

Participant preferred not to disclose

#A7 Female 23 Preston (England)

White (Other)

British Psychological Society

#A8 Female 44 Romford (England)

White (British)

Imagine Mental Health

#A9 Female 40 Swansea (Wales)

White (British)

Swansea Mind

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Table 2: Summary of participant demographic characteristics

Total number of participants

9

Number of females 6 Mean age (years) 30.8 Ethnicity White (British) (n= 8)

White (Other) (n=1)

The themes identified in the analysis were: Understanding of clinical trials, Considerations as to whether to take part in a clinical trial and the perceived risks attached to taking part in clinical trials.

Understanding of clinical trials

When questioned on the definition of clinical trials, the participants gave highly variable answers. Some participants provided a more detailed response regarding their understanding of the nature of a clinical trial:

“I think it means trials of medication that are not readily available to the public yet but have been tested thoroughly [sic] and the next step is to try out on the public to see how it goes. Whilst being monitored etc” (#A3)

“Well medical trials mean people given medication in controlled environment and told to report of the effects or side effects if any and if it helps or not, and one of the people involved will be on a placebo. Clinical trials might be the same if some medication is involved to, but I think with clinical trials you have the counselling side of it, like a clinic” (#A5)

“A trial of a new drug or therapy, where it is tested on a small number of people, to test safety/effectiveness. Taking a new medication and recording any side effects or symptoms in a diary” (#A1)

The scientific language and principles suggested in the above quotations demonstrates an appreciation of an understanding of clinical trials in more detail. However, other participants provided less detailed answers, suggesting less understanding:

“It's a trial of some sort” (#A6)

“Trying out people on medication…taking experimental new medication and noting the outcome” (#A9)

Some participants appeared to understand that within a clinical trial, the participants would be randomly allocated into groups where one group would receive the active medication and the other group would receive a placebo. As well as this, Participant 4 communicated that the trial is performed in animals first and then humans, suggesting a greater understanding of the fuller process regarding clinical trials:

“People are split into groups and some are given a placebo drug, some are given nothing and some get the trial medication” (#A8)

“When researchers test medications firstly on animals and then when they feel it is ready they trial it on humans with blind/double blind studies” (#A4)

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Whilst some participants identified that clinical trials include strict observations during the entire trial in order to identify any side-effects from the medication, some participants appeared to underestimate the risks:

“You apply and I assumed they would test you and make sure there is no danger to you then you would be assigned to a condition” (#A4)

Overall, participants’ responses demonstrated varied levels of understanding of clinical trials. Although some appeared to have sound knowledge, there was a general uncertainty as to what taking part in a clinical trial involves and the strict regulations that are involved in setting up such a test.

Considerations as to whether to take part in a clinical trial

Taking part in clinical trials was seen as an important and vital investment in order to aid the development and discovery of more effective treatments. Some of the participants expressed reasons that appeared to be of an altruistic nature for taking part:

“You’d feel you’d made a difference and helped towards new drugs” (#A3)

Participants expressed opinions that they would consider taking part in a trial under the following conditions: the trial was conducted in a safe environment; participants were monitored closely to ensure that everything was going well; no harm was being caused; it was convenient for them:

“They would need to monitor closely to check everything is going well and no harm is happening to the participants” (#A7)

The sense of potential threat involved in taking part in a clinical trial and the need to pay careful attention to the participant’s health and safety was communicated here.

Another important prerequisite for some participants was anonymity. Participants expressed concern over people becoming aware of their mental health problems. One participant commented that if they did not have to collect their medication from their local pharmacy, this would encourage them to take part in clinical trials:

“If I didn't have to collect the pills from my local chemist.... I go to a different chemist for my mad meds and I ask my daughter to pick them up for me because I don't want the pharmacy to know” (#A8)

This may suggest a level of embarrassment surrounding the implication of taking part in a clinical trial, and concern over what friends, acquaintances or healthcare professionals may think of them for taking part in a trial.

Participants were also more likely to participate in a clinical trial if the medication they were taking or had previous taken had had no effect:

“If the medication I tried didn’t work clinical trials would be an option…..it would make me feel good in a way, like there would be something else if everything else failed… if you have tried everything else you have nothing to lose” (#A4)

In addition to this, participants would be more inclined to take part in a clinical trial if they were suffering from a severe or terminal illness:

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“If I had a severe or terminal illness, and there was a new experimental drug or treatment, I might sign up, but in general I would probably be against it” (#A1)

The opinions of healthcare professionals were important to participants; it appeared that if the participant experienced a good relationship with their GP, they were more likely to consider participation in a trial:

“My GP, if they thought that it would be beneficial” (#A4)

This demonstrates that the level of trust an individual had in their healthcare professional would inform their decision although they would welcome a discussion about a trial:

“I would feel okay, like they were being pro-active. (They) had taken an interest in me and the approval of new treatments” (#A2)

In regards to the participant’s family and friends, all but two participants stated that they would be influenced by the views and opinions of their family and friends:

“My family………would definitely have a say in it, and to a lesser extent my friends. I think they would be cautious. My mum is very well informed……they would only support a decision if they thought it was in my best interest” (#A1)

However, others stated that the views of other people were less important:

“Other people's views don't really matter too much to me if I want to do something I normally do” (#A8)

Two participants knew someone else who had taken part in a clinical trial and had a positive view on participating in trials themselves:

“My daughter…. did take part…I was pleased that her GP was trying to get her health better…..and thankfully it has been a success for her” (#A8)

Overall, positive relationships with healthcare professionals, and successful experiences of clinical trials would encourage the participants to take part, as well as the rigid and thorough procedure of making sure the participant’s safety is paramount during the trial.

Perceived risks attached to taking part in clinical trials

Across the interviews, participants discussed their concerns about their beliefs of possible threats and side effects of taking part in a clinical trial. One issue concerned being part of a drug trial and the how successful the drug would be; as well as this the possible side effects of the drug would be calculated in the individual’s decision:

“Disadvantages are that the medicine might not work and make me more ill” (#A6)

“There could be some nasty side effects that no one is aware of that could cause long term damage” (#A4)

Participants expressed concerns that the experimental drug may not work which may cause their health to deteriorate. As well as this, the chance of the participants receiving a placebo made them question whether they would want to take part in a trial:

“The disadvantages are that it might just be a placebo” (#A1)

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Interviewees communicated a sense that taking part in a clinical trial can be unnerving and potentially expose participants to harm:

“It could be quite daunting and scary also if the trial doesn't go to plan the person could be badly affected or scarred mentally by the trial or it could go wrong” (#A3)

The sense that taking part in a clinical trial for participants would be overwhelming was communicated. On top of this, participants expressed concerns that taking part in a clinical trial may mean having to make changes to their medication:

“Disadvantages would be having to stop previous medication to meet requirements for participation” (#A2)

The degree to which taking part in a clinical trial would alter their normal daily living would be part of the decision making process:

“I would have to make sure it wouldn't affect me with my legal rights and my benefits” (#A5)

Participants were also concerned whether or not the investigational drug was compatible with their existing medication:

“I am currently on medication so would have to make sure it is compatible with what I am already taking” (#A5)

Some participants went on to say that because they have been diagnosed with a mental health condition they would feel more cautious about making changes to their medication, specifically because of their particular condition:

“If it was for a physical illness then I think I would, but if it's for mental illness I don't think I would because the side effects of these drugs (and I've had quite a few) are nasty… The disadvantages are it’s probably going to mess with my already messed up head…..” (#A8)

The symptoms of and the stigma associated with mental health problems also appeared to be a barrier. Interviewees mentioned that they did not want to risk a bad reaction to the experimental medication and have to be admitted to hospital:

“I would try it, depending on my condition” (#A7)

“I don't want other people to know I'm mentally ill so I wouldn't want to highlight my conditions by risking a bad reaction to the drug and being taken back to the mental hospital again” (#A8)

Participants emphasised the importance of remaining anonymous, as they did not want other people to know that they suffer from a mental health problem. Participants expressed worries about people finding out about their mental health problems, which discouraged them from taking part because this may lead to prejudice and discrimination due to the stereotypes associated with poor mental health:

“My own mental health would prevent me! If it was for a physical illness I'm sure I would but I am my own enemy in the way I don't want people to know I'm mentally ill so I would hide it as I do when I have to go out. I don't want to be judged crazy/mad

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.....People seem to think we're either gonna kill them or they fear us. When my illness was worse I saw this” (#A8)

Interviewees also mentioned that the symptoms of their mental health problem would discourage them or prevent them from taking part in clinical trials:

I don't like going out of the house much now so that could be a huge barrier! I would have to take someone with me because I'm still afraid to go out to far on my own without becoming really anxious (#A8)

As well as this, even if participants wished to take part in clinical trials, some participants expressed concerns that the exclusion criteria could prevent people with mental health problems from taking part in some clinical trials:

“I have seen a lot of clinical trials advertised that say you can’t take part if you suffer from depression and/or other mental illnesses but I guess in a clinical trial relating to that they would want some participants who do” (#A2)

The potential factors that are deliberated when considering taking part in clinical trials are multifaceted and involve a complex decision making process.

Discussion

Principal findings

NIHR policy documents have identified that recruitment to trials involving medication for mental health problems is likely to be more challenging than other areas, where unlike mental health patients may actively welcome the opportunity to try experimental treatments (38). This study found that the participants with mental health problems possess a variable level of understanding of what a clinical trial is and what taking part may involve. This research also found a number of factors that would influence the decision of someone with a mental health problem to participate in a CTIMP.

People with mental health problems feel worried about other people judging them because of their mental health problem so they try to keep their mental health condition hidden (1,2). Reflecting this stigma, this study found that fears associated with loss of anonymity inhibited participation in CTIMPs and led to patients developing ways to help protect their anonymity, such as not using local pharmacies. Patient-centred strategies to help maintain anonymity such as home delivery of trial medication could allay fears and encourage people with mental health problems to participate in clinical trials.

This study found that both safety and efficacy concerns may inhibit participation in CTIMPs. The risk of harmful side effects or the trial “going wrong” leading to long-term damage are significant barriers. This study did however find that if people with mental health problems are reassured of the safety of clinical trials and they are monitored very closely then this would encourage them to take part. Study participants expressed fears that the medication under investigation might not be effective causing their health to decline or that they might receive a placebo.

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Like previous research, this study found that people with mental health problems are less likely to take part in clinical trials if they were happy with their current medication and if participation means stopping their medication or reducing the dose due to fears of a re-lapse (25). This suggests that people will only participate if they are not satisfied with their current medication, for example if they are experiencing unpleasant side effects or if the medication is not working. Put another way people are only likely to participate if the perceived benefits outweigh the risks. However, if the trial mainly consists of people whose medication is not working for them then the sample may be biased and the results may not be generalizable to a wider population. Additionally, if the medication is not working then the potential trial participant may be unwell and lack mental capacity. In such circumstances the Medicines for Human Use (Clinical Trials) Regulations 2004 would need to apply (39). This need to take and confirm capacity to consent will increase the complexity and cost of CTIMPs in mental health (38). Limitations

The findings of this study are supported by previous research that found that people with mental health problems are less likely to take part in clinical trials (10-12,17), particularly if they are satisfied with their current medication (25). However, this study focussed on barriers within the UK, and may not necessarily be generalizable to people from other areas of the world such as Asia or Africa due to differences in culture, lifestyle and service provision. Recruitment to this study was challenging, previous research indicated that people with mental health problems are less likely to want to take part in mental health research (10-12), unfortunately this meant that they were also less likely to want to take part in this study. Of 17 participants recruited, only 9 completed an online interview. Previous research indicated that populations such as black and minority ethnic (BME) groups and women are less likely to take part in mental health research (17,26). The online interviews were relatively balanced across genders; it anything women were over-represented. However, despite active measures to recruit participants from BME backgrounds by contacting charities who worked with these groups and including a picture of the researcher (FA), who is from a British Pakistani background, no BME participants were recruited. Furthermore, the study only interviewed people who had access to a computer. Therefore the findings may not be generalizable across the entire UK population. Participants were not asked to disclose their actual diagnosis and we cannot be certain of the participant’s diagnosis. However, participants were mainly recruited through organisations which provide services directly or indirectly to people with mental health problems so it is likely that participants suffered from a serious mental health problem. Finally, reflexivity may have affected the responses; participants may have provided socially desirable responses.

Implications

The study identified barriers to recruiting people with mental health problems to CTIMPs; strategies can be devised to minimise these barriers and improve recruitment. Trials should be tailored to the needs of people with mental health problems, and reassurance provided that the trial is being conducted safely and their identity will be protected. People with mental

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health problems feel that they are not informed about clinical trials, and healthcare professionals could be trained to discuss research with patients, increasing awareness of research and improving recruitment. This strategy would also equip healthcare professionals to provide better support to their patients enrolled in clinical trials.

Future research

The findings of this study require confirmation and expansion which could be done by conducting further research using a larger sample size and participants from a wider geographical area. The method of recruitment used may have selected a particular sample. Future research should actively aim to recruit harder to reach participants with a broad range of views that reflects the views of the population (see appendix 7).

Future research should identify barriers faced by people from a BME background to identify any differences in this population. The JISC email list for minority and ethnic health (https://www.jiscmail.ac.uk/) may be a useful resource on strategies to engage people from a BME background. The views and opinions of the relatives and carers of people with mental health problems could also be explored to gain a wider perspective. Future research should be conducted to investigate strategies to minimise the barriers which have been identified and to improve recruitment.

Conclusion

This study found that people with mental health problems possess a variable level of understanding and knowledge of clinical trials. Barriers to participation included lack of capacity to consent, risk of side effects, unknown effects of the investigational drug, and having to stop current medication with potential relapse. The stigma associated with mental health problems appeared to be a significant barrier and requires further study. Facilitators included careful monitoring; support from healthcare professionals and family and friends encouraged people with mental health problems to take part in clinical trials. However, these results should be considered preliminary and require confirmation in other populations recruited by different methods.

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31. Stieger S, Göritz A. 2006. Using Instant Messaging for Internet-Based Interviews. CyberPsychology & Behavior, 9, 552-559. 32. Fontes T, O'Mahoney M. 2008. In-depth interviewing by Instant Messaging. Social Research Update, 53. 33. Tong A, Sainsbury P, Craig J. 2007. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19, 349-357. 34. The National Archives. Mental Capacity Act 2005 [Internet]. 2015 [cited 18 April 2015]. Available from: http://www.legislation.gov.uk/ukpga/2005/9/contents 35. Silverman, D 2013, Doing qualitative research, 4th edn, Sage, London. 36. Silverman, D 2011, Interpreting qualitative data, 4th edn, Sage, London. 37. Braun V, Clarke V. 2006. Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101. 38. Bell S, Wise J. 2007. The impact of the NHS R&D Strategy on Mental Health Services and Research in England – Report to the Department of Health. [cited 18 April 2016]. Available from: webarchive.nationalarchives.gov.uk/ 39. The Medicines for Human Use (Clinical Trials) Regulations No. 1031, 2004. [cited 18 April 2015]. Available from: http://www.legislation.gov.uk/uksi/2004/1031/pdfs/uksi_20041031_en.pdf

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Appendices

Appendix 1: Recruitment poster

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Appendix 2: List of organisations

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Appendix 3: Participant information sheet

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Appendix 4: Online consent form

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Appendix 5: Pre-interview briefing

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Appendix 6: Draft interview guide

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Appendix 7

After this project had been completed, Dr Ian Maidment met with Dr Pamela Lowe (Senior Lecturer in Sociology, Aston University) to discuss recruitment strategies for a possible future study. Dr Lowe stressed the importance of gaining trust of the potential participants and that this takes time. She recommended using pre-existing groups and working through a trusted person/gatekeeper; the gatekeeper could possibly facilitate or co-facilitate the interviews. Dr Lowe recommended asking the following questions - Whereabouts does the population spend time in the average day - when trying to identify venues where participants could be recruited. Possible organisations include local charities; community groups; hostels; homeless shelters; Big Issue Vendors; religious organisations (e.g. Salvation Army); and Drug and Alcohol services. The researcher should spend time within the organisations to gain trust. Once this trust is gained informal 10 minute interviews could be conducted; almost a drop-in type interview whilst the researcher is spending a day within the organisation. Alternatively, focus groups, which are empowering for participants, but more formal, could be conducted. Finally, Love-to-shop vouchers (£10 per participant) can be used to encourage participation.