STEPWISE: STructured lifestyle Education for People WIth

SchizophrEnia

Chris Dickens,Professor of Psychological MedicineUniversity of Exeter Medical School

STEPWISE project• Randomised controlled trial (how effective?)

• Lifestyle intervention based on DESMOND intervention

– For people with schizophrenia, schizo-affective disorder, first onset psychosis

• Funded by the NIHR. Hosted by University of Sheffield Clinical Trials Research Unit

• Chief Investigator, Richard IG Holt, Professor in Diabetes & Endocrinology, University of Southampton

• Local Principal Investigator:– Cornwall, Richard Laugharne, – Devon, Chris Dickens– Somerset, Andy Harewood

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Schizophrenia• A long-term mental health condition

– (severe and enduring mental illness)

• Range of different symptoms, including: – Hallucinations

• hearing or seeing things that do not exist – Delusions 

• unusual beliefs not based on reality that often contradict the evidence

– Muddled thoughts based on hallucinations or delusions– Changes in behaviour

• Affect 1 in every 100 people

• Range of treatment options, but commonly involves antipsychotic medication 3

Schizo-affective disorder• A long-term mental health condition (severe enduring

mental illness)

• Affects about 1 person in every 300

• Shares many of the feature of schizophrenia

• In addition, prominent disturbances of mood are a feature

• Range of treatment options including:

– Antipsychotics

– Antidepressants

– Mood stabilising medication 

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Physical Consequences of Severe Mental Illness

• Mortality increased 2.5-3x compared to general population

• Life expectancy is reduced by 10-20 years

• 75% of patients die from natural causes

– 33-60% die from CVD

Brown et al Br J Psychiatry. 2010 Feb;196(2):116-21 Osby Arch Gen Psychiatry. 2001 Sep;58(9):844-50

Causes of increased mortality

• Obesity is a risk factor for vascular disease

– Obesity v common in people with schizophrenia

– Approx 40-50% are obese compared to 20 to 30% in general population

• Causes of obesity in schizophrenia are complex

– Antipsychotic medication is linked to obesity

– Effects of antipsychotics on weight are very quick with majority of effect happening in first 3 months

NICE quality standard Feb 2015:Psychosis and schizophrenia in

adults• Quality statement 6:

– Evidence of local arrangements that adults with psychosis or schizophrenia have specific comprehensive physical health assessments

• Within 3 months of first starting treatment• 12 monthly thereafter

NICE quality standard Feb 2015:Psychosis and schizophrenia in

adults• Quality statement 7:

– Evidence of local arrangements that adults with psychosis or schizophrenia are offered combined healthy eating and physical activity programmes, and help to stop smoking

• Proportion who receive combined healthy eating and physical activity programmes in past 12 months

• Proportion of smokers who receive help to stop smoking within the past 12 months

Current research evidence

• We know that weight loss interventions are effective in people with schizophrenia,

• However

– Most studies are less than 3-6 months in duration

– Few studies in first episode psychosis

– No long term follow-up

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STEPWISE: STructured lifestyle Education for People WIth SchizophrEnia • 4 year project funded by HTA aiming to:

– In people with schizophrenia, schizoaffective disorder or first episode psychosis

– Evaluate the extent to which a structured lifestyle education programme delivered t, can support weight loss

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STEPWISE objectives• Adaptation of DESMOND intervention

– to make it more appropriate for and acceptable for mental health services

– to provide a greater focus on weight loss

• Undertake a multicentre randomised controlled trial to evaluate clinical and cost effectiveness of lifestyle intervention

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Recruiting centres

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STEPWISE Intervention• Structured education programme

• Delivered by two trained facilitators

• 4 x 2.5 hour (weekly) sessions – including lunch and breaks

– Focuses on diet and physical activity

• ‘support contact’ (1:1 personalised 10 min conversation) provided approx. every 2 weeks

• ‘booster’ (group) sessions at month 4, 7 and 10 (post-randomisation

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Participant characteristics• Age ≥18 years old with no upper age limit

• A diagnosis of a schizophrenia or schizoaffective disorder

• Treatment with an antipsychotic for >1 month

• Body mass index ≥25 kg/m2 or concern about weight gain since treatment initiation

• Weight at 1 year after entry to the trial14

Numbers involved

• 412 participants (206 per arm)

– 40-50 participants per centre

– 20-25 of whom will receive the intervention in 3 or 4 groups

• Powered for a 5% difference in body weight at 12 months allowing for a 20% drop-out

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Design of trial

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Recruitment from clinical teams

Baseline AssessmentRandomisation

Control Intervention:(n=206, 1:1, delivered by CMHT)

* Physical Health Review (per NICE guidelines)

* Verbal and printed advice on the risk of weight gain

lifestyle advice, including information aboutdiet, exercise, smoking and alcohol use.

Research Intervention:(n=206, in 26-34 facilitated groups of 6-8

people at 10 Mental Health Trusts)Group lifestyle programme and educator training

protocol to promote behaviour change* 4 x 1-hr weekly sessions†

* “booster” sessions at 4, 7 and 10 months

12 month Assessment

3 month Assessment

Local teams• Researchers and research administrators

– 1-day training

• Intervention facilitators (2 per centre)

– 3 day training to deliver Desmond intervention

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Cornwall Stepwise team

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Progress so far

• Facilitators trained in April 2015

– 2 Cornwall,

– 2 in Somerset and

– 6 in Devon (North Devon, South Devon and Exeter teams)

• Recruitment able to start from May 2015 for 12 months

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Experiences to date

Good

• Immense efforts from the research teams

– Really intensive assessments

– A lot of travelling

• Really good engagement from clinical teams

– Support for the trial

– recruitment

• Really good engagement with service users

– Its been a really easy sell

• Excellent feedback from facilitators and service users

• Excellent follow-up rates20

Experiences to date

Challenges

• Geographic challenges

– Considerable distances to travel for staff and service users

• Transport issues

– Unruly taxi companies

– High transport costs

• Staffing challenges

– Maintaining facilitators

– Organisations move staff around

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Recruitment so far…Site Number Consented 

(overall)Number Randomised

(overall)

Manchester 48 47Devon 44 42Southern Health

42 40

Bradford 28 26Cornwall 24 21Sussex 22 21Leeds & York 21 21Somerset 21 16Sheffield 16 15SLaM 8 7

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THANK YOU FOR YOUR ATTENTION

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