1. STEPWISE: STructured lifestyle Education for People WIth SchizophrEnia Chris Dickens, Professor of Psychological Medicine University of Exeter Medical School

2. 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 2

3. 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

4. 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 4

5. 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

6. 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

7. 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

8. 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

9. 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 9

10. 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 10

11. 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 11

12. Recruiting centres 12

13. 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 13

14. 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/m 2 or concern about weight gain since treatment initiation Weight at 1 year after entry to the trial 14

15. 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 15

16. Design of trial 16 Recruitment from clinical teams Baseline Assessment Randomisation 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 about diet, 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

17. Local teams Researchers and research administrators –1-day training Intervention facilitators (2 per centre) –3 day training to deliver Desmond intervention 17

18. Cornwall Stepwise team 18

19. 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 19

20. 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 rates 20

21. 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 21

22. Recruitment so far… SiteNumber Consented (overall) Number Randomised (overall) Manchester 4847 Devon 4442 Southern Health 4240 Bradford 2826 Cornwall 2421 Sussex 2221 Leeds & York 21 Somerset 2116 Sheffield 1615 SLaM 87 22

23. THANK YOU FOR YOUR ATTENTION 23