Title: Prevention of long term social disability amongst young people with emerging signs of severe mental illness: A pilot randomised controlled trial of social recovery cognitive behaviour therapy for young people with emerging severe mental illness.
Funder: Department of Health (England)

Abstract: Design: The study will be a single blind pilot randomised controlled trial comprising of a 9 month intervention and 6 month follow up period involving 50 treatment cases and 50 controls in two centres. The study will constitute the feasibility phase undertaken in preparation for a large multicentre trial. A qualitative sub-study will be embedded within the pilot trial to evaluate the intervention from the subjective perspectives of patients themselves. The NIHR accredited Norfolk Clinical Trials Unit advised on the development of the protocol and will provide ongoing expertise during the conduct of the study. Setting: The intervention will be conducted in secondary mental health care settings by therapists based in outpatient youth mental health early detection and early intervention services in mental health trusts in East Anglia (Norfolk and Suffolk) and Manchester. Target population: Young people aged between 16-25 presenting with persisting signs of social disability and severe and complex mental health problems Health Technologies: Experimental: Multisystemic Social Recovery Cognitive Behavioural Therapy (MSRCBT). The intervention used will be an adaptation of the intervention used in our previous studies and described in our therapy manual (Fowler et al In Press). The intervention is delivered over 12 to 15 sessions (minimum of 6 sessions and maximum of 20 sessions) over a 9 month therapy window. It is designed for use in secondary early detection and intervention mental health services and differs substantially from currently available short term CBT available in adult mental health Improving Access to Psychological Therapies (IAPT) and CAMHS services. Control: The control condition is optimal treatment as usual. We will not be asking refers to withhold any treatment. Primary Outcome: Hours per week engaged in constructive economic and social activity. This assessment is derived from the Office of National Statistics Time Use Survey interview (Lader Short Gershuny 2006). and was successfully used as the primary outcome in our MRC trial platform study (Fowler et al 2009). Secondary outcomes: Psychotic symptoms (CAARMS;Yung Phillips et al. 2006). Depression: BDI II(Beck et al 1996).Health Economic outcomes: The Client Service Receipt Inventory (Thornicroft et al 2006). The EuroQol (EQ-5D; Brooks 1996). Sample size: 100. 50 treatment 50 controls. Project timetable: The study will take place over 30 months. This involves a 15 month recruitment period in which we can realistically expect a rate of 3-4 participants randomised per month in each site. Each participant will have a 9 month intervention and six month follow up. Recruitment will be monitored continuously via an independent DMEC.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH