PRODIGY: Prevention and treatment of long term social disability amongst young people with emerging severe mental illness: A randomised controlled trial
Recipient organisationSussex Partnership NHS Foundation Trust
Funding£1.4M
PeriodSept 2015 — May 2019
In plain English
AI plain-English summary
A quarter of young people referred to mental health services are spending fewer than 30 hours a week in any structured activity—work, study, or social contact—and standard care is failing to get them back on track. This matters because prolonged social withdrawal in adolescence and early adulthood often hardens into long-term disability, trapping people outside education, employment, and relationships. Existing treatments for severe non-psychotic mental health problems rarely target social functioning directly, so clinicians lack evidence on whether a specialised talking therapy can reverse this trajectory. The trial will test Social Recovery Cognitive Behavioural Therapy against enhanced standard care in 270 participants aged 16–25 across three English centres. If the therapy proves effective, it would give mental health services a manualised, costed intervention that measurably increases hours of constructive activity—a concrete outcome that affects whether a young person can hold a job, finish a course, or maintain friendships. The health economic analysis will tell funders whether the gains justify the cost. Without this trial, services will continue offering generic support that may not address the core problem of social disability.
View original technical description
Aims: To undertake a definitive randomised trial to determine the relative clinical and cost-effectiveness of social recovery cognitive behaviour therapy compared to enhanced standard care in young people who present with social withdrawal and severe and complex non-psychotic mental health problems and who are at risk of long term social disability and mental illness. Design: The study will be a single blind, randomised controlled definitive treatment trial comprising of a 9 month intervention and 15 month follow up period involving 270 participants, 135 treatment cases and 135 controls in three centres. Setting: The setting will be secondary mental health care early intervention and youth mental health services in mental health trusts in Sussex, Manchester and East Anglia. Participants: Young people aged between 16-25 presenting with persisting signs of social disability operationally defined as engaged in less than 30 hours structured activity per week and who are presenting to youth services in East Anglia, Sussex and Manchester and presenting with severe and complex mental health problems. Health technologies: Experimental: Social Recovery Cognitive Behavioural Therapy (SRCBT). The intervention used will be as described in our therapy manual (Fowler et al, 2013). Control: Enhanced Standard Care. We standardise and enhance current practice by providing all referrers in both arms with a best practice manual for standard treatment which summarises good practice including referral and medication management where appropriate. Measurement of outcomes and costs: Primary Outcome: Hours per week engaged in constructive economic and social activity (Time use) at 15 months. This assessment of social functioning is derived from the Office of National Statistics Time Use Survey interview (Lader et al, 2006). This is an established measure used in several previous studies which show good reliability and internal consistency ICC and sensitivity for use as primary outcome (Fowler et al, 2009). Secondary outcomes: The Clinical Assessment of At Risk Mental States (CAARMS) (Yung, Phillips, et al., 2006) will be used to assess attenuated psychotic symptoms and associated psychopathology, drug usage and risk to self and others by mental state interview. Primary and secondary outcomes are assessed at 9 months (post treatment), and 15 and 24 months post randomisation. The Health Service Resource Use Questionnaire (HSRUQ) (Thornicroft et al., 2006) is used to assess service use and costs. The HSRUQ and the EQ-5D (Brooks, 1996) will be the main assessments used for the health economic analysis. Sample size: 90% statistical power can be achieved through recruiting 270 analysable participants, randomised 1:1, recruited across 3 clinical centres to detect a minimally clinically significant difference in the primary outcome of 0.4. Project timetable: 100 participants have already been recruited as an internal pilot stage. A definitive trial will be completed by recruiting a further 170 participants over 2.5 years (30 months).
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