Title: PRODIGY: Prevention and treatment of long term social disability amongst young people with emerging severe mental illness: A randomised controlled trial
Funder: Department of Health and Social Care

Abstract: 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).

Lay abstract: It is now known that the most serious mental health problems begin in the teenage and young adulthood. Some young people who experience mental health problems sometimes find it hard to carry on living the life they want to live; for example, having problems going to work or college, or taking part in social activities. These social and mental health problems are often very distressing for young people and their families at the time. Experiencing these problems also increases the risk of long-term social and mental health problems. Despite these potential immediate and long-term problems, these young people and their families often do not often access the treatment they need from mental health services. There is a major gap in identifying mental health problems of young people and providing appropriate and effective support to help with social recovery. 'Social recovery' is a term used to describe when someone is living the life they want to despite having experienced mental health problems. We think that people might make a better social recovery if they work with a therapist using a technique called Social Recovery Cognitive Behavioural Therapy (SRCBT). This is a talking therapy which helps young people to identify their interests and goals and what might be making it more difficult for them to do the kinds of activities they value. The therapist also helps the young person to overcome these barriers and feel less worried about starting new activities or engaging again in things they used to enjoy. Research we have already done suggests that SRCBT helps with meaningful activity and mental health for people with psychosis (for example, hear voices and feeling threatened by others). This project will test how helpful it is to provide this type of therapy to socially withdrawn young people at earlier stages of mental health problems. We have conducted a successful pilot in which 100 young people participated. We are going to recruit another 170 young people in Sussex, East Anglia and Manchester with severe and complex mental health problems and who have associated social disability (defined as 30 hours a week or less spent participating in structured activity). To help us find out how beneficial SRCBT is, we need to compare it to the care and support young people currently get. In order to do this, we will randomly put young people who take part into two groups: one group will receive the SRCBT and the other group will not. The SRCBT lasts for 9 months. Young people complete assessments at the beginning of the study, after 9 months, after 15 months and after 24 months. These assessments help us to understand whether the SRCBT seems to be helpful for young people’s social recovery and mental health. We have also been asking young people to tell us their perspectives about SRCBT and the experience of taking part in the project. The results of this research study will inform future guidance for patient care. The study will also provide important evidence for interventions aimed at preventing mental health problems.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH