PRODIGY (Definitive RCT): Version 1
Research type
Research Study
Full title
PRODIGY: Prevention of long term social disability amongst young people with emerging psychological difficulties: a definitive randomised controlled trial of social recovery cognitive behavioural therapy.
IRAS ID
185153
Contact name
David Fowler
Contact email
Sponsor organisation
Sussex Partnership NHS Foundation Trust
ISRCTN Number
ISRCTN47998710
Duration of Study in the UK
3 years, 4 months, 0 days
Research summary
Objectives - The aim of the study is to undertake a definitive randomised trial to determine the relative clinical and cost-effectiveness of Social Recovery Cognitive Behaviour Therapy (SRCBT) compared to Enhanced Standard Care (ESC) in young people who present with social disability 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 control trial comparing standard care with standard care plus Social Recovery Cognitive Behavioural Therapy. Participants will be stratified by site, age, severity of social disability, and symptomatic criteria and randomised to treatment groups by a remote randomisation service applying a method of concealed allocation. The intervention will last for 9 months with assessments at baseline, 9 months, 15 months and 24 months. Participants will be recruited from early detection and youth services in Sussex, East Anglia and Manchester over a 30 month period.
Participants - We will recruit 170 people aged 16 to 25 years who present to youth services 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).
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0590
Date of REC Opinion
29 Jul 2015
REC opinion
Favourable Opinion