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

Sussex Partnership NHS Foundation Trust0 个研究点目标入组 270 人开始时间: 2012年11月29日最近更新: 2022年2月7日

试验速览

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25431429 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28693622 results 2021 Funder report results in https://pubmed.ncbi.nlm.nih.gov/34842524/ (added 30/11/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35078555/ Clinical and cost-effectiveness results (added 27/01/2022)

•1. Young people (male & female) aged 16 to 25 with severe and complex mental health problems showing early signs of persistent social disability
•2. Presence of impairment in social and occupational functioning indicated by patterns of structured and constructive economic activity of less than 30 hours per week and a history of social impairment problems lasting for a period of longer than 6 months
•3. Presence of severe and complex mental health problems defined operationally as:
•3.1. Having attenuated psychotic symptoms which meet criteria for an At Risk Mental State; or
•3.2. Having less severe attenuated psychotic symptoms but having severe and complex mental health problems which score at least 50 on the Global Assessment of Function Scale (which indicates the presence of severe symptoms of at least two of depression, anxiety, substance misuse, behavioural or thinking problems or subthreshold psychosis to the degree to impair function).
•4. Also having a history of at least moderate symptoms persisting for longer than 6 months

•1. Age below 16 or above 25
•2. Active positive psychotic symptoms or history of first episode psychosis
•3. Severe learning disability (those with mild to moderate learning difficulties will not be excluded)
•4. Organic neurological disorder
•5. Unable to fully understand and answer standardised assessment questions or give informed consent due to insufficient English language proficiency

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