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21 May 2013
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| [ Print-friendly version ] |
| Psychological Prevention of Relapse in Psychosis |
| ISRCTN | ISRCTN83557988 |
| DOI | 10.1186/ISRCTN83557988 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Psychological Prevention of Relapse in Psychosis |
| Scientific title | A randomised controlled trial of cognitive behavioural therapy and family intervention for the prevention of relapse and reduction of symptoms in psychosis |
| Acronym | PRP |
| Serial number at source | 062452 |
| Study hypothesis |
The trial is designed to answer questions both about outcome and about mechanisms of treatment change of Cognitive Behaviour Therapy (CBT) and Family Intervention (FI) for psychosis. The trial consists of two pathways (for those with carers and those without) incorporating randomisation within each pathway, after stratification by treatment centre and whether the participant is an inpatient at the time of recruitment.
Trial I has two conditions: CBT and Treatment As Usual (TAU). Trial II has three conditions: CBT, FI and TAU. Primary Outcome hypotheses: 1. In Trial Pathway I, CBT will reduce rates of relapse and total days in hospital in the two year follow up compared to TAU, and that CBT will be cost neutral. 2. In Trial Pathway II, Both CBT and FI will reduce relapse and days in hospital at two year follow up compared with TAU, and that CBT and FI will be cost neutral. Secondary outcome hypotheses: 1. CBT and FI will both reduce relapse and psychotic and emotional symptoms at 12 months (end of treatment) compared with TAU. The main change in psychotic symptoms will be in delusions and hallucinations. 2. FI, but not CBT, will increase social functioning compared to TAU at 24 months. 3. CBT, but not FI, will reduce psychotic and emotional symptoms at 24 months compared with TAU. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Added 03/03/2009: South East Multi-Centre Research Ethics Committee gave approval on the 4th June 2001 (ref: MREC01/1/24). All local research ethics committees also subsequently approved the study. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Psychosis |
| Participants - inclusion criteria |
Participants are recruited from identified psychiatric teams in four NHS Trusts.
Entry criteria: 1. Current diagnosis of psychosis 2. Non-affective (International Statistical Classification of Diseases and Related Health Problems, Tenth edition [ICD-10], F20) 3. Aged 18 to 65 years, either sex 4. Second or subsequent episode, which started not more than three months before entry 5. Rated at least four (moderate severity) on the Positive and Negative Syndrome Scale (PANSS) on at least one positive psychotic symptom |
| Participants - exclusion criteria |
Added 03/03/2009:
1. Primary diagnosis of alcohol or substance dependency, organic syndrome or learning disability 2. Inadequate command of English to engage in psychological therapy 3. Unstable residential arrangements and so unlikely to be available for therapy and/or assessments over period of trial |
| Anticipated start date | 01/12/2001 |
| Anticipated end date | 31/10/2006 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 301 |
| Interventions |
For participants with carers:
1. Cognitive behavioural therapy (CBT) and treatment as usual (TAU) 2. Family intervention (FI) and TAU 3. TAU only For participants with no carers: 1. CBT and TAU 2. TAU only |
| Primary outcome measure(s) | Relapse and days in hospital over 24 months. |
| Secondary outcome measure(s) |
1. Pattern of symptom change (PANSS total scores and subscale scores, Psychotic SYmptom RATing Scales [PSYRATS], Beck Depression Inventory [BDI], Beck Anxiety Inventory [BAI]) over 12 and 24 months
2. Social functioning (time budget) at 24 months |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 062452) |
| Trial website | |
| Publications |
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16889588
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18515890 3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22499781 4. 2012 subgroup analysis results in http://www.ncbi.nlm.nih.gov/pubmed/21939591 5. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22499781 |
| Contact name | Prof Philippa Garety |
| Address |
Department of Psychology
PO Box 77 Institute of Psychiatry Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Tel | +44 (0)20 7848 0197 |
| Fax | +44 (0)20 7848 5006 |
| P.Garety@iop.kcl.ac.uk | |
| Sponsor | King's College London (UK) |
| Address |
Institute of Psychiatry
De Crespigny Park |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Tel | +44 (0)20 7848 0675 |
| Fax | +44 (0)20 7848 0147 |
| g.dale@iop.kcl.ac.uk | |
| Sponsor website: | http://www.iop.kcl.ac.uk |
| Date applied | 25/06/2003 |
| Last edited | 19/04/2013 |
| Date ISRCTN assigned | 25/06/2003 |
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