Psychological Prevention of Relapse in Psychosis
| ISRCTN | ISRCTN83557988 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83557988 |
| Secondary identifying numbers | 062452 |
- Submission date
- 25/06/2003
- Registration date
- 25/06/2003
- Last edited
- 19/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Philippa Garety
Scientific
Scientific
Department of Psychology
PO Box 77
Institute of Psychiatry
Denmark Hill
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0197 |
|---|---|
| P.Garety@iop.kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of cognitive behavioural therapy and family intervention for the prevention of relapse and reduction of symptoms in psychosis |
| Study acronym | PRP |
| 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. |
| Ethics approval(s) | 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. |
| Condition | Psychosis |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | Relapse and days in hospital over 24 months. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2001 |
| Overall study end date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 301 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/12/2001 |
| Recruitment end date | 31/10/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Psychology
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0)20 7848 0675 |
|---|---|
| g.dale@iop.kcl.ac.uk | |
| Website | http://www.iop.kcl.ac.uk |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 062452)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2006 | Yes | No | |
| Results article | results | 01/06/2008 | Yes | No | |
| Results article | subgroup analysis results | 01/05/2012 | Yes | No | |
| Results article | results | 01/05/2013 | Yes | No | |
| Results article | results | 01/05/2013 | Yes | No |
