Study Of Cognitive ReAlignment Therapy in Early Schizophrenia
ISRCTN | ISRCTN65818527 |
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DOI | https://doi.org/10.1186/ISRCTN65818527 |
Secondary identifying numbers | G9519373 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 23/09/2009
- 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 of protocol
Not provided at time of registration
Contact information
Professor SW Lewis
Scientific
Scientific
School of Psychiatry and Behavioural Science
University of Manchester
Withington Hospital
West Didsbury
Manchester
M20 8LR
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study acronym | SOCRATES |
Study objectives | To evaluate the effectiveness of cognitive behaviour therapy in parallel with drug treatments as usual in early acute schizophrenia. The hypothesis is that CBT is an acceptable adjunct to drug treatment which will accelerate resolution of target psychotic symptoms and reduce relapse. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Neurosciences, psychiatry |
Intervention | Cognitive behaviour therapy/drug treatments |
Intervention type | Other |
Primary outcome measure | 1. Change on core symptom scores on hallucination and delusion rating scales 2. Change in total symptoms scores on PANSS 3. Time to criterion of 50% recovery operationally defined - 4. Number of days in hospital before 1st discharge and during follow-up 5. Time to relapse 6. Follow-up symptom and outcome scores at 3.9 and 18 months |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/04/1996 |
Completion date | 31/03/2000 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Not Specified |
Target number of participants | 236 |
Key inclusion criteria | Consecutive sample of in- or day-patients admitted with 1st and 2nd episode schizophrenia aged 18-65. Further inclusion criteria: 1. Able to give informed consent 2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSMIV) diagnostic criteria for schizophrenia, schizophreniform or schizoaffective disorder with at least a 1 month history of positive symptoms 3. No significant history of organic brain disease or substance misuses for major aetiological factor for psychosis 4. Positive and negative syndrome scale (PANSS) for schizophrenia score of at least 4 on item hallucinatory behaviour and/or item delusions 5. Score of less than 5 on PANSS item conceptual disorganisation |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/04/1996 |
Date of final enrolment | 31/03/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Psychiatry and Behavioural Science
Manchester
M20 8LR
United Kingdom
M20 8LR
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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clinical.trial@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 | 01/09/2002 | Yes | No |