Study Of Cognitive ReAlignment Therapy in Early Schizophrenia

ISRCTN ISRCTN65818527
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

School of Psychiatry and Behavioural Science
University of Manchester
Withington Hospital
West Didsbury
Manchester
M20 8LR
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymSOCRATES
Study objectivesTo 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) studiedNeurosciences, psychiatry
InterventionCognitive behaviour therapy/drug treatments
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/04/1996
Completion date31/03/2000

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexNot Specified
Target number of participants236
Key inclusion criteriaConsecutive 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 criteriaNot provided at time of registration
Date of first enrolment01/04/1996
Date of final enrolment31/03/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Psychiatry and Behavioural Science
Manchester
M20 8LR
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email 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
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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