Study Of Cognitive ReAlignment Therapy in Early Schizophrenia

ISRCTN	ISRCTN65818527
DOI	https://doi.org/10.1186/ISRCTN65818527
Secondary identifying numbers	G9519373

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Professor SW Lewis
Scientific

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

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

School of Psychiatry and Behavioural Science

Manchester
M20 8LR
United Kingdom

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

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

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2002		Yes	No