The London East Anglia randomised controlled trial for cognitive-behaviour therapy for psychosis: effects of the treatment phase

ISRCTN	ISRCTN42505388
DOI	https://doi.org/10.1186/ISRCTN42505388
Secondary identifying numbers	NMH13C

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 09/11/2022

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

Dr Elizabeth Kuipers
Scientific

Institute of Psychiatry
King's College
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7919 3242
Email	e.kuipers@iop.kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	The London East Anglia randomised controlled trial for cognitive-behaviour therapy for psychosis: effects of the treatment phase
Study objectives	A series of small, mainly uncontrolled, studies have suggested that techniques adapted from cognitive-behavioural therapy (CBT) for depression can improve outcome in psychosis, but no large randomised controlled trial of intensive treatment for medication-resistant symptoms of psychosis has previously been published.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Schizophrenia and other psychoses
Intervention	Participants randomised into the treatment group received up to nine months of individual cognitive behaviour therapy for psychosis. Sessions were conducted weekly initially, and then fortnightly. Participants randomised into standard care received routine care from their clinical team, which as part of the study entry criteria consisted of case management and medication.
Intervention type	Behavioural
Primary outcome measure	Measures were taken at baseline of demographic, clinical and cognitive variables. Changes over time were assessed on the Brief Psychiatric Rating Scale and the relationship between potential predictor variables and outcome was investigated using analysis of variance and covariance.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1993
Completion date	31/12/1997

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Total final enrolment	60
Key inclusion criteria	60 participants who each had one positive and distressing symptom of psychosis that was medication resistant (28 in a treatment group received a cognitive behaviour therapy and 32 a standard care only control condition).
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1993
Date of final enrolment	31/12/1997

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Psychiatry

London
SE5 8AF
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Mental Health National Research and Development Programme (UK)

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	Not provided at time of registration

Study outputs

Output type	Date created	Peer reviewed?	Patient-facing?
Results article	01/10/1997	Yes	No
Results article	01/11/1997	Yes	No
Results article	01/07/1998	Yes	No

Editorial Notes

09/11/2022: Total final enrolment added.