Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Kuipers

ORCID ID

Contact details

Institute of Psychiatry
King's College
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7919 3242
e.kuipers@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NMH13C

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/1993

Overall trial end date

31/12/1997

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1993

Recruitment end date

31/12/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Mental Health National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/9850205 (Follow-up and economic evaluation at 18 months)
2. http://www.ncbi.nlm.nih.gov/pubmed/9463599 (predictors of outcome)
3. http://www.ncbi.nlm.nih.gov/pubmed/9373419 (effects of the treatment phase)

Publication citations

  1. Kuipers E, Fowler D, Garety P, Chisholm D, Freeman D, Dunn G, Bebbington P, Hadley C, London-east Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis. III: Follow-up and economic evaluation at 18 months., Br J Psychiatry, 1998, 173, 61-68.

  2. Garety P, Fowler D, Kuipers E, Freeman D, Dunn G, Bebbington P, Hadley C, Jones S, London-East Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis. II: Predictors of outcome., Br J Psychiatry, 1997, 171, 420-426.

  3. Kuipers E, Garety P, Fowler D, Dunn G, Bebbington P, Freeman D, Hadley C, London-East Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis. I: effects of the treatment phase., Br J Psychiatry, 1997, 171, 319-327.

Additional files

Editorial Notes