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
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
-
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.
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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.
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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.