Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGC00391
Study information
Scientific title
Acronym
Study hypothesis
The objective is to evaluate whether a form of cognitive therapy (CT) developed by the applicants is an effective form of treatment for command hallucinations. The researcher's cognitive model asserts that high risk behaviours of command hallucinators are a consequence of core beliefs, namely a conviction in the power of their voices and a belief that they are compelled to comply with and appease these voices.
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
1. Cognitive therapy
2. Control
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Voices:
1.1. Content - Cognitive Assessment Schedule (Chadwick & Birchwood, 1995)
1.2. Topograph - Frequency, volume, audibility, affect (Hustig & Hafner, 1992)
1.3. Beliefs and evidence
1.3.1. Beliefs About Voices Questionnaire (Chadwick & Birchwood, 1995)
1.3.2. Maudsley Assessment of Delusions Schedule (Buchanan et al 1993)
1.4. Compliance (Beck-Sander et al 1997)
2. Affect:
2.1. Depression, hopelessness (Calgary Depression Scale for Schizophrenia: Addington & Addington, 1993)
3. Mental State:
3.1. Positive and Negative Syndrome Scale (PANSS) (Kay, 1997)
3.2. Previous episodes of 'risk' behaviours
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1999
Overall trial end date
01/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
The sample will be drawn from the case registers of patients receiving treatment from South and North Birmingham Mental Health Trusts. From this sample base the researchers will draw a cohort of patients conforming to International Statistical Classification of Diseases and Related Health Problems, Tenth revision (ICD-10) schizophrenia who have experienced auditory command hallucinations for a minimum of six months. There will 26 patients in each of the groups.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
52
Participant exclusion criteria
1. Current drug and alcohol misuses
2. Primary organic disorder
This is to ensure that the auditory hallucinations are a symptom of schizophrenia rather than induced by drugs or the result of organic impairment.
Recruitment start date
01/10/1999
Recruitment end date
01/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham / South Bham Mental Health Trust
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive West Midlands (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
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15056575
Publication citations
-
Results
Trower P, Birchwood M, Meaden A, Byrne S, Nelson A, Ross K, Cognitive therapy for command hallucinations: randomised controlled trial., Br J Psychiatry, 2004, 184, 312-320.