A randomised controlled trial of cognitive therapy for command hallucinations

ISRCTN	ISRCTN42620357
DOI	https://doi.org/10.1186/ISRCTN42620357
Protocol serial number	RGC00391
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive West Midlands (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Peter Trower
Scientific

University of Birmingham / South Bham Mental Health Trust
Queen Elizabeth Psychiatric Hospital
Mindelsohn Way
Birmingham
B15 2TT
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Schizophrenia and other psychoses
Intervention	1. Cognitive therapy 2. Control
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/2001

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	52
Key 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.
Key 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.
Date of first enrolment	01/10/1999
Date of final enrolment	01/10/2001

University of Birmingham / South Bham Mental Health Trust

Birmingham
B15 2TT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2004		Yes	No