Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/01/2010
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 Peter Trower

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes