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Open Access Study protocol

A multi-centre, randomised controlled trial of cognitive therapy to prevent harmful compliance with command hallucinations

Max Birchwood1*, Emmanuelle Peters25, Nicholas Tarrier2, Graham Dunn3, Shon Lewis3, Til Wykes25, Linda Davies3, Helen Lester4 and Maria Michail1

Author Affiliations

1 School of Psychology, University of Birmingham, Edgbaston, B15 2TT, Birmingham, UK

2 King's College London, Institute of Psychiatry, Psychology Department, De Crespigny Park, London, SE5 8AF, UK

3 School of Community Based Medicine, University of Manchester, Oxford Road, Manchester, M13 9PT, UK

4 Primary Care Clinical Sciences, School of Health and Population Sciences, Primary Care Clinical Sciences Building, University of Birmingham, Edgbaston, B15 2TT, Birmingham, UK

5 NIHR Biomedical Research Centre for Mental Health, South London and Maudsley NHS Foundation Trust, UK

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BMC Psychiatry 2011, 11:155  doi:10.1186/1471-244X-11-155

Published: 30 September 2011

Abstract

Background

Command hallucinations are among the most distressing, high risk and treatment resistant symptoms for people with psychosis; however, currently, there are no evidence-based treatment options available for this group. A cognitive therapy grounded in the principles of the Social Rank Theory, is being evaluated in terms of its effectiveness in reducing harmful compliance with command hallucinations.

Methods/Design

This is a single blind, intention-to-treat, multi-centre, randomized controlled trial comparing Cognitive Therapy for Command Hallucinations + Treatment as Usual with Treatment as Usual alone. Eligible participants have to fulfil the following inclusion criteria: i) ≥16 years; ii) ICD-10 diagnosis of schizophrenia or related disorder; iii) command hallucinations for at least 6 months leading to risk of harm to self or others. Following the completion of baseline assessments, eligible participants will be randomly allocated to either the Cognitive Therapy for Command Hallucinations + Treatment as Usual group or the Treatment as Usual group. Outcome will be assessed at 9 and 18 months post randomization with assessors blind to treatment allocation. The primary outcome is compliance behaviour and secondary outcomes include beliefs about voices' power, distress, psychotic symptoms together with a health economic evaluation. Qualitative interviews with services users will explore the acceptability of Cognitive Therapy for Command Hallucinations.

Discussion

Cognitive behaviour therapy is recommended for people with psychosis; however, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms. In this trial, however, the focus of the cognitive behavioural intervention is on individuals' appraisals, behaviour and affect and not necessarily symptoms; this is also reflected in the outcome measures used. If successful, the results will mark a significant breakthrough in the evidence base for service users and clinicians and will provide a treatment option for this group where none currently exist. The trial will open the way for further breakthrough work with the 'high risk' population of individuals with psychosis, which we would intend to pursue.

Trial registration

ISRCTN: ISRCTN62304114