A multicentre, randomised controlled trial of cognitive therapy to reduce harmful compliance with command hallucinations

ISRCTN	ISRCTN62304114
DOI	https://doi.org/10.1186/ISRCTN62304114
Protocol serial number	MRC ref: G0500965
Sponsor	University of Birmingham (UK)
Funder	Medical Research Council (UK)

Submission date: 04/12/2007
Registration date: 27/03/2008
Last edited: 18/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Max Birchwood
Scientific

School of Psychology
University of Birmingham
Early Intervention Service
1 Miller Street
Aston
Birmingham
B6 4NF
United Kingdom

Phone	+44 (0)121 301 1850
Email	birchmjz@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre single-blind randomised controlled trial with intention to treat
Secondary study design	Randomised controlled trial
Scientific title	A multicentre, randomised controlled trial of cognitive therapy to reduce harmful compliance with command hallucinations
Study acronym	COMMAND
Study objectives	Main hypothesis: The group receiving the cognitive therapy (CTCH group) will show a lower level of compliance and appeasement behaviour and an increase in resistance compared with the control group Secondary hypotheses: The CTCH group will show lower levels of conviction in the power of the voice and reduction in distress and depression compared to the control group Publication from pilot study: http://www.ncbi.nlm.nih.gov/pubmed/15056575 More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0500965&CaseId=5966
Ethics approval(s)	West Midlands Multi-centre Research Ethics Committee, 05/01/2007, ref: 06/MRE07/71
Health condition(s) or problem(s) studied	Command hallucinations
Intervention	Three UK sites will be taking part: Birmingham, London and Manchester. Participants will be randomly allocated to two groups: 1. Cognitive Therapy for Command Hallucinations + Treatment As Usual (CTCH + TAU) 2. TAU only The CTCH + TAU group will receive an average of 15 sessions (maximum 25 sessions in all) of cognitive therapy delivered by qualified clinical psychologists who will be regularly supervised by consultant psychologists. This cognitive therapy uses Cognitive Behavioural Therapy (CBT) to assess and modify conviction in four beliefs linked to the construct of voice power: i) that the voice has absolute power and control; ii) that the client must comply or appease or be severely punished; iii) the identity of the voice (e.g. the Devil) and iv) the meaning attached to the voice experience (e.g., the client is being punished for past bad behaviour).
Intervention type	Other
Primary outcome measure(s)	Compliance behaviour, assessed using the Cognitive Assessment of Voices Interview Schedule combined with the Revised Voice Compliance Scale. This is an observer rated scale to measure the level of compliance/resistance with each command, using information from the participant and at least one of three other informants (parent, spouse, keyworker). Each behaviour is then classified as: 1. Neither appeasement nor compliant 2. Symbolic appeasement, i.e. compliant with innocuous and/or harmless commands 3. Actual appeasement i.e. preparatory acts or gestures 4. Partial compliance with at least one severe command 5. Full compliance with at least one severe command The ratings are taken at baseline, 9 and 18 months.
Key secondary outcome measure(s)	Beliefs about voices, distress and symptoms assessed at baseline, 9 and 18 months follow-up as follows: 1. Voice power is measured using the Voice Power Differential Scale (VPD) which measures the power differential between voice and voice hearer 2. Distress associated with delusions about voices is measured using the Psychotic Symptoms Rating Scales (PSYRATS) 3. Psychosis symptoms are rated using the Positive and Negative Symptom Scale (PANSS) 4. Beck Hopelessness scale & Beck Scale for Suicidal Ideation 5. Calgary Depression Scale 6. Personal Knowledge Questionnaire 7. Beliefs about voice questionnaire 8. Suicide and self-injury scale (SASII) 9. Childhood trauma questionnaire
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	180
Total final enrolment	197
Key inclusion criteria	1. Aged 16-65 2. Primary diagnosis of International Statistical Classification of Diseases and Related Health Problems (ICD-10) schizophrenia or related disorder 3. History of experiencing command hallucinations (minimum 6 months) with risk of harm to self or others
Key exclusion criteria	1. Over 65 years of age 2. Primary diagnosis of organic brain disorder 3. Primary diagnosis of addictive substance misuse 4. Insufficient command of the English language
Date of first enrolment	17/09/2007
Date of final enrolment	31/01/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Birmingham

Birmingham
B6 4NF
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2014		Yes	No
Results article	results	15/06/2018	18/10/2019	Yes	No
Protocol article	protocol	30/09/2011		Yes	No

Editorial Notes

18/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.