Condition category
Mental and Behavioural Disorders
Date applied
04/12/2007
Date assigned
27/03/2008
Last edited
14/09/2015
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

Prof Max Birchwood

ORCID ID

Contact details

School of Psychology
University of Birmingham
Early Intervention Service
1 Miller Street
Aston
Birmingham
B6 4NF
United Kingdom
+44 (0)121 301 1850
birchmjz@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MRC ref: G0500965

Study information

Scientific title

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

Acronym

COMMAND

Study hypothesis

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

West Midlands Multi-centre Research Ethics Committee, 05/01/2007, ref: 06/MRE07/71

Study design

Multicentre single-blind randomised controlled trial with intention to treat

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

17/09/2007

Overall trial end date

31/01/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180 (60 participants from each of the three site)

Participant 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

Recruitment start date

17/09/2007

Recruitment end date

31/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B6 4NF
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Research & Commercial Services
Aitchison Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
b.w.laverty@bham.ac.uk

Sponsor type

University/education

Website

http://www.bham.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21961763
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/26360400

Publication citations

  1. Protocol

    Birchwood M, Peters E, Tarrier N, Dunn G, Lewis S, Wykes T, Davies L, Lester H, Michail M, A multi-centre, randomised controlled trial of cognitive therapy to prevent harmful compliance with command hallucinations., BMC Psychiatry, 2011, 11, 155, doi: 10.1186/1471-244X-11-155.

  2. Results

    Birchwood M, Michail M, Meaden A, Tarrier N, Lewis S, Wykes T, Davies L, Dunn G, Peters E, Cognitive behaviour therapy to prevent harmful compliance with command hallucinations (COMMAND): a randomised controlled trial, Lancet Psychiatry, 2014 , 1, 1, 23-33, doi: 10.1016/S2215-0366(14)70247-0.

Additional files

Editorial Notes