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

ISRCTN ISRCTN62304114
DOI https://doi.org/10.1186/ISRCTN62304114
Secondary identifying numbers MRC ref: G0500965
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

Study designMulticentre single-blind randomised controlled trial with intention to treat
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA multicentre, randomised controlled trial of cognitive therapy to reduce harmful compliance with command hallucinations
Study acronymCOMMAND
Study objectivesMain 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) studiedCommand hallucinations
InterventionThree 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 typeOther
Primary outcome measureCompliance 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 measuresBeliefs 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 study start date17/09/2007
Completion date31/01/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants180 (60 participants from each of the three site)
Total final enrolment197
Key inclusion criteria1. 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 criteria1. 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 enrolment17/09/2007
Date of final enrolment31/01/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Birmingham
Birmingham
B6 4NF
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Research & Commercial Services
Aitchison Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Phone +44 (0)121 414 7618
Email b.w.laverty@bham.ac.uk
Website http://www.bham.ac.uk
ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Government

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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