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
Funders
Funder type
Government
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
-
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.
-
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.