A multicentre, randomised controlled trial of cognitive therapy to reduce harmful compliance with command hallucinations
ISRCTN | ISRCTN62304114 |
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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
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 |
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birchmjz@bham.ac.uk |
Study information
Study design | Multicentre single-blind randomised controlled trial with intention to treat |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 17/09/2007 |
Completion date | 31/01/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 180 (60 participants from each of the three site) |
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
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B6 4NF
United Kingdom
B6 4NF
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Research & Commercial Services
Aitchison Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
Phone | +44 (0)121 414 7618 |
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b.w.laverty@bham.ac.uk | |
Website | http://www.bham.ac.uk |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Medical Research Council (UK)
Government organisation / National government
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.