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07 August 2008
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| [ Print-friendly version ] |
| A multicentre, randomised controlled trial of cognitive therapy to reduce harmful compliance with command hallucinations |
| ISRCTN | ISRCTN62304114 |
| ClinicalTrials.gov identifier | |
| Public title | A multicentre, randomised controlled trial of cognitive therapy to reduce harmful compliance with command hallucinations |
| Scientific title | |
| Acronym | COMMAND |
| Serial number at source | MRC ref: G0500965 |
| 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/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15056575 |
| Ethics approval | The trial was approved by the West Midlands Multi-centre Research Ethics Committee on the 5th of January 2007 (ref: 06/MRE07/71) |
| Study design | Multi-centre, single-blind, randomised controlled trial with intention to treat. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Command hallucinations |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 17/09/2007 |
| Anticipated end date | 31/01/2011 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 180 (60 participants from each of the three site) |
| Interventions |
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). |
| 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. |
| 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 |
| Sources of funding | Medical Research Council (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Max Birchwood |
| Address |
School of Psychology
University of Birmingham Early Intervention Service 1 Miller Street Aston |
| City/town | Birmingham |
| Zip/Postcode | B6 4NF |
| Country | United Kingdom |
| Tel | +44 (0)121 301 1850 |
| Fax | +44 (0)121 301 1851 |
| birchmjz@bham.ac.uk | |
| Sponsor | University of Birmingham (UK) |
| Address |
Research & Commercial Services
Aitchison Building University of Birmingham Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Tel | +44 (0)121 414 7618 |
| b.w.laverty@bham.ac.uk | |
| Sponsor website: | http://www.bham.ac.uk |
| Date applied | 04/12/2007 |
| Last edited | 28/04/2008 |
| Date ISRCTN assigned | 27/03/2008 |
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