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ISRCTN
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ISRCTN97313434
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DOI
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10.1186/ISRCTN97313434
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Prevention Of Parasuicide by Manual Assisted Cognitive-behavioural Therapy
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Scientific title
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Acronym
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POPMACT
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Serial number at source
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G9702283
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Study hypothesis
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To determine whether manual assisted cognitive behaviour therapy (MACT) is more effective than treatment as usual (TAU) in reducing the rate of episodes of deliberate self harm over a 12 month period
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Parasuicide
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Participants - inclusion criteria
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Patients presenting to the psychiatric services at any of five centres:
1. Southern General Hospital, Victoria Hospital and Stobhill Hospital in Glasgow
2. Royal Edinburgh Hospital, Edinburgh
3. Queen's Medical Centre, Nottingham
4. Chelsea and Westminster Hospital and St Mary's Hospital, West London
5. King's College Hospital, South London and Maidstone General Hospital, Kent
Patients will be included if they satisfy the following criteria:
1. Aged between 16 and 65
2. Have presented to an Accident & Emergency department after an episode of deliberate self-harm
3. They have had at least one other episode of deliberate self-harm previously
4. They give informed consent
Recruitment will take place over 20 months and randomisation of each patient will take place after all baseline assessments have been completed by the research assessor
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Participants - exclusion criteria
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1. Patients who do not have sufficient knowledge of English to enable them to be assessed adequately and to understand the treatment manual
2. Patients who are only temporary residents in the area concerned (e.g. foreign visitors, tertiary referrals with a permanent address elsewhere) who are unlikely to be available for follow-up (This does not necessarily include many people who are homeless but who come from the geographical area concerned; this group is at high risk of repeated episodes and constitutes around one in six of all parasuicide episodes and many will be included if they have established links in the geographical area)
3. Those with a diagnosis within the organic (F00 to F09), alcohol/drug dependence (F10 to F19), schizophrenia group (F20 to F29) or bipolar affective disorder (F31) (using the International Classification of Diseases [ICD-10] coding)
4. People who require psychiatric hospitalisation after their self-harm episode. Recruitment will take place over 20 months and randomisation of each patient will take place after all base-line assessments have been completed by the research assessor
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Anticipated start date
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01/12/1997
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Anticipated end date
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01/10/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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1. Manual assisted cognitive behaviour therapy (MACT)
2. Treatment as usual (TAU)
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Primary outcome measure(s)
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Rate of episodes of deliberate self-harm (using the Parasuicidal Acts Scale of Linehan) over the 12 month period
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Secondary outcome measure(s)
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1. Time to next episode of deliberate self-harm
2. Improvement in clinical symptoms (anxiety and depression) using the Hospital Anxiety and Depression Scale (HADS)
3. Change in social function (using the Social Functioning Questionnaire)
4. Cost of care
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Sources of funding
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UK Medical Research Council
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=15061347
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Contact name
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Professor
Peter
Tyrer
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Address
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Academic Department of Psychiatry
Imperial College School of Medicine
Paterson Centre
20 South Wharf Road
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City/town
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London
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Zip/Postcode
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W2 1PD
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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12/09/2007
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Date ISRCTN assigned
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23/10/2000
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