Prevention Of Parasuicide by Manual Assisted Cognitive-behavioural Therapy

ISRCTN ISRCTN97313434
DOI https://doi.org/10.1186/ISRCTN97313434
Secondary identifying numbers G9702283
Submission date
23/10/2000
Registration date
23/10/2000
Last edited
12/09/2007
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

Professor Peter Tyrer
Scientific

Academic Department of Psychiatry
Imperial College School of Medicine
Paterson Centre
20 South Wharf Road
London
W2 1PD
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study acronymPOPMACT
Study objectivesTo 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
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedParasuicide
Intervention1. Manual assisted cognitive behaviour therapy (MACT)
2. Treatment as usual (TAU)
Intervention typeOther
Primary outcome measureRate of episodes of deliberate self-harm (using the Parasuicidal Acts Scale of Linehan) over the 12 month period
Secondary outcome measures1. 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
Overall study start date01/12/1997
Completion date01/10/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants500
Key inclusion criteriaPatients 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
Key exclusion criteria1. 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
Date of first enrolment01/12/1997
Date of final enrolment01/10/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Department of Psychiatry
London
W2 1PD
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

UK Medical Research Council

No information available

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?
Results article Results 01/02/2004 Yes No