Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9702283
Study information
Scientific title
Acronym
POPMACT
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Parasuicide
Intervention
1. Manual assisted cognitive behaviour therapy (MACT)
2. Treatment as usual (TAU)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Rate of episodes of deliberate self-harm (using the Parasuicidal Acts Scale of Linehan) over the 12 month period
Secondary outcome measures
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
Overall trial start date
01/12/1997
Overall trial end date
01/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
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
Recruitment start date
01/12/1997
Recruitment end date
01/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Department of Psychiatry
London
W2 1PD
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
UK Medical Research Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Publication citations
-
Results
Tyrer P, Tom B, Byford S, Schmidt U, Jones V, Davidson K, Knapp M, MacLeod A, Catalan J, , Differential effects of manual assisted cognitive behavior therapy in the treatment of recurrent deliberate self-harm and personality disturbance: the POPMACT study., J. Pers. Disord., 2004, 18, 1, 102-116.