Condition category
Mental and Behavioural Disorders
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
12/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor Peter Tyrer

ORCID ID

Contact details

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=15061347

Publication citations

  1. 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.

Additional files

Editorial Notes