Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
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

Prof Peter Tyrer

ORCID ID

Contact details

St Mary's Hospital Medical School
Patterson Centre
20 South Wharf Road
London
W2 1PD
United Kingdom
+44 (0)20 7886 1648
p.tyrer@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC00388

Study information

Scientific title

Acronym

Study hypothesis

A pilot study will test the efficacy of a new psychological treatment for patients seen after an episode of deliberate self-harm (parasuicide or attempted suicide). The treatment is based on a self-treatment manual (suicide behaviour prevention manual) developed by us from previous work by Linehan and Davidson on the cognitive treatment of patients with borderline and anti-social personality disorder. Although the previous treatment has been shown to be successful in reducing episodes of deliberate self-harm it is very intensive and not suitable for general use. Our treatment comprises one session of explanation of the manual followed by a maximum of five further sessions of treatment using a psychoeducational and problem solving approach to suicide behaviour.

60 patients aged between 16 and 40 living in Paddington, Marylebone, Chelsea and Kensington will be seen after an episode of deliberate self-harm who have at least one previous suicide attempt in the past year and qualify for personality disturbance (either difficulty or disorder) in one of the flamboyant categories (histrionic, borderline, impulsive, anti-social). They will be randomised to treatment as usual or to the experimental group and treated for up to three months. Assessment of health service costs, suicide intent and acts, mood disturbance and social functioning will be made before randomisation and after six months by an independent research psychologist.

If the treatment is found to be successful an application will be made to the MRC for a larger study in a population with less restrictive entrance criteria.

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mental and behavioural disorders: Other mental disorder

Intervention

1. Psychological treatment using a psychoeducational and problem solving approach to suicide behaviour: manual-assisted cognitive-behaviour therapy (MACT)
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main outcome measures will be the time of the next parasuicide act (using Linehan's definition of this, which is more minor than an actual suicide attempt). Our expectation is that our experimental treatment will extend this from a mean of three weeks to a mean of three months and this will require a sample size of 30 in each treatment group.

Secondary outcome measures

1. Time to first suicidal act
2. Rate of suicidal acts
3. Change in anxiety and depressive symptoms

Overall trial start date

01/01/1996

Overall trial end date

31/12/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Efficacy of a new brief manualised form of cognitive behaviour therapy in those with personality disturbance within the flamboyant (cluster B) group. Thirty four patients were enrolled and 32 (18 MACT; 14 TAU) were seen at follow-up.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/01/1996

Recruitment end date

31/12/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital Medical School
London
W2 1PD
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (UK)

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 in http://www.ncbi.nlm.nih.gov/pubmed/10077290

Publication citations

  1. Results

    Evans K, Tyrer P, Catalan J, Schmidt U, Davidson K, Dent J, Tata P, Thornton S, Barber J, Thompson S, Manual-assisted cognitive-behaviour therapy (MACT): a randomized controlled trial of a brief intervention with bibliotherapy in the treatment of recurrent deliberate self-harm., Psychol Med, 1999, 29, 1, 19-25.

Additional files

Editorial Notes