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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/10077290
Publication citations
-
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.