Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00168
Study information
Scientific title
A randomised controlled trial (RCT) to assess the incremental costs and clinical benefits of cognitive analytic therapy (CAT) to standard care within community mental health teams in the treatment of severe personality disorder
Acronym
Study hypothesis
Cognitive-analytic therapy (CAT) has established a claim to make a valuable and economic contribution to the treatment of patients with severe personality disorders. This has been demonstrated in a range of descriptive and clinical case studies though no randomised controlled study has so far established its effectiveness with this severely disturbed patient group.
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
Not Specified
Patient information sheet
Condition
Mental and behavioural disorders: Other mental disorder
Intervention
1. 24 sessions of cognitive-analytical therapy (CAT)
2. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Beck Depression Inventory, Structured Clinical Interview for DSM-IV, MCMI-III, Client Service Receipt Interview.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/1998
Overall trial end date
01/07/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
48 'hard to treat' mental health service users with complex mental health problems who have been in active contact with the participating trusts for at least one year and whose major presenting problems have not been successfully treated. Inclusion criteria:
1. A diagnosis of Cluster B Personality Disorder (Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM IV], Axis II - as per Million Clinical Multiaxial Inventory III [MCMI III])
2. A Beck Depression Index score above 25
3. One year (or longer) history of unsuccessful treatment (assessed by case note review by the responsible medical officers [RMOs]); or at least two hospital admissions in the past 5 years following parasuicide.
4. Still on active caseload of Community Mental Health Team (CMHT) (Care Programme Approach [CPA] level 1 or higher).
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
48
Participant exclusion criteria
1. Concurrent organic or definite psychotic illness (though patients suffering micropsychotic episodes only will not be excluded)
2. Referral to CAT services in past five years
3. Currently receiving another formal psychological treatment
4. Current admission to inpatient care (though subsequent admission during the course of the trial will not exclude patients from further follow-up)
5. Current active substance abuse (including alcohol)
Recruitment start date
01/07/1998
Recruitment end date
01/07/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Tavistock Clinic
London
NW3 5BA
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
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