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

ISRCTN	ISRCTN88887622
DOI	https://doi.org/10.1186/ISRCTN88887622
Secondary identifying numbers	REC00168

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Philip Richardson
Scientific

The Tavistock Clinic
120 Belsize Lane
London
NW3 5BA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and behavioural disorders: Other mental disorder
Intervention	1. 24 sessions of cognitive-analytical therapy (CAT) 2. Standard care
Intervention type	Other
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 study start date	01/07/1998
Completion date	01/07/1999

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	48
Key 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).
Key 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)
Date of first enrolment	01/07/1998
Date of final enrolment	01/07/1999

The Tavistock Clinic

London
NW3 5BA
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive London

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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