Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/02/2014
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 Philip Richardson

ORCID ID

Contact details

The Tavistock Clinic
120 Belsize Lane
London
NW3 5BA
United Kingdom
+44 (0)20 74473834

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC00168

Study information

Scientific title

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes