Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
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 Michael King

ORCID ID

Contact details

Department of Psychiatry and Behavioural Sciences
Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7830 2397
m.king@rfc.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/07/66

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study was to determine both the clinical and cost-effectiveness of usual general practitioner (GP) care compared with two types of brief psychological therapy (non-directive counselling and cognitive¬Ņbehaviour therapy) in the management of depression as well as mixed anxiety and depression in the primary care setting.

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: Depression, anxiety, neuroses

Intervention

The design was principally a pragmatic randomised controlled trial, but was accompanied by two additional allocation methods allowing patient preference: the option of a specific choice of treatment (preference allocation) and the option to be randomised between the psychological therapies only. Of the 464 patients allocated to the three treatments, 197 were randomised between the three treatments, 137 chose a specific treatment, and 130 were randomised between the psychological therapies only. The patients underwent follow-up assessments at 4 and 12 months.
The interventions consisted of brief psychological therapy (12 sessions maximum) or usual GP care.
i. Non-directive counselling was provided by counsellors who were qualified for accreditation by the British Association for Counselling.
ii. Cognitive behaviour therapy was provided by clinical psychologists who were qualified for accreditation by the British Association for Behavioural and Cognitive Psychotherapies.
iii. Usual GP care included discussions with patients and the prescription of medication, but GPs were asked to refrain from referring patients for psychological intervention for at least 4 months.
Most therapy sessions took place on a weekly basis in the general practices. By the 12-month follow-up, GP care in some cases did include referral to mental healthcare specialists.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The clinical outcomes included depressive symptoms, general psychiatric symptoms, social function and patient satisfaction. The economic outcomes included direct and indirect costs and quality of life. Assessments were carried out at baseline during face-to-face interviews as well as at 4 and 12 months in person or by post.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/10/1995

Overall trial end date

31/01/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. GP diagnosis of depression / mixed depression and anxiety
2. 18+ years of age
3. 14+ on Beck Depression Inventory (BDI)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

197

Participant exclusion criteria

1. Serious suicidal intent
2. Treated with medication or psychological therapy in past 6 months
3. Unable to complete questionnaires due to language difficulties, illiteracy or learning difficulty.

Recruitment start date

01/10/1995

Recruitment end date

31/01/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychiatry and Behavioural Sciences
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11099284

Publication citations

  1. Results

    Ward E, King M, Lloyd M, Bower P, Sibbald B, Farrelly S, Gabbay M, Tarrier N, Addington-Hall J, Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. I: clinical effectiveness., BMJ, 2000, 321, 7273, 1383-1388.

Additional files

Editorial Notes