Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
26/08/2009
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 Roslyn Corney

ORCID ID

Contact details

Dept of Psychology
Southwood Side
University of Greenwich
Avery Hill Road
Eltham
London
SE9 2UG
United Kingdom
+44 (0)20 8331 9160
R.H.CORNEY@greenwich.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/07/68

Study information

Scientific title

Acronym

Study hypothesis

To examine the effectiveness and cost-effectiveness of short-term counselling in general practice for patients with chronic depression or combined depression and anxiety, compared with general practitioner (GP) care alone.

Please note that the target number of participants was added as of 26/08/2009.

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: Depression, anxiety, neuroses

Intervention

A randomised controlled trial and economic evaluation with an initial assessment at randomisation and follow-ups at 6 and 12 month. The study used 9 general practices that were well-established participants of the Derbyshire counselling in general practice scheme, and already had a counsellor in the practice team.
The experimental group received usual GP treatment and were also referred to an experienced well-qualified counsellor attached to their general practice. Of the 8 counsellors, 2 practiced cognitive behavioural therapy (CBT) and 6 had a psychodynamic approach. The controls were referred back to their GP for routine treatment. There were no restrictions regarding the treatment that could be used, except that GPs could not refer controls to practice counsellors.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The main outcome measure was the BDI. Others included the Brief Symptom Inventory, the Inventory of Interpersonal Problems and the Social Adjustment Scale. All tests were given at initial, 6- and 12-month assessments. Comprehensive costs were also estimated, and combined with changes in outcomes to examine between-group differences and whether counselling was more cost-effective than standard GP care.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

15/08/1995

Overall trial end date

14/07/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Patients were screened at GP practices and asked to participate if they scored 14 on the Beck Depression Inventory (BDI), had suffered depression or depression/anxiety for 6 months or more, were aged 18-70 and had no history of drug or alcohol abuse, psychosis or suicidal tendencies.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

181

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

15/08/1995

Recruitment end date

14/07/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Psychology
London
SE9 2UG
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

HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/11134918

Publication citations

  1. HTA monograph

    Simpson S, Corney R, Fitzgerald P, Beecham J, A randomised controlled trial to evaluate the effectiveness and cost-effectiveness of counselling patients with chronic depression., Health Technol Assess, 2000, 4, 36, 1-83.

Additional files

Editorial Notes