A randomised controlled trial to evaluate the efficacy and cost-effectiveness of counselling in patients with chronic depression and anxiety

ISRCTN ISRCTN93023252
DOI https://doi.org/10.1186/ISRCTN93023252
Secondary identifying numbers HTA 93/07/68
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
11/07/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Roslyn Corney
Scientific

Dept of Psychology
Southwood Side
University of Greenwich
Avery Hill Road
Eltham
London
SE9 2UG
United Kingdom

Phone +44 (0)20 8331 9160
Email R.H.CORNEY@greenwich.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA randomised controlled trial to evaluate the efficacy and cost-effectiveness of counselling in patients with chronic depression and anxiety
Study objectivesTo 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedMental and behavioural disorders: Depression, anxiety, neuroses
InterventionA 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 typeOther
Primary outcome measureThe 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 measuresNot provided at time of registration.
Overall study start date15/08/1995
Completion date14/07/1999

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants181
Total final enrolment181
Key inclusion criteriaPatients 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.
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment15/08/1995
Date of final enrolment14/07/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Dept of Psychology
London
SE9 2UG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results in:HTA monograph) 01/09/2000 Yes No

Editorial Notes

11/07/2019: Total final enrolment added.