A randomised controlled trial to evaluate the efficacy and cost-effectiveness of counselling in patients with chronic depression and anxiety
ISRCTN | ISRCTN93023252 |
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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
Scientific
Dept of Psychology
Southwood Side
University of Greenwich
Avery Hill Road
Eltham
London
SE9 2UG
United Kingdom
Phone | +44 (0)20 8331 9160 |
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R.H.CORNEY@greenwich.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | A randomised controlled trial to evaluate the efficacy and cost-effectiveness of counselling in patients with chronic depression and anxiety |
Study objectives | 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(s) | Not provided at time of registration. |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 15/08/1995 |
Completion date | 14/07/1999 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 70 Years |
Sex | Both |
Target number of participants | 181 |
Total final enrolment | 181 |
Key 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. |
Key exclusion criteria | Not provided at time of registration. |
Date of first enrolment | 15/08/1995 |
Date of final enrolment | 14/07/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept of Psychology
London
SE9 2UG
United Kingdom
SE9 2UG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Phone | +44 (0)1132 545 843 |
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Sheila.Greener@doh.gsi.gov.uk | |
Website | http://www.dh.gov.uk/en/index.htm |
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 | |
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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 |
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.