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
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
-
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.