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ISRCTN
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ISRCTN93023252
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial to evaluate the efficacy and cost-effectiveness of counselling in patients with chronic depression and anxiety
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 93/07/68
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and behavioural disorders: Depression, anxiety, neuroses
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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15/08/1995
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Anticipated end date
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14/07/1999
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration.
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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1. HTA monograph on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11134918
2. Comment on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12622302
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Contact name
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Prof
Roslyn
Corney
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Address
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Dept of Psychology
Southwood Side
University of Greenwich
Avery Hill Road
Eltham
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City/town
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London
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Zip/Postcode
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SE9 2UG
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Country
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United Kingdom
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Tel
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+44 (0)20 8331 9160
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Fax
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+44 (0)20 8 331 8905
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Email
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R.H.CORNEY@greenwich.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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25/01/2008
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Date ISRCTN assigned
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25/04/2003
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