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ISRCTN
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ISRCTN70300925
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ClinicalTrials.gov identifier
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Public title
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Effectiveness of counselling, cognitive behavioural therapy and GP care for depression in general practice
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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 93/07/66
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Study hypothesis
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The aim of this study was to determine both the clinical and cost-effectiveness of usual general practitioner (GP) care compared with two types of brief psychological therapy (non-directive counselling and cognitive¿behaviour therapy) in the management of depression as well as mixed anxiety and depression in the primary care setting.
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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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1. GP diagnosis of depression / mixed depression and anxiety
2. 18+ years of age
3. 14+ on Beck Depression Inventory (BDI)
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Participants - exclusion criteria
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1. Serious suicidal intent
2. Treated with medication or psychological therapy in past 6 months
3. Unable to complete questionnaires due to language difficulties, illiteracy or learning difficulty.
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Anticipated start date
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01/10/1995
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Anticipated end date
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31/01/1999
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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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197
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Interventions
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The design was principally a pragmatic randomised controlled trial, but was accompanied by two additional allocation methods allowing patient preference: the option of a specific choice of treatment (preference allocation) and the option to be randomised between the psychological therapies only. Of the 464 patients allocated to the three treatments, 197 were randomised between the three treatments, 137 chose a specific treatment, and 130 were randomised between the psychological therapies only. The patients underwent follow-up assessments at 4 and 12 months.
The interventions consisted of brief psychological therapy (12 sessions maximum) or usual GP care.
i. Non-directive counselling was provided by counsellors who were qualified for accreditation by the British Association for Counselling.
ii. Cognitive behaviour therapy was provided by clinical psychologists who were qualified for accreditation by the British Association for Behavioural and Cognitive Psychotherapies.
iii. Usual GP care included discussions with patients and the prescription of medication, but GPs were asked to refrain from referring patients for psychological intervention for at least 4 months.
Most therapy sessions took place on a weekly basis in the general practices. By the 12-month follow-up, GP care in some cases did include referral to mental healthcare specialists.
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Primary outcome measure(s)
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The clinical outcomes included depressive symptoms, general psychiatric symptoms, social function and patient satisfaction. The economic outcomes included direct and indirect costs and quality of life. Assessments were carried out at baseline during face-to-face interviews as well as at 4 and 12 months in person or by post.
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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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2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11099284
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Contact name
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Prof
Michael
King
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Address
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Department of Psychiatry and Behavioural Sciences
Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
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City/town
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London
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Zip/Postcode
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NW3 2PF
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Country
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United Kingdom
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Tel
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+44 (0)20 7830 2397
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Fax
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+44 (0)20 7 830 2808
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Email
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m.king@rfc.ucl.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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27/08/2009
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Date ISRCTN assigned
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25/04/2003
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