Contact information
Type
Scientific
Primary contact
Prof Michael King
ORCID ID
Contact details
Department of Psychiatry and Behavioural Sciences
Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7830 2397
m.king@rfc.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/07/66
Study information
Scientific title
Acronym
Study hypothesis
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.
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
Not Specified
Patient information sheet
Condition
Mental and behavioural disorders: Depression, anxiety, neuroses
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/10/1995
Overall trial end date
31/01/1999
Reason abandoned
Eligibility
Participant inclusion criteria
1. GP diagnosis of depression / mixed depression and anxiety
2. 18+ years of age
3. 14+ on Beck Depression Inventory (BDI)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
197
Participant exclusion criteria
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.
Recruitment start date
01/10/1995
Recruitment end date
31/01/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychiatry and Behavioural Sciences
London
NW3 2PF
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
2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11099284
Publication citations
-
Results
Ward E, King M, Lloyd M, Bower P, Sibbald B, Farrelly S, Gabbay M, Tarrier N, Addington-Hall J, Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. I: clinical effectiveness., BMJ, 2000, 321, 7273, 1383-1388.