Effectiveness of counselling, cognitive behavioural therapy and GP care for depression in general practice

ISRCTN	ISRCTN70300925
DOI	https://doi.org/10.1186/ISRCTN70300925
Secondary identifying numbers	HTA 93/07/66

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 27/08/2009

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 Michael King
Scientific

Department of Psychiatry and Behavioural Sciences
Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom

Phone	+44 (0)20 7830 2397
Email	m.king@rfc.ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/1995
Completion date	31/01/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	197
Key inclusion criteria	1. GP diagnosis of depression / mixed depression and anxiety 2. 18+ years of age 3. 14+ on Beck Depression Inventory (BDI)
Key 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.
Date of first enrolment	01/10/1995
Date of final enrolment	31/01/1999

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Psychiatry and Behavioural Sciences

London
NW3 2PF
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	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
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	02/12/2000		Yes	No