A randomised controlled trial to evaluate the efficacy and cost-effectiveness of counselling in patients with chronic depression and anxiety

ISRCTN	ISRCTN93023252
DOI	https://doi.org/10.1186/ISRCTN93023252
Secondary identifying numbers	HTA 93/07/68

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 11/07/2019

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 Roslyn Corney
Scientific

Dept of Psychology
Southwood Side
University of Greenwich
Avery Hill Road
Eltham
London
SE9 2UG
United Kingdom

Phone	+44 (0)20 8331 9160
Email	R.H.CORNEY@greenwich.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	Treatment
Scientific title	A randomised controlled trial to evaluate the efficacy and cost-effectiveness of counselling in patients with chronic depression and anxiety
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/08/1995
Completion date	14/07/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Both
Target number of participants	181
Total final enrolment	181
Key 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.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	15/08/1995
Date of final enrolment	14/07/1999

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Dept of Psychology

London
SE9 2UG
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 in:HTA monograph)	01/09/2000		Yes	No

Editorial Notes

11/07/2019: Total final enrolment added.