Cognitive behavioural therapy (CBT) for treatment resistant depression (TRD).

ISRCTN	ISRCTN81845520
DOI	https://doi.org/10.1186/ISRCTN81845520
Secondary identifying numbers	N0038133700

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 10/11/2022

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

Not provided at time of registration

Contact information

Prof Glyn Lewis
Scientific

Academic Unit of Psychiatry
Bristol University
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom

Phone	+44 (0)117 954 6796
Email	Glyn.lewis@bristol.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	Cognitive behavioural therapy (CBT) for treatment resistant depression (TRD).
Study hypothesis	How effective is CBT in the treatment of resistant (refractory) depression? About 30% of depressed patients do not respond to a course of antidepressants at the recommended dosage after 6 weeks and are sometimes described as having treatment refractory or treatment resistant depression (TRD). At present, clinical guidelines do not provide specific advice about how to manage this situation. No RCTs have investigated a psychological treatment for this patient group (Stimpson et al, 2002). However, there are indications that psychological treatments may be effective. For example, cognitive behavioural therapy (CBT) is known to be effective in those with residual depressive symptoms (Paykel et al, 1999). CBT is the most widely available structured psychotherapy for depression in specialist mental health services in the NHS. Most research into CBT has examined the effectiveness of CBT for previously untreated depressive episodes. However, CBT is usually used for those who have not responded to pharmacotherapy in primary care i.e. those who are treatment resistant. This study is a pilot study for a pragmatic randomised controlled trial of the clinical effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy in treatment resistant depression. The objectives of the pilot study are to investigate the feasibility of the proposed trial. In particular, the pilot aims to (i) estimate the rate of recruitment and (ii) investigate the quality of the CBT.
Ethics approval(s)	Not provided at time of registration
Condition	Mental and Behavioural Disorders: Depression
Intervention	1. Usual care 2. Usual care and CBT
Intervention type	Other
Primary outcome measure	Beck Depression Inventory (BDI) score at 4 months post-randomisation.
Secondary outcome measures	Quality of Life
Overall study start date	01/01/2004
Overall study end date	31/07/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	40
Total final enrolment	316
Participant inclusion criteria	Primary care based patients who have not responded to antidepressant medication given at an adequate dose for 6 weeks or longer.
Participant exclusion criteria	Added July 2008: 1. Patients with bipolar disorder, psychosis, personality disorder or major alcohol or substance abuse problems 2. Patients who had been continually depressed for more than 5 years 3. Patients those unable to complete the study questionnaires 4. Patients who had previously or were currently receiving CBT therapy 5. Patients currently receiving other psychotherapy or secondary care for their depression
Recruitment start date	01/01/2004
Recruitment end date	31/07/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Unit of Psychiatry

Bristol
BS6 6JL
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Avon and Wiltshire Mental Health Partnership NHS Trust (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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/08/2007		Yes	No

Editorial Notes

10/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.