Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Glyn Lewis

ORCID ID

Contact details

Academic Unit of Psychiatry
Bristol University
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
+44 (0)117 954 6796
Glyn.lewis@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0038133700

Study information

Scientific title

Acronym

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

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

Intervention

1. Usual care
2. Usual care and CBT

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Beck Depression Inventory (BDI) score at 4 months post-randomisation.

Secondary outcome measures

Quality of Life

Overall trial start date

01/01/2004

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

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

United Kingdom

Trial participating centre

Academic Unit of Psychiatry
Bristol
BS6 6JL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Avon and Wiltshire Mental Health Partnership NHS Trust (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

A Randomized Controlled Trial of Cognitive Behavioural Therapy as an Adjunct to Pharmacotherapy in Primary Care Based Patients with Treatment Resistant Depression: A Pilot Study - Behavioural and Cognitive Psychotherapy, 2008, 36, 21-33 First published online 21 August 2007 doi:10.1017/S135246580700389X

Publication citations

Additional files

Editorial Notes