Cognitive behavioural therapy (CBT) for treatment resistant depression (TRD).
| ISRCTN | ISRCTN81845520 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81845520 |
| Protocol serial number | N0038133700 |
| Sponsor | Department of Health |
| Funder | Avon and Wiltshire Mental Health Partnership NHS Trust (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Prof Glyn Lewis
Scientific
Scientific
Academic Unit of Psychiatry
Bristol University
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
| Phone | +44 (0)117 954 6796 |
|---|---|
| Glyn.lewis@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Cognitive behavioural therapy (CBT) for treatment resistant depression (TRD). |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Depression |
| Intervention | 1. Usual care 2. Usual care and CBT |
| Intervention type | Other |
| Primary outcome measure(s) |
Beck Depression Inventory (BDI) score at 4 months post-randomisation. |
| Key secondary outcome measure(s) |
Quality of Life |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Total final enrolment | 316 |
| Key inclusion criteria | Primary care based patients who have not responded to antidepressant medication given at an adequate dose for 6 weeks or longer. |
| Key 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Unit of Psychiatry
Bristol
BS6 6JL
United Kingdom
BS6 6JL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
