Completed Psychology & Behaviour Mental Health

Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: a randomised controlled trial

Funder NIHR (part of DHSC)
Recipient organisation University of Bristol
Funding £1.5M
Period May 2008 — Feb 2013

In plain English

AI plain-English summary

Around one in three people with depression do not get better after trying a single antidepressant, yet their GPs have few evidence-based options beyond switching or adding another drug. This trial tests whether adding a course of cognitive behavioural therapy (CBT) to usual medication and clinical management can help those patients. The problem is that treatment-resistant depression is common in primary care, but most research on CBT for depression has excluded these patients. GPs lack clear data on whether talking therapy works when antidepressants alone have failed. This trial directly compares usual care with usual care plus CBT, measuring depressive symptoms, quality of life, and antidepressant use at six and twelve months. If CBT proves effective, the NHS could offer a structured, non-drug option for patients stuck in a cycle of medication changes. That would give GPs a practical, scalable tool for a group that currently has few proven alternatives. Even if the results are negative, the trial will provide much-needed evidence to guide clinical decisions and avoid ineffective treatments.

View original technical description
Patients with treatment resistant depression in primary care (defined as those who have significant depressive symptoms following at least 6 weeks treatment with antidepressant medication at an adequate dose) will be invited to participate in this randomised controlled trial. Those who give written informed consent will be randomised to (1) usual care i.e. pharmacological treatment and clinical management, or (2) CBT in addition to usual care. All patients will be taking antidepressant medication at the time of randomisation. Those randomised to CBT will receive a course of 12 sessions, with (up to) a further 6 sessions, if deemed clinically appropriate by the therapist. Each session will last 50 minutes. Outcome will be measured at 6 months and 12 months post-randomisation with the Beck Depression Inventory (BDI). The primary outcome is the BDI score at 6-months post-randomisation, specifically a binary variable representing response, defined as a reduction in depressive symptoms of at least 50% compared to baseline. Secondary outcomes will include remission of symptoms, quality of life and use of antidepressants, together with outcomes measured at 12-months post-randomisation

Related Research

Grants with similar aims, by meaning.

Intensive psychotherapy for chronic, treatment-resistant depression: a pilot investigation of clinical effectiveness and mediators of learning in the Cognitive Behavioural Analysis System of Psychotherapy (CBASP)
A double blind placebo-controlled randomised trial of the addition of the antidepressant mirtazapine for patients with depression in primary care who have not responded to at least 6 weeks of antidepressant treatment
The Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) Trial
A randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies
Anticipate: A randomised trial of cognitive therapy for antenatal depression

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