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

Laura J. Thomas, Anna Abel, Nicola Ridgway, Tim Peters, David Kessler, Sandra Hollinghurst, Katrina Turner, Anne Garland, Bill Jerrom, Jill Morrison, Chris Williams, John Campbell, Willem Kuyken, Glyn Lewis, Nicola Wiles

Research output: Contribution to journalArticle (Academic Journal)peer-review

24 Citations (Scopus)


Background: Antidepressants are often the first-line treatment for depression but only one third of patients respond fully to pharmacotherapy. This paper describes the protocol for a randomised controlled trial (RCT) designed to evaluate the clinical and cost effectiveness of cognitive behavioural therapy (CBT) as an adjunct to pharmacotherapy for patients with treatment resistant depression in primary care.

Methods/design: CoBalT is a two parallel group multi-centre pragmatic RCT. Eligible participants were those who: (i) were aged 18-75 years; (ii) were currently taking antidepressant medication (for at least 6 weeks at an adequate dose); (iii) scored >= 14 on the Beck Depression Inventory (BDI-11); (iv) had adhered to their medication; and (v) met ICD-10 criteria for depression (assessed using the Clinical Interview Schedule revised version). Those who gave written informed consent were randomised to one of two treatment groups: usual care or usual care plus CBT. The primary outcome is depressive symptoms assessed using the BDI-11 at 6 months post-randomisation. Secondary outcomes measured at 6 and 12 months include quality of life, antidepressant use and health care utilisation. Outcomes will be analysed on an intention-to-treat basis.

Original languageEnglish
Pages (from-to)312-319
Number of pages8
JournalContemporary Clinical Trials
Issue number2
Publication statusPublished - Mar 2012

Cite this