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

Thomas, L.J. et al. (2012) Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: the CoBalT randomised controlled trial protocol. Contemporary Clinical Trials, 33(2), pp. 312-319. (doi:10.1016/j.cct.2011.10.016)

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Abstract

<b>Background</b> 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.<p></p> <b>Methods/design</b> 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-II); (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-II 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.<p></p> <b>Discussion</b> The CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy. Given the move to widen access to ‘talking therapies’, the results of this study will be timely.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Williams, Professor Christopher and Ridgway, Dr Nicola and Morrison, Professor Jillian
Authors: Thomas, L.J., Abel, A., Ridgway, N., Peters, T., Kessler, D., Hollinghurst, S., Turner, K., Garland, A., Jerrom, B., Morrison, J., Williams, C., Campbell, J., Kuyken, W., Lewis, G., and Wiles, N.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > General Practice and Primary Care
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Mental Health and Wellbeing
Journal Name:Contemporary Clinical Trials
ISSN:1551-7144

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
459001Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care - a randomised controlled trial (COBALT)Christopher WilliamsHealth Technology Assessment (HTA)06/404/02IHW - MENTAL HEALTH & WELLBEING