protocol for a randomised clinical trial of a web-based psychoeducational treatment for bipolar disorder

Smith, D., Simpson, S. , Forty, L., Barnes, E., Jones, I., Griths, E., Hood, K. and Craddock, N. (2009) protocol for a randomised clinical trial of a web-based psychoeducational treatment for bipolar disorder. Bipolar Disorders. Supplement, 11(Sup 1), p. 81. (doi: 10.1111/j.1399-5618.2009.00695.x)

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Introduction: Psychoeducational interventions have emerged as effective long-term therapeutic options for bipolar disorder. The best evidence exists for group psychoeducation, although this may be expensive and logistically difficult to deliver to large numbers of patients. We have developed a novel, web-based interactive psychoeducational intervention for bipolar disorder, called ‘‘Beating Bipolar’’ ( Here we report the trial protocol for the evaluation of ‘‘Beating Bipolar’’ (Trial registration: ISRCTN81375447). This intervention was developed using an iterative process involving focus groups with patients, their carers, families and health professionals. The purpose of these groups was to advise on the design and content of the programme, as well as to revise and refine the intervention. The primary focus of the intervention is the recognition and self-management of chronic depressive symptoms, depressive relapse and associated functional impairments, although manic features are also covered. The intervention involves a blending of different delivery mechanisms, with initial face-to-face delivery, followed by written and webbased interactive delivery of factual content and ongoing support via a web forum. The web-based content requires the reader to be engaged in a number of interactive exercises in order to maximise long-term retention of the material. The key areas covered in the package are: i) the accurate diagnosis of bipolar disorder; ii) the causes of bipolar disorder; iii) the role of medication; iv) the role of lifestyle changes; v) relapse prevention and early intervention; vi) psychological approaches; vii) genderspecific considerations and viii) advice for family and carers. The 8 modules will be delivered online on a fortnightly basis over a four-month period. There will be an initial face-to-face introductory meeting with participants designed to engage them with the programme. Thereafter, participants will log onto the website and complete a module. Each module is then discussed within an online forum for participants, which will be moderated by a psychiatrist (DJS). This forum will facilitate peer support and will allow us to provide clarification of module content, answer questions from participants and provide on-going support and engagement.<p></p> Methods and Results: This study is an exploratory, individually randomised controlled trial. The control intervention will be treatment-as-usual. We will recruit 100 patients, currently in clinical remission, with a diagnosis of DSM-IV bipolar disorder (including type I and type II) verified according to the Mini International Neuropsychiatric Interview (MINI). Outcomes will be assessed at the end of the delivery of the intervention and 6 months later. The primary outcome measure will be quality of life, measured using the WHOQOL-Bref. Secondary outcome assessments will include scores on: the Global Assessment of Functioning (GAF); the Functioning Assessment Short Test (FAST); the Schedule of Assessment of Insight (SAI); the Montgomery Asberg Depression Rating Scale (MADRS); the Young Mania Rating Scale (YMRS); and the number and severity of depressive and manic or hypomanic episodes experienced during the follow-up period. An assessment of costs and a detailed process evaluation involving qualitative interviews with participants will also be completed.<p></p> Discussion: Bipolar disorder is common, under-recognised and often poorly managed, particularly with regard to chronic depressive features. This trial will evaluate the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder. The findings from this exploratory trial will inform the design of a definitive randomised controlled trial.<p></p>

Item Type:Articles
Glasgow Author(s) Enlighten ID:Simpson, Professor Sharon
Authors: Smith, D., Simpson, S., Forty, L., Barnes, E., Jones, I., Griths, E., Hood, K., and Craddock, N.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
Journal Name:Bipolar Disorders. Supplement
Publisher:Wiley-Blackwell Publishing, Inc.
ISSN (Online):1399-5618

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