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Open Access Highly Accessed Study protocol

Web-based cognitive behavioural therapy (W-CBT) for diabetes patients with co-morbid depression: Design of a randomised controlled trial

Kim MP van Bastelaar125*, Frans Pouwer12, Pim Cuijpers23, Jos WR Twisk24 and Frank J Snoek12

Author Affiliations

1 Department of Medical Psychology, VU University Medical Centre, The Netherlands

2 EMGO Institute, VU University Medical Centre, The Netherlands

3 Department of Clinical Psychology, VU University Medical Centre, The Netherlands

4 Department of Clinical Epidemiology and Biostatistics, VU University Medical Centre, The Netherlands

5 VU University Medical Centre, Department of Medical Psychology, Diabetes Psychology Research Group, Van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands

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BMC Psychiatry 2008, 8:9  doi:10.1186/1471-244X-8-9

Published: 19 February 2008

Abstract

Background

Depression is common among people with diabetes, negatively affecting quality of life, treatment adherence and diabetes outcomes. In routine clinical care, diabetes patients have limited access to mental health services and depression therefore often remains untreated. Web-based therapy could potentially be an effective way to improve the reach of psychological care for diabetes patients, at relatively low costs. This study seeks to test the effectiveness of a web-based self-help depression programme for people with diabetes and co-morbid depression.

Methods/Design

The effectiveness of a web-based self-help course for adults with diabetes with co-morbid depression will be tested in a randomised trial, using a wait-list controlled design. The intervention consists of an 8-week, moderated self-help course that is tailored to the needs of persons living with diabetes and is offered on an individual basis. Participants receive feedback on their homework assignments by e-mail from their coach. We aim to include 286 patients (143/143), as power analyses showed that this number is needed to detect an effect size of 0.35, with measurements at baseline, directly after completing the web-based intervention and at 1, 3, 4 and 6 months follow-up. Patients in the control condition are placed on a waiting list, and follow the course 12 weeks after randomisation.

Primary outcomes are depressive symptoms and diabetes-specific emotional distress. Secondary outcomes are satisfaction with the course, perceived health status, self-care behaviours, glycaemic control, and days in bed/absence from work. Questionnaires are administered via the Internet.

Discussion

The intervention being trialled is expected to help improve mood and reduce diabetes-specific emotional distress in diabetes patients with depression, with subsequent beneficial effects on diabetes self-care and glycaemic outcomes. When proven efficacious, the intervention could be disseminated to reach large groups of patients with diabetes and concurrent depressive symptoms.

Trial registration

Current Controlled Trials ISRCTN24874457