title: Web-based cognitive behavioural therapy (W-CBT) for diabetes patients with co-morbid depression: design of a randomised controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN24874457.
authors.affiliation: Department of Medical Psychology, VU University Medical Centre, The Netherlands. k.vanbastelaar@vumc.nl.
authors.forename: Kim M P
authors.initials: KM
authors.lastname: van Bastelaar
authors.forename: Frans
authors.initials: F
authors.lastname: Pouwer
authors.forename: Pim
authors.initials: P
authors.lastname: Cuijpers
authors.forename: Jos W R
authors.initials: JW
authors.lastname: Twisk
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Snoek
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D015897:Comorbidity; D003866:Depressive Disorder / Q000523:psychology / Q000628:therapy*; D003922:Diabetes Mellitus, Type 1 / Q000523:psychology*; D003924:Diabetes Mellitus, Type 2 / Q000523:psychology*; D030141:Feedback, Psychological; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020407:Internet; D008297:Male; D010349:Patient Compliance / Q000706:statistics & numerical data; D010353:Patient Education as Topic; D010555:Personality Inventory; D012648:Self Care; D012985:Software Design; D016896:Treatment Outcome