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. 2017 Aug 3;6(8):e145.
doi: 10.2196/resprot.7348.

A Web-Based Public Health Intervention to Reduce Functional Impairment and Depressive Symptoms in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial Protocol

Judy Proudfoot #  1   2 , Janine Clarke #  1 , Jane Gunn #  3 , Susan Fletcher #  3 , Samineh Sanatkar  1 , Kay Wilhelm  2 , Lesley Campbell  4 , Nicholas Zwar  5 , Mark Harris  6 , Helen Lapsley  2 , Dusan Hadzi-Pavlovic  2 , Helen Christensen  1   2
Affiliations

A Web-Based Public Health Intervention to Reduce Functional Impairment and Depressive Symptoms in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial Protocol

Judy Proudfoot et al. JMIR Res Protoc. .

Abstract

Background: Depressive symptoms are common in people with type 2 diabetes and contribute to adverse health consequences that substantially impact social and vocational function. Despite the existence of effective depression treatments, the majority of people with type 2 diabetes do not access these when needed. Web-based alternatives to more traditional psychotherapies offer a potential solution to reducing the personal and economic burdens of type 2 diabetes.

Objective: This paper outlines the protocol for a randomized controlled trial (RCT) of myCompass, a Web-based public health psychotherapy intervention, in people with type 2 diabetes. Fully automated, interactive, and delivered via the Internet without clinician support, myCompass teaches cognitive behavioral therapy-based skills and supports symptom monitoring to improve daily functioning and reduce mild-to-moderate mental health symptoms.

Methods: A two-arm RCT will be conducted. People with type 2 diabetes and mild-to-moderately severe depressive symptoms will be recruited from the community and general practice settings. Screening and enrollment is via an open-access website. Participants will be randomized to use either myCompass or an active placebo program for 8 weeks, followed by a 4-week tailing-off period. The placebo program is matched to myCompass on mode of delivery, interactivity, and duration. Outcomes will be assessed at baseline and at 3-month, 6-month, and 12-month follow-up. The primary study outcome is work and social functioning. Secondary study outcomes include depressive and anxious symptoms, diabetes-related distress, self-care behaviors, and glycemic control.

Results: Nationwide recruitment is currently underway with the aim of recruiting 600 people with type 2 diabetes. Recruitment will continue until October 2017.

Conclusions: This is the first known trial of a Web-based psychotherapy program that is not diabetes specific for improving social and vocational function in people with type 2 diabetes and mild-to-moderately severe depressive symptoms. With the increasing prevalence of type 2 diabetes and depression, a potentially scalable public health intervention could play a very large role in reducing unmet mental health need and ameliorating the personal and societal impact of illness comorbidity.

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) Number: ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109 (Archived by WebCite at http://www.webcitation.org/ 6rh3imVMh).

Keywords: Web-based intervention; depression; type 2 diabetes.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Screenshot of myCompass landing page.
Figure 2
Figure 2
Screenshot of myCompass self-monitoring page.
Figure 3
Figure 3
Screenshot of a page from the myCompass module Tackling Unhelpful Thinking.
Figure 4
Figure 4
Screenshot of myCompass graphical feedback.
Figure 5
Figure 5
Screenshot of landing page for placebo program, Healthy Lifestyles.
Figure 6
Figure 6
Page from the Healthy Lifestyles module, The Skin You Live In.
Figure 7
Figure 7
Sample interactive task from the Healthy Lifestyles module.
Figure 8
Figure 8
SpringboarD participant flow diagram.
See this image and copyright information in PMC

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