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

Abstract

BackgroundDepressive 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.ObjectiveThis 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.MethodsA 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.ResultsNationwide recruitment is currently underway with the aim of recruiting 600 people with type 2 diabetes. Recruitment will continue until October 2017.ConclusionsThis 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 RegistrationAustralian 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)

The influence of personality on trajectories of distress, health and functioning in mild-to-moderately depressed adults with type 2 diabetes

“…This study was an adjunct to the SpringboarD Trial; a large community-based randomised controlled trial (RCT) of an online public health intervention called myCompass to increase functioning and mental health in adults with T2DM. The full trial protocol is detailed elsewhere (Proudfoot et al, 2017 participants was required to detect the medium effects observed in similar studies (Strickhouser, Zell, & Krizan, 2017). Therefore, between April and July 2018, we emailed invitations to the first 297 SpringboarD participants to complete the 12-month self-report assessment.…”

A Web-Based Cognitive Behavior Therapy Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial

“…This study is the primary outcomes evaluation of a 2-arm RCT called SpringboarD . The full protocol for the SpringboarD Trial is published elsewhere [27]. In the full SpringboarD trial, outcomes will be assessed at baseline and 3, 6, and 12 months postrandomization.…”

“…The program offers a personalized treatment plan based on an assessment of user symptoms, either at registration or at any time during program use [25,27]. The core program consists of 12 interactive CBT modules and 20 cognitive and/or behavioral variables for self-monitoring.…”

Web-Based Interventions for Depression in Individuals with Diabetes: Review and Discussion (Preprint)

“…Andersson and his colleagues [60] recommend to make it very clear to the client that there is a person behind the support, to present the staff behind the intervention, including names and pictures.…”

“…A review on web-based treatments for depression and anxiety disorders showed positive correlation between the amount of contact spent by therapist per patient (range from none to 333 min) and the effect size (d range from 0 to 1.5) [63]. Andersson and cols [60] suggest from their experience in depression web-based interventions to spend by therapist an average of 100 min per patient for a 10-week intervention. There is still the need to study how much therapist time spend per patient is more cost-effective.…”