SpringboarD: Trial of a self-help intervention to improve functioning and emotional well-being in people with type 2 diabetes

Problem

Diabetes and depression are complex, chronic and disabling medical conditions that are highly comorbid and together, are a potentially deadly combination. Only one-third of people with diabetes and depression receive appropriate treatment for both disorders. A population-based approach to early intervention for depression and in people with T2D is urgently needed. This study is testing whether an online, cognitive behavioural therapy based self-help program (myCompass) can address this need.

Approach

600 participants will be randomised to use myCompass (active intervention) or a credible Internet-delivered placebo control program containing factual health information about a range of topics (but with no therapeutic content). Both programs will be available to participants for 8 weeks, followed by a 4-week tailing off period.

Recruitment will be via information distributed by general practices in two states in Australia (NSW and Victoria), and through the community. Project information will invite potential candidates to visit a study-specific website to provide consent and participate in eligibility screening. Eligibility criteria include: aged 18-75 years, diagnosed type 2 diabetes, and current depressive symptoms; valid email address; access to internet; internet-enabled mobile phone. Exclusion criteria include: currently receiving face-to-face therapy for depression; extremely severe depression; high suicide risk; current symptoms of psychosis; change in anti-depressant medication in the previous 2 months; and previous use of myCompass.

Eligible candidates will complete an online baseline questionnaire and be allocated randomly to use the intervention or control program. Follow-up questionnaires will be completed online at the conclusion of the intervention phase (i.e., 3 months) and again at 6, 12 and 24 months. Haemoglobin A1c (HbA1c) data will be provided by participants’ GP at baseline, 6, 12, and 24 months.

Findings

The project’s primary objective is to test the hypothesis that work and social functioning will be significantly improved in people with T2D and depressive symptoms following use of a fully-automated self-help e-mental health intervention, compared with those in a placebo control group. Secondary outcomes include depressive symptoms, diabetes-related distress, suicidal ideation, positive well-being, diabetes self-management and glycemic control (HbA1c).

Outcomes will be evaluated by intention-to-treat (ITT) analyses using mixed models repeated measures (MMRM). Supplementary analyses will use data for completers and will also investigate possible differences by recruitment source, duration of diabetes and presence of comorbid conditions. Adjustments will be made for multiple statistical testing, as appropriate.

Consequences

The myCompass program is a scalable intervention that may be readily incorporated into routine primary care for people with T2D and depression. It has the potential to make a substantial contribution to health and quality of life outcomes for people with T2D, and lead to cost savings across a range of related health areas, including microvascular and cardiovascular disease.