JMIR Publications

ABSTRACT

Background:

Diabetes is a leading cause of years of life lost and accounts for approximately one quarter of healthcare dollars spent in the United States. However, many of these costs are related to poor medication adherence and lack of self-care behaviors, and are thus preventable. Depression, which is more prevalent among people with diabetes than in the general population, contributes to poorer management of one’s diabetes, whereas positive affect predicts a higher frequency of positive health behaviors. Consequently, interventions that improve depression and positive affect may also improve diabetes-related outcomes among people with a diabetes diagnosis. Although preliminary research on the impact of such interventions among people with diabetes is promising, these studies focused primarily on in-person interventions, have had small samples, and lack long-term follow-up.

Objective:

The aim of the current study is to test the short- and long-term effects of a digital therapeutic platform focused on mental health among adults with poorly managed Type 2 diabetes and elevated levels of depression.

Methods:

This is a randomized controlled trial in which adults with a Type 2 diabetes diagnosis, elevated HBA1C (>7), and moderate to severe depressive symptoms will be randomly assigned to a Diabetes Positive Affect Skills Intervention group or a sham digital intervention with only psychoeducational content. The study will take place over 14 months, including the 8-week intervention (or control) delivered via a digital therapeutic platform (Happify Health) and follow-up assessments at 3-, 6-, and 12-months post-intervention. Throughout the 8-week intervention and for one week at each post-intervention follow-up, participants will complete daily assessments of diabetes-related distress, positive affect skills use, diabetes regimen adherence, and mood. Our primary outcome, HBA1C, will be self-reported every three months throughout the study. Secondary and exploratory outcomes will be assessed at baseline, 8 weeks, and 3-, 6-, and 12-months post-intervention.

Results:

Recruitment is expected to begin in March 2020. Participants will begin the study as they are recruited and thus will finish in waves. The final wave of data collection from the eight-week intervention is expected for Fall 2020, with completion of the 12-month follow-up in Fall 2021.

Conclusions:

While previous research suggests in-person psychological interventions have promising effects on both psychological and physical outcomes among adults with diabetes, digital interventions can be advantageous because they are easily scalable and reduce many barriers that prevent people from seeking treatment. This trial will provide important information about the of a digital mental health intervention among adults with Type 2 diabetes, assessing both short- and long-term effects of this intervention on HbA1c, depressive symptoms, and other diabetes-specific outcomes. If successful, this may introduce a scalable intervention that would help reduce some of the preventable costs associated with diabetes. Clinical Trial: ClinicalTrials.gov: NCT04068805.