Immediate and Long-Term Effects of an 8-Week Digital Mental Health Intervention on Adults With Poorly Managed Type 2 Diabetes: Protocol for a Randomized Controlled Trial (Preprint)

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 May 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 Winter 2020, with completion of the 12-month follow-up in Winter 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 effects 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. CLINICALTRIAL ClinicalTrials.gov: NCT04068805.

Appropriate controls for digital therapeutic clinical trials: A narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content

“…In addition, beyond typical placebo effects, there is currently a lack of understanding of efficacy related to the digital mode of delivery, such as the intervention structure, engagement support, or regular, focused time spent in the app (31). Most DTx recommend regular, often daily use (27,32,33), and deliver engaging experiences (e.g. gamification (27,34) or social support (33)) to support adherence.…”

“…Different approaches were used to design sham content: Sham controls either replaced core treatment activities with "fake, but plausible therapies" (33) or they delivered general, disease agnostic wellbeing tips (32,56). Another strategy was to "disarm" certain content, which means removing key aspects hypothesized to drive efficacy.…”

“…Another strategy was to "disarm" certain content, which means removing key aspects hypothesized to drive efficacy. For example, psychoeducational content included in the DTx may be retained in the sham control, but related quizzes or concrete skill training based on the educational content were specific to the therapeutic (32). Finally, certain content and/or features were removed in the control condition, mainly disease specific therapeutic content (e.g.…”

“…Finally, certain content and/or features were removed in the control condition, mainly disease specific therapeutic content (e.g. CBT (32,56)) or additional disease management features (community features (33)).…”