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

Abstract

Background Diabetes is a leading cause of years of life lost and accounts for approximately one-fourth of health care dollars spent in the United States. 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, predicts poorer management of one’s diabetes, whereas positive affect predicts engaging in more positive health behaviors. Consequently, interventions that improve depression and positive affect may also improve diabetes-related outcomes among people with diabetes. 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 This study aims to examine 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 hemoglobin A1c (HbA1c) levels (≧7), and moderate to severe depressive symptoms will be randomly assigned to a positive emotion regulation 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 postintervention. Throughout the intervention and for 1 week at each postintervention follow-up, participants will complete daily assessments of diabetes-related distress, diabetes regimen adherence, and mood. Our primary outcome, HbA1c, will be self-reported every 3 months throughout the study. Secondary and exploratory outcomes will be assessed at baseline; at 8 weeks; and at 3, 6, and 12 months postintervention. Results Recruitment is expected to begin in June 2020. Participants will begin the study as they are recruited and will finish in waves. The final wave of data collection from the 8-week intervention is expected for winter 2020, with the completion of the 12-month follow-up in winter 2021. Conclusions Although previous research suggests that 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. Trial Registration ClinicalTrials.gov NCT04068805; https://clinicaltrials.gov/ct2/show/NCT04068805. International Registered Report Identifier (IRRID) PRR1-10.2196/18578

The Nexus Between Diabetes and Depression: A Narrative Review

“…. Most recently, in the medical field, healthcare professionals are focusing on non-face-toface models of alternative psychological interventions, including ICTs, known as eHealth, digital mental health intervention, and computer-based diabetes self-management interventions[98][99][100]. A systematic review of ICT-based psychological interventions appeared to reduce depressive symptomatology without improving glycemic control effectively[98].…”

“…These new interventions are rapidly advancing; the scientific evidence is recent and very limited. More studies and economic analyses are needed to compare these interventions with the traditional face-to-face model and integrate these treatments into clinical practice[98][99][100].…”

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

“…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.…”

“…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.…”