Cited by 6Digital Mental Health InterventionsDiabetes Management and EducationMobile Health and mHealth Applications

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

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Boucher, Eliane, Moskowitz, Judith T, Kackloudis, Gina M, Stafford, Julia L, Kwok, Ian, Parks, Acacia C·2020·JMIR Research Protocols

Published version of a preprint

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

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Authors
Boucher, E., Moskowitz, J. T., Kackloudis, G. M., Stafford, J. L., Kwok, I., & Parks, A. C.
Affiliations
Northwestern University (US)
Corresponding author
Boucher, Eliane
Venue
JMIR Research Protocols
Published
2020-08-04
Volume
9
Issue
8
Pages
e18578
ISSN
1929-0748 (ISSN-L)
OpenAlex
W3022979516
Cited by
6
References
82
Citations by year
2025: 1 · 2024: 1 · 2023: 2 · 2022: 2
FWCI
0.90
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • JMIR Research Protocols (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
Keywords
digital mental health interventions, depression, positive emotion regulation, positive affect, HbA1c, glycemic control, medication adherence, diabetes self-care, diabetes distress, mood, long-term follow-up, smartphone-based intervention, psychoeducation, diabetes management, adults with diabetes

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