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 (â§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.
ABSTRACT
BACKGROUND: Chronic conditions account for 75% of health care costs, and the impact of chronic illness is expected to grow over time. Although subjective well-being predicts better health outcomes, people with chronic conditions tend to report lower well-being. Improving well-being might mitigate costs associated with chronic illness; however, existing interventions can be difficult to access and draw from a single theoretical approach. Happify, a digital well-being intervention program drawing from multiple theoretical traditions to target well-being, has already been established as an efficacious means of improving well-being in both distressed and nondistressed users. OBJECTIVE: This study aimed to compare change in well-being over time after using Happify for users with and without a chronic condition. METHODS: Data were obtained from Happify users, a publicly available digital well-being program accessible via website or mobile phone app. Users work on tracks addressing a specific issue (eg, conquering negative thoughts) composed of games and activities based on positive psychology, cognitive behavioral therapy, and mindfulness principles. The sample included 821 users receiving at least 6 weeks' exposure to Happify (ranging from 42 to 179 days) who met other inclusion criteria. As part of a baseline questionnaire, respondents reported demographic information (age and gender) and whether they had any of the prespecified chronic conditions: arthritis, diabetes, insomnia, multiple sclerosis, chronic pain, psoriasis, eczema, or some other condition (450 reported a chronic condition, whereas 371 did not). Subjective well-being was assessed with the Happify Scale, a 9-item measure of positive emotionality and life satisfaction. To evaluate changes in well-being over time, a mixed effects linear regression model was fit for subjective well-being, controlling for demographics and platform usage. RESULTS: At baseline, users with a chronic condition had significantly lower subjective well-being (mean 38.34, SD 17.40) than users without a chronic condition (mean 43.65, SD 19.13). However, change trajectories for users with or without a chronic condition were not significantly different; both groups experienced equivalent improvements in well-being. We also found an effect for time from baseline (b=0.071; SE=0.010; P<.01) and number of activities completed (b=0.03; SE=0.009; P<.01), and a 2-way interaction between number of activities completed and time from baseline (b=0.0002; SE=0.00006; P<.01), such that completing more activities and doing so over increasingly longer periods produced improved well-being scores. CONCLUSIONS: Data from this study support the conclusion that users with a chronic condition experienced significant improvement over time. Despite reporting lower subjective well-being on the whole, their change trajectory while using Happify was equivalent to those without a chronic condition. Consistent with past research, users who completed more activities over a longer period showed the most improvement. In short, the presence of a chronic condition did not prevent users from showing improved well-being when using Happify.
