EMBARK: A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress and Improving HbA_1c in Adults With Type 1 Diabetes

OBJECTIVE To compare the effectiveness of three interventions to reduce diabetes distress (DD) and improve HbA_1c among adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS Individuals with T1D (n = 276) with elevated DD (a score >2 on the total Type 1 Diabetes Distress Scale) and HbA_1c (>7.5%) were recruited from multiple settings and randomly assigned to one of three virtual group-based programs: 1) Streamline, an educator-led education and diabetes self-management program; 2) TunedIn, a psychologist-led program focused exclusively on emotional-focused DD reduction; or 3) FixIt, an integration of Streamline and TunedIn. Assessments of the primary outcomes of DD and HbA_1c occurred at baseline and at 3, 6, and 12 months. RESULTS All three programs demonstrated substantive and sustained reductions in DD (Cohen’s d = 0.58–1.14) and HbA_1c (range, 20.4 to 20.72) at 12-month follow-up. TunedIn and FixIt participants reported significantly greater DD reductions compared with Streamline participants (P = 0.007). Streamline and TunedIn participants achieved significantly greater HbA_1c reductions than did FixIt participants (P = 0.006). CONCLUSIONS DD can be successfully reduced among individuals with T1D with elevated HbA_1c using both the educational/behavioral and emotion-focused approaches included in the study. Although both approaches are associated with significant and clinically meaningful reductions in DD and HbA_1c, TunedIn, the emotion-focused program, had the most consistent benefits across both DD and HbA_1c. The study findings suggest the overall value of group-based, fully virtual, and time-limited emotion-focused strategies, like those used in TunedIn, for adults with T1D.