Baseline Findings from ACT1VATE-A Novel RCT for Diabetes Distress

Recent interventions for diabetes distress (DD) have achieved dramatic improvements in DD, but not A1c. Further, none have been rigorously tested in the healthcare settings where individuals receive their diabetes care. An in-progress RCT will compare diabetes education (DSME/S) to an Acceptance and Commitment Therapy group program (ACT1VATE) in improving glycemic management in N = 484 adults with type 1 diabetes, A1c ≥ 8, and significant DD. We predict that ACT1VATE will be superior to DSME/S in improving DD and glycemic management given its 1) goal to change one's relationship with difficult diabetes thoughts/emotions driving problematic health behaviors and 2) linkage of diabetes self-care behavior to one's personal values, thus eliciting intrinsic motivation for meaningful, lasting health behavior changes. Thus far, enrolled participants (N = 105) are predominantly female (65%), non-Hispanic (83%), and employed (63.8%), but heterogeneous in terms of education (49.5% completed college, 26.1% high school or less), household income (24% < $50k, 38% > $100k), and age (20 to 83; M = 45.9±16.1 years). Mean baseline A1c = 9.2±1.4 and Diabetes Distress Scale total = 2.8±0.9 (indicating “moderate/severe” distress). The Acceptance and Action Diabetes Questionnaire (AADQ) measured psychological processes targeted in ACT1VATE (psychological inflexibility, experiential avoidance). Consistent with our theoretical framework, at baseline, greater diabetes acceptance/action (higher AADQ) was significantly correlated with lower A1c (r = -.30) and diabetes distress (r = -.63), fewer missed insulin doses (r = -.38), healthier diet (r = .29) and better overall well-being (r = .55), ps < .01. As the first large scale DD RCT integrated in a real-world setting, this study will build on prior well-controlled efficacy trials and provide rich information about implementation. These findings will inform healthcare systems’ attempts to meet ADA recommendations to integrate DD screenings and interventions into routine care. Disclosure E.C.Soriano: None. A.L.Fortmann: Employee; Dexcom, Inc. H.Sandoval: None. M.G.Antrim: None. S.Guzman: Consultant; Abbott Diabetes. W.H.Polonsky: Consultant; Abbott Diabetes, Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Insulet Corporation, Intuity Medical, Inc., MannKind Corporation, Provention Bio, Inc., Sanofi-Aventis U.S., Vertex Pharmaceuticals Incorporated. S.R.Spierling bagsic: None. A.Philis-tsimikas: Advisory Panel; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Other Relationship; Medtronic, Research Support; Novo Nordisk A/S, Lilly, Viking Therapeutics, NIH - National Institutes of Health. Funding National Institutes of Health (1R01DK127491)