Addressing diabetes distress in community health centers: protocol for the ARISE study, a pragmatic cluster randomized trial

Abstract Background Diabetes distress (DD), emotional burden of stress, fear, and guilt related to managing diabetes, is linked to poor glycemic control and disproportionately affects vulnerable populations. Although the American Diabetes Association and European Association for the Study of Diabetes recommend routine screening and intervention for DD, few health systems have implemented systematic screening and follow-up, and no studies have evaluated the impact of implementing DD screening and treatment workflows in real-world primary care. ARISE (Achieving Routine Intervention and Screening for Emotional health) is a training and technical assistance program designed to support multidisciplinary teams at community health centers (CHCs) in implementing DD screening and intervention for adults with type 2 diabetes (T2DM), based on the 7 A’s model (Aware, Ask, Assess, Advise, Assist, Assign, Arrange). Methods/Design This is a pragmatic, type 1 hybrid effectiveness-implementation cluster randomized trial in which 12 CHCs in the Midwest will be randomized 2:1 to ARISE (n=8) or Enhanced Usual Care (n=4). Eligible patients are aged ≥ 18 with T2DM and hemoglobin A1c (HbA1c) >8% who speak English or Spanish and are not pregnant. ARISE clinics will participate in webinars on assessing DD using the Type 2 Diabetes Distress Assessment System (T2-DDAS) and strategies to address DD via the 7A's model and motivational interviewing, followed by monthly virtual learning community sessions for interactive training, implementation planning, and problem-solving. Enhanced Usual Care clinics will receive a webinar on DD. Data will be collected via pre- and post-training staff surveys, meeting notes, post-screening checklists, and staff and patient interviews from ARISE clinics; all clinics will contribute patient-level EHR data. The primary outcome is change in HbA1c at 12 months. Secondary outcomes include change in DD within the ARISE group and between-group differences in LDL, systolic blood pressure, and BMI. Implementation outcomes will be evaluated using the RE-AIM framework. Discussion This trial is the first to evaluate a program facilitating DD assessment and intervention for T2DM in real-world primary care. ARISE provides an opportunity to assist CHCs, which serve a disproportionate burden of individuals with diabetes and DD, in improving guideline-based care for underserved populations while informing the scalability of DD-focused care in safety-net primary care nationally. Trial registration ClinicalTrials.gov NCT06887049, registered 03/13/2025.