Researchers have launched a trial designed to answer a question that has long gone untested in routine care: what happens when community health centers systematically screen for diabetes distress and then act on the results? The ARISE study, short for Achieving Routine Intervention and Screening for Emotional health, is described in a newly published protocol in BMC Primary Care as a pragmatic, type 1 hybrid effectiveness-implementation cluster randomized trial. Its registered aim is to evaluate whether a training and technical assistance program can help multidisciplinary teams at community health centers implement screening and intervention for diabetes distress among adults with type 2 diabetes.
Diabetes distress is defined in the protocol as the emotional burden of stress, fear, and guilt related to managing diabetes. The condition is linked to poor glycemic control and disproportionately affects vulnerable populations. Professional bodies have taken notice: the American Diabetes Association and the European Association for the Study of Diabetes recommend routine screening and intervention for diabetes distress. Yet according to the study team, few health systems have implemented systematic screening and follow-up, and no studies have evaluated the impact of implementing diabetes distress screening and treatment workflows in real-world primary care. That gap is precisely what ARISE is designed to address.
The trial’s structure reflects its pragmatic ambitions. Twelve community health centers in the Midwest will be randomized in a 2:1 ratio, with eight clinics assigned to the ARISE program and four to an Enhanced Usual Care comparator. Eligible patients are adults aged 18 or older with type 2 diabetes and a hemoglobin A1c above 8%, who speak English or Spanish and are not pregnant. The focus on safety-net settings is deliberate. Community health centers serve a disproportionate burden of individuals with diabetes and diabetes distress, the protocol notes, making them a critical testing ground for guideline-based emotional health care for underserved populations.
ARISE is built around the 7 A’s model: Aware, Ask, Assess, Advise, Assist, Assign, Arrange. Clinics assigned to the intervention will first take part in webinars covering how to assess diabetes distress using the Type 2 Diabetes Distress Assessment System, or T2-DDAS, and strategies to address distress through the 7 A’s model combined with motivational interviewing. Those webinars will be followed by monthly virtual learning community sessions offering interactive training, implementation planning, and problem-solving. The comparison arm is intentionally lighter: Enhanced Usual Care clinics will receive a single webinar on diabetes distress.
Data collection is planned across multiple channels. In ARISE clinics, the study will gather pre- and post-training staff surveys, meeting notes, post-screening checklists, and staff and patient interviews. All clinics in the trial, including the comparison sites, will contribute patient-level electronic health record data. This mix of qualitative and quantitative sources is intended to capture not only whether the workflows change clinical outcomes but also how the implementation unfolds on the ground in busy primary care settings.
The primary outcome is the change in hemoglobin A1c at 12 months. Secondary outcomes include the change in diabetes distress within the ARISE group, and between-group differences in LDL cholesterol, systolic blood pressure, and BMI. The hybrid effectiveness-implementation design means the trial is positioned to generate evidence on both clinical results and the practicalities of embedding distress screening into everyday workflows.
The study team, led by D. Hessler Jones with colleagues including A. M. Durgan, E. M. Staab, and senior author A. A. Baig, among others, emphasizes that ARISE is the first trial to evaluate a program facilitating diabetes distress assessment and intervention for type 2 diabetes in real-world primary care. The trial is registered at ClinicalTrials.gov under identifier NCT06887049, registered on March 13, 2025, and the protocol article was published on October 22, 2026 as an open-access study protocol.
It is important to be clear about what the publication does and does not contain. This is a protocol, not a results paper. No findings on glycemic control, distress reduction, or implementation success are yet available, and the trial’s registration and peer-reviewed protocol do not establish that the intervention works. Any conclusions about whether ARISE improves HbA1c or reduces diabetes distress must await the trial’s completion and analysis. What the protocol does establish is the study’s planned methods, its populations, its outcomes, and the framework by which its results will eventually be judged.
Even so, the protocol’s publication marks a meaningful step for a field in which guidance has outpaced practice. If the trial demonstrates that structured screening and intervention workflows can function in resource-constrained safety-net clinics, the findings could inform how diabetes distress care is scaled nationally. The study team frames the work as an opportunity to assist community health centers in improving guideline-based care for underserved populations while informing the scalability of diabetes distress-focused care in safety-net primary care across the country. For now, patients and clinicians alike will be watching for the trial’s results, which remain in the future.
Subject of Research: A study protocol for a pragmatic cluster randomized trial of diabetes distress screening and intervention workflows in community health centers
Article Title: Addressing diabetes distress in community health centers: protocol for the ARISE study, a pragmatic cluster randomized trial
Article References: Hessler Jones, D., Durgan, A. M., Staab, E. M., Campbell, A., Schaefer, C., Wan, W., Wing, H., Zhu, H., Kasir, C., Mendoza, M. A., & Baig, A. A. (2026). Addressing diabetes distress in community health centers: protocol for the ARISE study, a pragmatic cluster randomized trial. BMC Primary Care. https://doi.org/10.1186/s12875-026-03613-x
Image Credits: AI Generated
DOI: 10.1186/s12875-026-03613-x
Keywords: diabetes distress, type 2 diabetes, community health centers, cluster randomized trial, HbA1c, implementation science, primary care, 7 A's model, health equity, study protocol, RE-AIM, safety-net care
News Source: Phoebe Ingram. (October 29, 2026). ARISE trial to test diabetes distress screening and care workflows in community health centers. Scienmag.
