Type 2 Diabetes Mellitus (T2DM)ARISENCT06887049
Achieving Routine Intervention and Screening for Emotional Health
A study testing ARISE Learning Community Diabetes Distress Screening and Intervention and ARISE Enhanced Care brief training in people with Type 2 Diabetes Mellitus (T2DM) and Diabetes Distress, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Diabetes Distress
- What is being tested?
- ARISE Learning Community Diabetes Distress Screening and Intervention and ARISE Enhanced Care brief training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at a participating clinic
- Type 2 diabetes
- Adult (18 years or older)
- A1C > 8%
- English- or Spanish-speaking
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Sr. Research Project Manager, 773-834-5646, abigail.durgan@bsd.uchicago.edu
About this study
Official title: ARISE: Achieving Routine Intervention and Screening for Emotional Health: Randomized Controlled Trial
The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).
Read the detailed description
Diabetes mellitus (DM) affects 30 million people in the U.S.1 The prevalence of diabetes is higher among Hispanics (12.5%) and African Americans (11.7%) compared to non-Hispanic whites (7.5%). Managing type 2 DM (T2DM) can be complex and burdensome; patients must modify their diet and exercise habits, take medications, check their blood sugars, visits their healthcare providers regularly, and navigate work and family life. Financial insecurity and social risks (e.g., transportation access) also disproportionately affect persons of color in the U.S. and in turn impede patients' ability to adhere to diabetes self-care recommendations. Diabetes distress (DD) is the stress, fear, and guilt in having to manage diabetes and is distinct from depression and anxiety. A meta-analysis of 58 international studies noted one in five adults with diabetes had elevated DD.6 DD has well documented associations with poor medication adherence, dietary and exercise behaviors, quality of life, and glycosylated hemoglobin (A1C). African-Americans and Hispanics have higher levels of DD compared to non-Hispanic whites.
The American Diabetes Association published guidelines promoting screening for and addressing DD as a critical part of clinical care. Multiple studies have tested standardized screening instruments for DD and intervention studies have demonstrated reductions in DD. However, only 24% of adults with diabetes report their health care team asked them how diabetes affected their lives and far fewer currently receive structured DD screening and follow-up. Efforts to systematically identify and address DD could be an important strategy to improve diabetes outcomes and address diabetes disparities. Community health centers (CHCs) can be important partners in this effort. CHCs provide primary care for 2.5 million adults with diabetes, of whom 30% have A1C >9% and 57% are racial ethnic minorities.
No studies have systematically implemented DD screening and treatment interventions into a real-world primary care setting or used a guideline based approach. To fill this gap, we developed the ARISE (Achieving Routine Intervention and Screening for Emotional health) intervention. ARISE is a primary care training and implementation program for clinicians and allied health professionals to support screening for and address DD in T2DM. ARISE utilizes a standardized process for screening adult patients with T2DM for DD using validated instruments, provides training and support for CHC staff applying evidence-based strategies on how to address DD in the encounter, and an algorithm for action steps and referrals based on individualized sources of DD (e.g. hypoglycemia, access based on social needs). This pragmatic study will compare ARISE to enhanced usual care (didactic lecture for clinical staff on emotional health of persons with diabetes) using a type I hybrid effectiveness-implementation design via a cluster randomized controlled trial. This study provides the opportunity to optimize T2DM care for populations with health disparities concordant with evidence-based guidelines to aid in the attainment of optimal glycemic control.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Diabetes Distress
- Being tested
- ARISE Learning Community Diabetes Distress Screening and Intervention, ARISE Enhanced Care brief training
- Keywords
- diabetes distress screening
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARISE Learning Community Diabetes Distress Screening and InterventionBehavioural
In-depth training for frontline community health center staff on ARISE algorithm to screen for degree of diabetes distress using T2-DDAS Core. If positive, screen for sources of diabetes distress using T2-DDAS Sources. Discuss results with patient and make any relevant referrals.
ARISE Enhanced Care brief trainingBehavioural
Brief training on American Diabetes Association guidelines for screening for diabetes distress using the 7A's model
| Study group | Role | What they receive |
|---|---|---|
| ARISE Learning Community Arm | Experimental | Community Health Centers will be given an in-depth training on the ARISE screening and intervention algorithm Receives: Behavioral: ARISE Learning Community Diabetes Distress Screening and Intervention |
| ARISE Enhanced Care | Other | Community Health Centers will be given a brief training on the 7A's model of diabetes distress screening and intervention Receives: Behavioral: ARISE Enhanced Care brief training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of A1C across time
Rate of A1C from Baseline to follow-up
Measured: 12 months
Secondary outcomes (7)
Average diabetes distress score
Rate of diabetes distress at each community health center based on average of patients' "core" and "sources" screening scores (based on T2-DDAS screening)
Measured: 12 months
Average of low density lipoproteins (LDL Cholesterol) measure
Rate of average measure of patients' cholesterol in the blood
Measured: 12 months
Average systolic blood pressure across time
Average of patients' systolic blood pressure (measures the arterial pressure)
Measured: 12 months
Average Body mass index at baseline and follow-up
Average of patients' BMI (a measure of height and weight)
Measured: 12 months
Average depression screening (PHQ)
Average of patients' degree of depression based on survey
Measured: 12 months
Average score of anxiety screening (GAD)
Average of patients' degree of anxiety based on survey
Measured: 12 months
Average number of referrals across patients over time
Average of patients' number of referrals to other providers or resources, and frequencies of different types of referrals made (e.g., rate of patients sent to OBGYN, Ophthalmology, etc.)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start10 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Midwest Clinicians' Network
- Responsible party
- Sponsor
- Investigators
- Arshiya Baig, MD, MPH, Principal investigator, University of ChicagoDanielle Hessler Jones, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887049
- Sponsor's protocol ID
- IRB24-0622
- Other IDs
- R01DK133603-02
- Acronym
- ARISE
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisher L, Polonsky WH, Hessler D. Addressing diabetes distress in clinical care: a practical guide. Diabet Med. 2019 Jul;36(7):803-812. doi: 10.1111/dme.13967. Epub 2019 May 7.
PubMed 30985025Chew BH, Vos RC, Metzendorf MI, Scholten RJ, Rutten GE. Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2017 Sep 27;9(9):CD011469. doi: 10.1002/14651858.CD011469.pub2.
PubMed 28954185Shin, P., Sharac, J., Barber, Z., Rosenbaum, S., & Paradise, J. (2015, March). Community Health Centers: A 2013 Profile and Prospects as ACA Implementation Proceeds. The Henry J. Kaiser Family Foundation. Retrieved from http://kff.org/medicaid/issue-brief/community-health-centers-a-2013-profileand-prospects-as-aca-implementation-proceeds/
Health Resources and Services Administration (HRSA). Health Center Program. Table 7. Health Outcomes and Disparities. National Data. Available at: https://data.hrsa.gov/tools/datareporting/program-data/national/table?tableName=7&year=2020.
Schmidt CB, van Loon BJP, Vergouwen ACM, Snoek FJ, Honig A. Systematic review and meta-analysis of psychological interventions in people with diabetes and elevated diabetes-distress. Diabet Med. 2018 Jun 13. doi: 10.1111/dme.13709. Online ahead of print.
PubMed 29896760Wagner H, Pizzimenti JJ, Daniel K, Pandya N, Hardigan PC. Eye on diabetes: a multidisciplinary patient education intervention. Diabetes Educ. 2008 Jan-Feb;34(1):84-9. doi: 10.1177/0145721707312205.
PubMed 18267994Nicolucci A, Kovacs Burns K, Holt RI, Comaschi M, Hermanns N, Ishii H, Kokoszka A, Pouwer F, Skovlund SE, Stuckey H, Tarkun I, Vallis M, Wens J, Peyrot M; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs second study (DAWN2): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes. Diabet Med. 2013 Jul;30(7):767-77. doi: 10.1111/dme.12245.
PubMed 23711019Fisher L, Hessler D, Glasgow RE, Arean PA, Masharani U, Naranjo D, Strycker LA. REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care. 2013 Sep;36(9):2551-8. doi: 10.2337/dc12-2493. Epub 2013 Jun 4.
PubMed 23735726Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
PubMed 15735199Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997 May;20(5):760-6. doi: 10.2337/diacare.20.5.760.
PubMed 9135939LeBron AM, Valerio MA, Kieffer E, Sinco B, Rosland AM, Hawkins J, Espitia N, Palmisano G, Spencer M. Everyday discrimination, diabetes-related distress, and depressive symptoms among African Americans and Latinos with diabetes. J Immigr Minor Health. 2014 Dec;16(6):1208-16. doi: 10.1007/s10903-013-9843-3.
PubMed 23689972Sturt J, Dennick K, Hessler D, Hunter BM, Oliver J, Fisher L. Effective interventions for reducing diabetes distress: systematic review and meta-analysis. International Diabetes Nursing. 2015;12(2):40-55.
Skinner TC, Joensen L, Parkin T. Twenty-five years of diabetes distress research. Diabet Med. 2020 Mar;37(3):393-400. doi: 10.1111/dme.14157. Epub 2019 Oct 31.
PubMed 31638279Dennick K, Sturt J, Speight J. What is diabetes distress and how can we measure it? A narrative review and conceptual model. J Diabetes Complications. 2017 May;31(5):898-911. doi: 10.1016/j.jdiacomp.2016.12.018. Epub 2017 Feb 14.
PubMed 28274681Snoek FJ, Bremmer MA, Hermanns N. Constructs of depression and distress in diabetes: time for an appraisal. Lancet Diabetes Endocrinol. 2015 Jun;3(6):450-460. doi: 10.1016/S2213-8587(15)00135-7. Epub 2015 May 17.
PubMed 25995123