Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06887049

ARISE: Achieving Routine Intervention and Screening for Emotional Health Randomized Controlled Trial

Led by University of Chicago · Updated on 2026-06-05

1250

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

U

University of California, San Francisco

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on adults with type 2 diabetes mellitus (T2DM) to evaluate how screening for diabetes distress and related interventions affect patients. Diabetes distress, which is the stress and worry related to managing diabetes, is common and linked to poorer self-care and health outcomes. The study aims to improve diabetes care for diverse populations, especially in community health centers that care for many racial and ethnic minorities. Participants will be involved in one of two study groups. One group will receive detailed training on the ARISE program, a structured approach to screen for diabetes distress and address it using personalized strategies and referrals. The other group will receive a brief training on a general diabetes distress screening model. The study compares these approaches through a cluster randomized controlled trial involving community health centers. Throughout the 12 months of the study, researchers will monitor blood sugar control (A1C levels), diabetes distress scores, cholesterol, blood pressure, body mass index, depression and anxiety screenings, and the number of referrals made. The study includes regular assessments and tracks changes over time to understand the impact of these screening and intervention strategies on patient health and emotional well-being.

CONDITIONS

Brief Title

Achieving Routine Intervention and Screening for Emotional Health

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient at a participating clinic
  • Diagnosed with type 2 diabetes
  • Adult aged 18 years or older
  • A1C greater than 8%
Not Eligible

You will not qualify if you...

  • Currently pregnant

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 months

Participants receive training and support in diabetes distress screening and intervention through their community health centers.

Visits as part of routine healthcare at community health centers

Long-term Monitoring

Duration - 12 months

Participants are monitored for diabetes-related health outcomes including A1C levels, diabetes distress, cholesterol, blood pressure, and mental health over time.

Assessments conducted at baseline and follow-up visits during the 12 months

Trial Site Locations

Total: 1 location

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

A

Abby Sr. Research Project Manager, MSW

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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Published Research Related To This Trial

Systematic review and meta-analysis of psychological interventions in people with diabetes and elevated diabetes-distress.

C B Schmidt, B J Potter van Loon, A C M Vergouwen...

https://pubmed.ncbi.nlm.nih.gov/29896760

Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes.

A Nicolucci, K Kovacs Burns, R I G Holt...

https://pubmed.ncbi.nlm.nih.gov/23711019

Everyday discrimination, diabetes-related distress, and depressive symptoms among African Americans and Latinos with diabetes.

Alana M W LeBron, Melissa A Valerio, Edith Kieffer...

https://pubmed.ncbi.nlm.nih.gov/23689972