Achieving Routine Intervention and Screening for Emotional Health (ARISE)

June 3, 2026 updated by: University of Chicago

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient at a participating clinic
  • Type 2 diabetes
  • Adult (18 years or older)
  • A1C > 8%

Exclusion Criteria:

  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARISE Learning Community Arm
Community Health Centers will be given an in-depth training on the ARISE screening and intervention algorithm
Behavioral: ARISE Learning Community Diabetes Distress Screening and Intervention
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.
Other: ARISE Enhanced Care
Community Health Centers will be given a brief training on the 7A's model of diabetes distress screening and intervention
Behavioral: ARISE Enhanced Care brief training
Brief training on American Diabetes Association guidelines for screening for diabetes distress using the 7A's model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of A1C across time
Time Frame: 12 months
Rate of A1C from Baseline to follow-up
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average diabetes distress score
Time Frame: 12 months
Rate of diabetes distress at each community health center based on average of patients' "core" and "sources" screening scores (based on T2-DDAS screening)
12 months
Average of low density lipoproteins (LDL Cholesterol) measure
Time Frame: 12 months
Rate of average measure of patients' cholesterol in the blood
12 months
Average systolic blood pressure across time
Time Frame: 12 months
Average of patients' systolic blood pressure (measures the arterial pressure)
12 months
Average Body mass index at baseline and follow-up
Time Frame: 12 months
Average of patients' BMI (a measure of height and weight)
12 months
Average depression screening (PHQ)
Time Frame: 12 months
Average of patients' degree of depression based on survey
12 months
Average score of anxiety screening (GAD)
Time Frame: 12 months
Average of patients' degree of anxiety based on survey
12 months
Average number of referrals across patients over time
Time Frame: 12 months
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.)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Francisco
Midwest Clinicians' Network

Investigators

  • Principal Investigator: Arshiya Baig, MD, MPH, University of Chicago
  • Principal Investigator: Danielle Hessler Jones, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-0622
  • R01DK133603-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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