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NCT Number: NCT06887049

Achieving Routine Intervention and Screening for Emotional Health

The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Sr. Research Project Manager

CONTACT

[email protected]

773-834-5646

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant

Treatment and study plan

ARISE Learning Community Diabetes Distress Screening and Intervention

Behavioral

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 training

Behavioral

Brief training on American Diabetes Association guidelines for screening for diabetes distress using the 7A's model

Primary outcomes

  1. Rate of A1C across time

    Time frame: 12 months

    Rate of A1C from Baseline to follow-up

Secondary outcomes

  1. 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)

  2. Average of low density lipoproteins (LDL Cholesterol) measure

    Time frame: 12 months

    Rate of average measure of patients' cholesterol in the blood

  3. Average systolic blood pressure across time

    Time frame: 12 months

    Average of patients' systolic blood pressure (measures the arterial pressure)

  4. Average Body mass index at baseline and follow-up

    Time frame: 12 months

    Average of patients' BMI (a measure of height and weight)

  5. Average depression screening (PHQ)

    Time frame: 12 months

    Average of patients' degree of depression based on survey

  6. Average score of anxiety screening (GAD)

    Time frame: 12 months

    Average of patients' degree of anxiety based on survey

  7. 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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Abby Sr. Research Project Manager, MSW

CONTACT

[email protected]

773-834-5646

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ARISE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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