Achieving Routine Intervention and Screening for Emotional Health

NCT06887049 | Recruiting DMC

• 2 other identifiers: IRB24-0622R01DK133603-02
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes Distress; Type 2 Diabetes Mellitus (T2DM)

Keywords

diabetes distress screening

Outcome Measures

Primary Outcomes (1)

• Rate of A1C across time

  Rate of A1C from Baseline to follow-up

  12 months

Secondary Outcomes (7)

• Average diabetes distress score

  12 months

• Average of low density lipoproteins (LDL Cholesterol) measure

  12 months

• Average systolic blood pressure across time

  12 months

• Average Body mass index at baseline and follow-up

  12 months

• Average depression screening (PHQ)

  12 months

Study Arms (2)

ARISE Learning Community Arm

EXPERIMENTAL

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

ARISE Enhanced Care

OTHER

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

Interventions

ARISE Enhanced Care brief training BEHAVIORAL

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

ARISE Enhanced Care

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 Learning Community Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant

Sponsors & Collaborators

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

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (22)

• 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.

  PMID: 30985025 BACKGROUND

• Chew 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.

  PMID: 28954185 BACKGROUND

• Shin, 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/

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29896760 BACKGROUND

• Wagner 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.

  PMID: 18267994 BACKGROUND

• Nicolucci 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.

  PMID: 23711019 BACKGROUND

• Fisher 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.

  PMID: 23735726 BACKGROUND

• Polonsky 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.

  PMID: 15735199 BACKGROUND

• Welch 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.

  PMID: 9135939 BACKGROUND

• LeBron 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.

  PMID: 23689972 BACKGROUND

• Sturt 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.

  BACKGROUND

• 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.

  PMID: 31638279 BACKGROUND

• Dennick 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.

  PMID: 28274681 BACKGROUND

• Snoek 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.

  PMID: 25995123 BACKGROUND

• Indelicato L, Dauriz M, Santi L, Bonora F, Negri C, Cacciatori V, Targher G, Trento M, Bonora E. Psychological distress, self-efficacy and glycemic control in type 2 diabetes. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):300-306. doi: 10.1016/j.numecd.2017.01.006. Epub 2017 Jan 31.

  PMID: 28274728 BACKGROUND

• Dennick K, Sturt J, Hessler D, et al. High rates of elevated diabetes distress in research populations: A systematic review and meta-analysis. International Diabetes Nursing. 2015;12(3):93-107.

  BACKGROUND

• Fisher L, Skaff MM, Mullan JT, Arean P, Mohr D, Masharani U, Glasgow R, Laurencin G. Clinical depression versus distress among patients with type 2 diabetes: not just a question of semantics. Diabetes Care. 2007 Mar;30(3):542-8. doi: 10.2337/dc06-1614.

  PMID: 17327318 BACKGROUND

• Fisher L, Gonzalez JS, Polonsky WH. The confusing tale of depression and distress in patients with diabetes: a call for greater clarity and precision. Diabet Med. 2014 Jul;31(7):764-72. doi: 10.1111/dme.12428.

  PMID: 24606397 BACKGROUND

• Walker RJ, Strom Williams J, Egede LE. Influence of Race, Ethnicity and Social Determinants of Health on Diabetes Outcomes. Am J Med Sci. 2016 Apr;351(4):366-73. doi: 10.1016/j.amjms.2016.01.008.

  PMID: 27079342 BACKGROUND

• Hill-Briggs F, Adler NE, Berkowitz SA, Chin MH, Gary-Webb TL, Navas-Acien A, Thornton PL, Haire-Joshu D. Social Determinants of Health and Diabetes: A Scientific Review. Diabetes Care. 2020 Nov 2;44(1):258-79. doi: 10.2337/dci20-0053. Online ahead of print. No abstract available.

  PMID: 33139407 BACKGROUND

• Centers for Disease Control and Prevention. National diabetes statistics report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services. 2020:12- 15.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Arshiya Baig, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Danielle Hessler Jones, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abby Sr. Research Project Manager, MSW

CONTACT

773-834-5646; abigail.durgan@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)