Diabetes distress (DD) refers to the often hidden emotional burdens, stresses, and worries that result from managing a demanding, progressive, and chronic disease like type 1 diabetes (T1D). DD is highly prevalent, with approximately 42% of T1D adults manifesting elevated DD; is distinct from clinical depression; tends to be chronic, rather than episodic; and has been significantly associated with poor glycemic control and problematic self-care behavior. Systematic reviews suggest the development of effective interventions for DD have been impeded by: the majority of interventions not targeting DD directly, instead delivering various forms of diabetes education and disease-management, few studies being grounded in a theoretical framework that drives an intervention strategy; study designs that rarely allow for direct comparison of different approaches to reduce DD; relatively few studies focused on T1D, and no study to date that has explored different approaches to DD reduction in ways that directly maximize improvements in glycemic control. To address these problems we propose a 3-arm clinical trial with T1D adults that uses theoretically supported, evidenced-based interventions to test the added value of a program that targets DD directly through emotion regulation strategies (TunedIn) and a unified DD and disease management intervention (FixIt) to reduce DD and improve glycemic control, relative to a traditional education/disease management intervention (StreamLine). The primary outcome is HbA1c. We will explore mediating pathways linking changes in DD with changes in HbA1c over time. The effect of selective moderating variables on intervention effectiveness will be assessed. Intervention costs and stakeholder input will inform dissemination and future program implementation.

Public Health Relevance

Diabetes distress (DD) refers to the common emotional burdens, stresses, and worries that result from managing a demanding chronic disease like type 1 diabetes. Most current programs that seek to reduce DD through diabetes-related education have met with mixed results. This project will test the added value of targeting DD directly through use of emotion regulation strategies and through a unified DD-targeted and disease management program, relative to a traditional disease management program. Our goal is to both maximize reductions in DD and improve glycemic control among adults with T1D.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
1R01DK121241-01
Application #
9741438
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Linder, Barbara
Project Start
2019-04-01
Project End
2023-03-31
Budget Start
2019-04-01
Budget End
2020-03-31
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Family Medicine
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94118