EMOTIONAL DISTRESS IN A COMPARATIVE EFFECTIVE TRIAL OF DIABETES TREATMENTS (EDS)
Principal Investigator: Heidi Krause-Steinrauf, M.S.
Emotional distress, including depression and diabetes-specific distress (e.g., feeling overwhelmed by living with diabetes, feelings of failure related to diabetes self-care), is a significant and prevalent problem for patients with type 2 diabetes. Both depression and diabetes distress have been associated with metabolic/glycemic control, diabetes complications, mortality, and quality of life. Recent findings further suggest that risk for emotional distress is influenced by diabetes treatment. The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) is generating prospective data that provide a unique opportunity to examine the relationships between emotional distress, diabetes treatment, and outcomes in an experimental design.
The Emotional Distress in a Comparative Effective Trial of Diabetes Treatments (EDS) examines patient-level variation in baseline emotional distress as a predictor of glycemic control and other health outcomes, independent of treatment effects. The substudy will collect data via a self-administered questionnaire and a small blood sample tested for high-sensitivity C-Reactive Protein (hs-CRP, a protein produced by the liver to measure levels of inflammation in the body) to assess emotional distress among the four treatment assignment groups in GRADE. Measurements will be completed at baseline and every 6 months during study follow-up. Up to 2250 consenting participants will undergo the substudy assessments.
The data from this substudy will be used to examine the roles of depressive symptoms and diabetes distress, factors that share significant overlap but require distinct approaches to screening and treatment. Substudy findings will directly inform practice decisions regarding screening and treatment for emotional distress as part of diabetes care. This trial is funded by NIDDK, and is being conducted at about 2/3rd of the GRADE Clinical Centers.
Funded by NIDDK Grant R01DK104845, 2015-2020.)