Study of emotional distress in a comparative effectiveness trial of diabetes treatments: Rationale and design

Abstract

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 GRADE Study (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is generating prospective data that will provide a unique opportunity to examine the relationships between emotional distress, diabetes treatment, and outcomes in an experimental design. The GRADE study is a randomized clinical trial that will compare the metabolic effects of four common anti-hyperglycemic drugs when combined with metformin. This sub-study recruited a subset (n = 1739) of GRADE participants and will examine patient-level variation in baseline emotional distress as a predictor of glycemic control and other health outcomes, independent of treatment effects. The study will also provide an experimental examination of treatment regimen effects on emotional distress over time as part of the overall evaluation of comparative effectiveness. Evaluation of emotional distress using validated measures will allow us to disentangle the roles of depressive symptoms and diabetes distress, factors that share significant overlap but require distinct approaches to screening and treatment. Study findings may directly influence practice decisions regarding screening and treatment for emotional distress as part of diabetes care. ClinicalTrials.gov Identifier: NCT01794143.

Keywords: Depression; Diabetes; Diabetes distress; Emotional distress; Inflammation.

Copyright © 2021 Elsevier Inc. All rights reserved.

Figures

Fig. 1.

GRADE emotional distress sub-study conceptual framework.

Fig. 2.

Emotional Distress (EDS) substudy overview. At semi-annual and annual visits, the ADA booklet Diabetes & Your Emotional Health was provided to positive screens, interested participants, and any participants clinical site research staff judged might benefit [20]. * Diabetes Treatment Satisfaction Questionnaire (DTSQ) completed as part of GRADE Protocol at baseline, 6-, and 12-month visits. For EDS participants, the DTSQ was also completed at the 18, 24, 30, and 36-month visits [21].