Clinical Trial

Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.

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Summary
T2D is a major public health problem and is currently the 7th leading cause of death in the US. Despite a range of efficacious treatments, less than 50% of patients achieve a glycemic target of A1c \< 7.0%, suggesting that this is due to difficulty with following medical regimens to reduce A1C levels. While a range of factors have been identified in this regard, we posit that a barrier to treatment are broad difficulty with emotional regulation that are not diagnosis-specific but lead to Diabetes Distress (DD) and difficulty in coping with medical regimens, and other aspects of diabetes self-care, in the context of the psychosocial stressors associated with T2D. Extant data suggests that sub-optimal emotional regulation (experience of intense emotion and skill at regulating emotion) is related to elevated DD and A1c levels, and that an Emotion-Focused Behavioral Intervention (EFBI) can reduce both DD and A1c levels in PWD with T2D. In this project we seek to take our one-to-one intervention, now adapted to a group intervention (G-EFBI) and collect feasibility, acceptability, and preliminary efficacy data to determine if G-EFBI is a feasible, acceptable and, possibly, efficacious intervention compared to an "Attentional Control" intervention in PWD with T2D and elevated DD and A1c levels.
Trial Details
NCT Number NCT06912737
Lead Sponsor Ohio State University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions T2DM (Type 2 Diabetes Mellitus)
Enrollment 120 participants
Start Date 2025-09-01
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-06