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

NCT06912737 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Interventions

BEHAVIORAL

Group Emotion Focused Behavioral Intervention (G-EFBI)

Group EFBI (G-EFBI) is aimed at assisting people with T2D to gain knowledge about emotions and improve their ability to regulate and manage their emotions.

BEHAVIORAL

Group - With Every Heartbeat is Life (G-WEHL)

G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06912737 on ClinicalTrials.gov