Status:
NOT_YET_RECRUITING
Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 \<...
Detailed Description
This is an early-stage treatment development project proposing to conduct a modest randomized clinical trial of Group EFBI, vs. a Group Attentional Control Intervention, to collect feasibility, accept...
Eligibility Criteria
Inclusion
- Male and female adults with documented diagnosis of T2D for at least one year.
- Age \> 18 years of age.
- Diabetes Distress Scale score \> 2.0 on any DDS subscale.
- A1c \> 7.5 (with hemoglobin in the normal range).
- PHQ-9 Depression score \< 15.
- Stable medical co-morbid conditions.
- Absence of a psychotic disorder or an intellectual disability.
- Able to read English.
- Able to give informed consent.
Exclusion
- Male and female adults with documented diagnosis of T2D for less than one year.
- Age \< 18 years of age.
- Diabetes Distress Scale score \< 2.0 on all DDS subscales.
- A1c \< 7.5 (with hemoglobin in the normal range).
- PHQ-9 Depression score \> 15.
- Unstable medical co-morbid conditions (e.g., hospitalization in past three months).
- Presence of a psychotic disorder or an intellectual disability.
- Initiation of psychotherapy or pharmacotherapy for emotional issues within three months of study entry.
- Unable to read English.
- Unable to give informed consent.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06912737
Start Date
September 1 2025
End Date
January 31 2028
Last Update
April 6 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210