Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.
Launched by OHIO STATE UNIVERSITY · Apr 2, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a group therapy approach designed to help individuals with Type 2 Diabetes (T2D) who are experiencing emotional distress related to their condition. The goal is to see if this group intervention can improve both emotional well-being and blood sugar control, as measured by a test called A1c. Researchers believe that managing emotions better can help patients stick to their diabetes treatment plans, ultimately leading to healthier outcomes.
To be eligible for this study, participants must be adults over 18 with a confirmed diagnosis of T2D for at least one year, and they should be feeling significant distress related to their diabetes. They must also have a specific level of A1c that indicates their blood sugar is not well-controlled. Participants will be part of group sessions where they will learn skills to manage their emotions and cope better with their diabetes. The study is not yet recruiting, but if you're interested, it’s important to know that you will need to be able to read English and provide informed consent to participate.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Male and female adults with documented diagnosis of T2D for at least one year.
- • 2. Age \> 18 years of age.
- • 3. Diabetes Distress Scale score \> 2.0 on any DDS subscale.
- • 4. A1c \> 7.5 (with hemoglobin in the normal range).
- • 5. PHQ-9 Depression score \< 15.
- • 6. Stable medical co-morbid conditions.
- • 7. Absence of a psychotic disorder or an intellectual disability.
- • 8. Able to read English.
- • 9. Able to give informed consent.
- Exclusion Criteria:
- • 1. Male and female adults with documented diagnosis of T2D for less than one year.
- • 2. Age \< 18 years of age.
- • 3. Diabetes Distress Scale score \< 2.0 on all DDS subscales.
- • 4. A1c \< 7.5 (with hemoglobin in the normal range).
- • 5. PHQ-9 Depression score \> 15.
- • 6. Unstable medical co-morbid conditions (e.g., hospitalization in past three months).
- • 7. Presence of a psychotic disorder or an intellectual disability.
- • 8. Initiation of psychotherapy or pharmacotherapy for emotional issues within three months of study entry.
- • 9. Unable to read English.
- • 10. Unable to give informed consent.
About Ohio State University
The Ohio State University (OSU) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a commitment to improving patient care and outcomes, OSU leverages its extensive resources, interdisciplinary collaboration, and expertise in diverse medical fields. The university fosters an environment of rigorous scientific inquiry, ensuring that clinical trials are conducted with the highest ethical standards and adherence to regulatory guidelines. Through its Clinical Trials Office, OSU aims to translate groundbreaking research into practical applications, benefiting both local and global communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported