Actively Recruiting
Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
Led by University of North Carolina, Chapel Hill · Updated on 2025-10-29
200
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
A
American Diabetes Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.
CONDITIONS
Official Title
Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 30 years and older
- Type 1 diabetes or latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
- Elevated diabetes distress, defined as a score >= 2.0 on the T1-DDAS core scale
- English speaking
You will not qualify if you...
- Do not receive diabetes care at UNC Endocrinology at Eastowne
- Cannot commit to the pre-scheduled weekly, virtual sessions
- Diagnosis of any major medical or psychiatric condition that would preclude participation
- Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
- Visual or auditory impairment that would interfere with participation in a group intervention
- Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
A
Angela Fruik, MPH, RD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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