Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
Eligible age
30+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of North Carolina, Chapel Hill
You may qualify if…
- ✓ 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 may not qualify if…
- ✕ Does 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
Where it's recruiting
Chapel Hill
Source: ClinicalTrials.gov · NCT06405373 · last updated 2025-10-29