Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART

Recruiting now · Not applicable

Conditions studied: Diabetes type1, Diabetes Mellitus, Type 1, Diabetes, Autoimmune, Diabetes Mellitus, Distress, Emotional

In brief

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.

Key facts

Study ID

NCT06405373

Run by

University of North Carolina, Chapel Hill

People needed

200

Starts

2024-10-01

Expected to finish

2027-09-15

Last updated by the study team

2025-10-29

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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 is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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