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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ReCharge
  • TakeCharge

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

American Diabetes Association

Collaborator