NCT06405373Recruiting
Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
Source: ClinicalTrials.gov · Last updated 29 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 6 May 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 15 Sept 2027
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Type 1 diabetes
- NCT number
- NCT06405373
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Oct 2024 to the primary completion date, 15 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
Other illness
- Does not receive diabetes care at UNC Endocrinology at Eastowne
- 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
Other
- Cannot commit to the pre-scheduled weekly, virtual sessions
Who the study is looking for
- 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
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.