NCT06405386Completed
Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes
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 5 Dec 2024
Brief summary (registry, in English)
This study is designed to test the feasibility and acceptability of 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. This is a pilot study, which will enroll a small group of participants to enroll and give feedback on their experience. 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 intervention, participants will attend focus groups and fill out anonymous qualitative surveys to give feedback on their experience. Results of the pilot will inform and improve an upcoming research study of the same design.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 6 May 2024
- Start date
- Jul 2024
- Primary completion date
- Oct 2024
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Type 1 diabetes
- NCT number
- NCT06405386
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From Jul 2024 to the primary completion date, Oct 2024
- 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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.