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NCT06405386 · ClinicalTrials.gov registry record · NA
Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT06405386: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT06405386 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06405386, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score \>= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as
Interventions
- BEHAVIORAL ReCharge
- BEHAVIORAL TakeCharge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-07-22 |
| Est. Completion | 2024-10-15 |
| Phase | NA |
What the finished NCT06405386 record still lists
NCT06405386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which ReCharge is the first listed.
NCT06405386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06405386 about?
NCT06405386 is a clinical study titled "Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes". 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...
What is the current status of trial NCT06405386?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2024-07-22. Estimated completion is 2024-10-15.
What interventions are being tested in trial NCT06405386?
The interventions under investigation include: ReCharge (BEHAVIORAL), TakeCharge (BEHAVIORAL).
Who is sponsoring clinical trial NCT06405386?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06405386's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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