Behavioral approaches to reduce diabetes distress in adults with type 1 diabetes
Official title: 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
Run by University of North Carolina, Chapel Hill · NCT06405373 · Data updated 2026-11-12
This study tests two different group programs to see if they can help adults with type 1 diabetes feel less stressed about managing their condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | September 15, 2027 |
| Study ends | September 15, 2027 |
| Registry record updated | October 29, 2025 |
| Trial ID | NCT06405373 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 30 years and older with type 1 diabetes or latent autoimmune diabetes in adults experiencing elevated diabetes distress.
✕Probably not a fit
Patients who are unable to participate in virtual sessions or have major medical or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares two behavioral interventions aimed at reducing diabetes distress in adults with type 1 diabetes. Participants will be randomly assigned to either an emotions-focused or a problem-solving approach delivered in a virtual group format. After the initial intervention, those who do not respond will receive individualized sessions based on their needs. The study aims to evaluate the effectiveness of these approaches over a 12-week period and to identify optimal treatment strategies for individuals based on their responses.
Why it matters
Potential benefit: If successful, this study could significantly improve the emotional well-being and management of diabetes for patients with type 1 diabetes.
How similar studies have gone: Other studies have shown promise in using behavioral interventions to address diabetes distress, indicating that this approach is both relevant and potentially effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Anna Kahkoska, MD, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Angela Fruik, MPH, RD
- Email: angela.fruik@unc.edu
- Phone: 919-962-6348
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.