NCT06405373 Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
| NCT ID | NCT06405373 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Diabetes type1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-10-01 with a primary completion date of 2027-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Anna Kahkoska, MD, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06405373 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Diabetes type1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06405373 currently recruiting?
Yes, NCT06405373 is actively recruiting participants. Contact the research team at angela.fruik@unc.edu for enrollment information.
Where is the NCT06405373 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06405373 clinical trial?
NCT06405373 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Anna Kahkoska, MD, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 200 participants.
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