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Recruiting NCT06405373

Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART

◆ AI Clinical Summary

This study tests two different behavioral approaches to help adults with type 1 diabetes feel less stressed and worried about managing their condition. Diabetes distress refers to the emotional burden, concerns, and fears that come with living with diabetes day-to-day. The study will compare which approach works better at reducing these feelings.

Key Objective: This trial is testing whether behavioral approaches can significantly reduce the emotional stress and distress that people with type 1 diabetes experience.

Who to Consider: Adults with type 1 diabetes who experience stress, worry, or emotional burden related to managing their diabetes should consider enrolling.

Trial Parameters

Condition Diabetes type1
Sponsor University of North Carolina, Chapel Hill
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 30 Years
Max Age N/A
Start Date 2024-10-01
Completion 2027-09-15
Interventions
ReChargeTakeCharge

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

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