RecruitingNot ApplicableNCT06405373

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

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

Sponsor

University of North Carolina, Chapel Hill

Enrollment

200 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Distress, Emotional Diabetes Mellitus, Type 1 Diabetes type1 Diabetes, Autoimmune

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

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing behavioral strategies to help reduce "diabetes distress" — the emotional burden, stress, and frustration that many people with Type 1 diabetes experience in managing their condition daily. The interventions are delivered virtually in weekly group sessions. **You may be eligible if...** - You are 30 years or older with Type 1 diabetes or LADA (a slow-onset autoimmune diabetes managed like Type 1) - You experience elevated diabetes distress (a score of 2.0 or higher on a standard scale) - You speak English - You receive your diabetes care at UNC Endocrinology at Eastowne **You may NOT be eligible if...** - You cannot commit to weekly virtual sessions at the pre-scheduled times - You have a serious medical or psychiatric condition that would prevent participation - You have dementia or other significant memory impairment - You have visual or hearing problems that would prevent participation in an online group - You have been hospitalized for psychiatric care or attempted suicide in the past 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALReCharge

ReCharge is an emotions-focused intervention that utilizes core components of Acceptance and Commitment Therapy (ACT) to address and minimize diabetes distress. This 5-week, group-based, virtual intervention will include a stepwise process to address diabetes distress and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.

BEHAVIORALTakeCharge

TakeCharge is a problem-solving focused intervention that empowers participants to identify and make meaningful changes in their blood glucose management and other diabetes-related behaviors. This 5-week, group-based, virtual intervention will include a stepwise process to analyze data and resolve challenging situations surrounding diabetes management and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.