RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

ReCharge

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.

BEHAVIORAL

TakeCharge

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.

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States