Fusing Rapid-cycle Testing and Adaptive Trial Designs to Translate and Individualize Behavioral Interventions for Adults with Type 1 Diabetes Distress

What this Trial Is About

Researchers are evaluating two different virtual group-based behavioral interventions to reduce diabetes distress, which includes the emotional burdens and challenges faced by adults living with type 1 diabetes. This pragmatic trial uses a precision medicine design called a Sequential Multiple Assignment Randomized Trial (SMART) to compare an emotions-focused approach and a problem-solving approach. The study aims to find the most effective methods to help adults 30 years and older manage diabetes distress and to personalize treatments based on individual responses. Participants will be randomly assigned to one of two 5-week primary virtual interventions: ReCharge, which focuses on Acceptance and Commitment Therapy (ACT) to lessen emotional distress, or TakeCharge, which focuses on problem-solving skills to improve diabetes management. After completing the primary intervention, participants' responses will be assessed through surveys. Those who do not respond will be re-randomized to one of two supplementary 5-week interventions involving three individualized virtual sessions, allowing further practice of either the emotional or problem-solving methods. During the 12-week study period, all interventions and assessments are conducted virtually. Participants will complete various surveys and assessments at baseline, 6 weeks, and 12 weeks to measure changes in diabetes distress, perceived stress, quality of life, confidence in diabetes management, self-compassion, hypoglycemic attitudes, and blood sugar control through HbA1c and continuous glucose monitoring metrics. The study also gathers feedback to improve intervention implementation and aims to support future wider integration of these approaches into routine diabetes care.

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