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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Angela Fruik, MPH, RD
angela.fruik@unc.edu
919-962-6348
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-09-15
Participants
Target number of participants: 200
Treatments
Experimental: ReCharge
Participants randomized to ReCharge will participate in an emotions-focused intervention facilitated by a mental health professional.
Experimental: TakeCharge
Participants randomized to TakeCharge will participate in a problem-solving focused intervention facilitated by a diabetes care professional.
Related Therapeutic Areas
Sponsors
Collaborators: American Diabetes Association
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov