ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
Who is this study for? Diverse adults with type 1 diabetes
What treatments are being studied? ACT1VATE
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This research will compare a psychological intervention (ACT1VATE) versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Spanish or English-speaking
• Type 1 diabetes
• Glycosylated Hemoglobin (HbA1c) 7.5% - 12.5% in last 90 days
• Screen positive for diabetes distress
Locations
United States
California
Scripps Whittier Diabetes Institute
RECRUITING
San Diego
Contact Information
Primary
Haley Sandoval
sandoval.haley@scrippshealth.org
970-497-6701
Backup
Addie Fortmann, PhD
fortmann.adelaide@scrippshealth.org
858-922-2276
Time Frame
Start Date: 2021-10-25
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 250
Treatments
Experimental: ACT1VATE
Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.
Active_comparator: DSME/S (usual care)
Participants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME/S).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Scripps Whittier Diabetes Institute