Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression in Young Adults With Type 1 Diabetes
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in adults with type 1 diabetes.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• Type 1 diabetes (T1D) duration ≥ 6 months
• 18-64 years old
• HbA1c = 7.5-14%
• English- or Spanish-speaking
• Anxiety or depressive mood disorder as per structured diagnostic interview.
Locations
United States
Massachusetts
Boston University
RECRUITING
Boston
New York
Albert Einstein College of Medicine
RECRUITING
The Bronx
Contact Information
Primary
Jeffrey Gonzalez, PhD
jeffrey.gonzalez@yu.edu
646-592-4506
Backup
Molly Finnan, MPH
molly.finnan@einsteinmed.edu
843-422-3861
Time Frame
Start Date: 2023-03-31
Estimated Completion Date: 2027-12
Participants
Target number of participants: 94
Treatments
Experimental: Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring
Participants randomized to this arm will receive the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.
Active_comparator: Continuous Glucose Monitoring (CGM) Only
Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.
Related Therapeutic Areas
Sponsors
Collaborators: Juvenile Diabetes Research Foundation, DexCom, Inc.
Leads: Albert Einstein College of Medicine