Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression
Recruiting · NCT05734313 · Interventional (participants receive a specific treatment) · Lead sponsor: Albert Einstein College of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Continuous Glucose Monitoring (CGM)Unified protocol for cognitive behavioral therapy (UP-CBT)
What this trial is about
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.
Who can take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Type 1 diabetes (T1D) duration ≥ 6 months
- 18-64 years old
- English- or Spanish-speaking
- Anxiety or depressive mood disorder as per structured diagnostic interview.
Exclusion criteria
- Developmental or sensory disability interfering with participation
- Current pregnancy
- Bipolar disorders, psychotic disorders, severe eating disorders, severe substance abuse disorders, or acute suicidal risk or self-harm
- Use of medications or recent medical procedures that would impact glycemic control or use of continuous glucose monitoring (CGM) over the study
- Received cognitive behavioral therapy (CBT) in last year or plans to initiate CBT; (6) temporary exclusion for recent initiation of psychotropic medication - must be on a stable dose for 6 weeks prior to enrollment.
Where it is running
2 locations listed across 2 US states.
- Boston University - Boston, Massachusetts, United States
- Albert Einstein College of Medicine - The Bronx, New York, United States