Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and D
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.
| Condition(s) | Diabetes, Type 1 Diabetes |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Lead sponsor | Albert Einstein College of Medicine |
| Locations | Boston, Massachusetts, United States; The Bronx, New York, United States |
| Start date | 2023-03-31 |
| NCT ID | NCT05734313 |
| Official listing | https://clinicaltrials.gov/study/NCT05734313 |