Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression

Recruiting now · Not applicable

Conditions studied: Diabetes, Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT05734313

Run by

Albert Einstein College of Medicine

People needed

94

Starts

2023-03-31

Expected to finish

2027-12-01

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Boston University — Boston, Massachusetts, United States (enrolling)
• Albert Einstein College of Medicine — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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