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

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.

ClinicalTrials.gov IDNCT05734313

PhaseNA

Enrollment94

SponsorAlbert Einstein College of Medicine

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Diabetes, Type 1 Diabetes

About this study

Interventions

Behavioral: Unified protocol for cognitive behavioral therapy (UP-CBT) — UP-CBT consists of approximately 16 individual sessions of CBT, conducted over the course of approximately 20 weeks. The UP-CBT consists of 5 core modules targeting negative emotionality and aversive reactions to emotional experiences. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. The final module consists of relapse prevention. UP-CBT sessions will integrate a review of Continuous Glucose Monitoring (CGM) data and feedback will be provided by the therapist.
Device: Continuous Glucose Monitoring (CGM) — Use of commercially available, FDA-approved continuous glucose monitoring (CGM) for 6 months post-randomization. Usual diabetes care will continue and participants can initiate a CGM review from their healthcare providers, as desired. In addition, a nurse practitioner with expertise in CGM will train each participant via video recordings in the proper placement of the device, and technical issues, and provide basic teaching at the beginning of the trial on interpretation of CGM data and self-titration of insulin/self-management. Written materials and online resources for recognizing and managing anxiety and depressive disorders, along with self-management information and treatment options to discuss with providers will also be provided.

Primary outcomes

Anxiety symptom severity (Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline)
Depressive symptom severity (Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline)

Eligibility information

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.

Study locations

Boston University, Boston, Massachusetts 02215 United States
Albert Einstein College of Medicine, The Bronx, New York 10461 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.