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

NCT05734313 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-10-30

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • DexCom, Inc.

    collaborator INDUSTRY

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Jeffrey Gonzalez, PhD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05734313 on ClinicalTrials.gov