Recruiting

Telemedicine CBT

Sponsor:

Albert Einstein College of Medicine

Code:

NCT05734313

Conditions

Diabetes

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Unified protocol for cognitive behavioral therapy (UP-CBT)

Continuous Glucose Monitoring (CGM)

Study Details

Brief 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

Diabetes

Type 1 Diabetes

Study ID

NCT05734313

Start date

Mar 31, 2023

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring

Participants randomized to this arm will receive the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.

active comparator: Continuous Glucose Monitoring (CGM) Only

Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.

Interventions

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.

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 outcome measure

  • Anxiety symptom severity [ Time Frame: Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline ]
  • Depressive symptom severity [ Time Frame: Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline ]

Central Contacts and Locations

Central contacts

Jeffrey Gonzalez, PhD

646-592-4506jeffrey.gonzalez@yu.edu

Keyla Ordonez, BS

631-747-9325keyla.ordonez@einsteinmed.edu

Locations

Boston University

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Todd Farchione, PhD

tfarchio@bu.edu

Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Contacts

Keyla Ordonez, BS

631-747-9325keyla.ordonez@einsteinmed.edu

Principal Investigator:

Jeffrey Gonzalez, PhD

More Information

Sponsor

Albert Einstein College of Medicine

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • Diabetes
  • Type 1 Diabetes
  • Depression
  • Anxiety
  • Diabetes Distress
  • Diabetes Management
  • Diabetes Self-Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albert Einstein College of Medicine on 2025-10-30.