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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT05734313
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Unified protocol for cognitive behavioral therapy (UP-CBT) — BEHAVIORAL
    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) — DEVICE
    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.

Study Details

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 Dates

Start date
Mar 31, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston UniversityBostonMassachusetts02215
Todd Farchione, PhD
[email protected]
Albert Einstein College of MedicineThe BronxNew York10461
Keyla Ordonez, BS
[email protected]
631-747-9325
Jeffrey Gonzalez, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Boston University· Boston, MAAlbert Einstein College of Medicine· The Bronx, NY

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