Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes

Part of paid clinical trials in New York, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT05000021
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring — BEHAVIORAL
    CBT-DD consists of approximately 10 individual sessions of CBT delivered virtually by trained protocol therapists, conducted over the course of approximately 12 weeks. The CBT-DD 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. CBT-DD 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 diabetes distress, along with self-management information and treatment options to discuss with providers will also be provided.

Study Details

This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to commercial FDA-approved CGM only in a randomized controlled clinical trial. The investigators' central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. The investigators propose to recruit 93 adults (age 18-64) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, the investigators plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.

Key Dates

Start date
Jun 27, 2022
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
93 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring
    Participants randomized to this arm will receive Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD), 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

Diabetes Distress Levels [ Time Frame: Baseline and 3 months post-intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yeshiva UniversityNew YorkNew York10033
Jeffrey Gonzalez, PhD
[email protected]
646-592-4376
Jeffrey Gonzalez, PhD (PRINCIPAL_INVESTIGATOR)
Albert Einstein College of MedicineThe BronxNew York10461
Keyla Ordonez, BS
[email protected]
631-747-9325
Jeffrey Gonzalez, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Yeshiva University· New York, NYAlbert Einstein College of Medicine· The Bronx, NY

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