Actively Recruiting
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
Led by Albert Einstein College of Medicine · Updated on 2026-01-08
93
Participants Needed
2
Research Sites
205 weeks
Total Duration
On this page
Sponsors
A
Albert Einstein College of Medicine
Lead Sponsor
J
Juvenile Diabetes Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 1 diabetes for at least 6 months
- English or Spanish speaking
- At least moderate diabetes distress (score of 2 or higher on the T1D-Diabetes Distress Scale)
- Stable insulin treatment regimen for at least 3 months before enrollment
- Age between 18 and 64 years
You will not qualify if you...
- Comorbid psychiatric conditions like depression, anxiety, or suicidality
- Treatment for psychological conditions within the last 6 months or unstable psychiatric medication dose in last 2 months
- Developmental or sensory disabilities that interfere with participation
- Current pregnancy
- Participation in another behavioral intervention study
- Use of non-insulin medications or recent medical procedures affecting glycemic control or CGM use
- Minors under 18 years
- Lack of capacity to consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Yeshiva University
New York, New York, United States, 10033
Actively Recruiting
2
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
Actively Recruiting
Research Team
J
Jeffrey Gonzalez, PhD
CONTACT
K
Keyla Ordonez, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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