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

Running, not enrolling · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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 facts

Study ID

NCT05000021

Run by

Albert Einstein College of Medicine

People needed

96

Starts

2022-06-27

Expected to finish

2027-07-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 Diabetes (T1D) duration ≥6 months
• English or Spanish speaking
• At least moderate Diabetes Distress (DD) (score of ≥2 on T1D-Diabetes Distress Scale)
• Stable insulin treatment regimen (insulin prescription, use of pump, etc.) for at least 3 months prior to study enrollment

You may not qualify if…

• Comorbid psychiatric condition, including depression, anxiety, or suicidality, which may be independently associated with the main outcomes of DD or glycemic control. Comorbid psychiatric conditions listed above are being excluded because CBT-DD currently centers on mitigating specifically diabetes distress to improve glycemic outcomes
• In treatment for a psychological condition within the last 6 months or on a non-stable dose of psychiatric medication over the last 2 months
• Developmental or sensory disability interfering with participation
• Current pregnancy, as self-management and glycemic goals differ
• Participation in another behavioral intervention study
• Use of non-insulin medications or recent medical procedures that would impact glycemic control or use of CGM over the study
• Minors
• Subjects who do have the capacity to consent

Where it is running

• Yeshiva University — New York, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.