Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes (NCT05000021)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).
Location: Yeshiva University — New York, New York
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Yeshiva University — New York, New York
- Albert Einstein College of Medicine — The Bronx, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.