Using therapy to reduce diabetes distress in young adults with type 1 diabetes
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
This study is testing if a combination of online therapy and continuous glucose monitoring can help young adults with type 1 diabetes feel less stressed about their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 93 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Albert Einstein College of Medicine Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT05000021 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of telemedicine-delivered cognitive-behavioral therapy (CBT) combined with continuous glucose monitoring (CGM) to alleviate diabetes distress in young adults with type 1 diabetes. The study will involve a randomized controlled trial comparing the CBT intervention to CGM alone over a 6-month period. Participants will be monitored for changes in diabetes distress and glycemic control, with data collected through ecological momentary assessments and standard HbA1c measurements. The study will also include qualitative feedback from older adults with type 1 diabetes to inform future research.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18-64 with type 1 diabetes, experiencing high levels of diabetes distress and elevated HbA1c levels.
Not a fit: Patients with comorbid psychiatric conditions or those currently receiving treatment for psychological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health and glycemic control for young adults living with type 1 diabetes.
How similar studies have performed: Previous studies have shown promise in using cognitive-behavioral therapy for diabetes distress, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
New York, New York and 1 other locations
- Yeshiva University — New York, New York, United States (Recruiting)
- Albert Einstein College of Medicine — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Gonzalez, PhD — Yeshiva University
- Study coordinator: Jeffrey Gonzalez, PhD
- Email: jeffrey.gonzalez@yu.edu
- Phone: 646-592-4376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.