Telemedicine program for cognitive behavioral therapy targeting anxiety and depression in adults with type 1 diabetes
Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression in Young Adults With Type 1 Diabetes
This study tests whether a telemedicine program that combines therapy for anxiety and depression with continuous glucose monitoring can help adults with type 1 diabetes feel better compared to just using glucose monitoring alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Albert Einstein College of Medicine Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05734313 on ClinicalTrials.gov |
What this trial studies
This project evaluates a telemedicine-delivered Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) combined with Continuous Glucose Monitoring (CGM) to address anxiety and depressive symptoms in adults with type 1 diabetes. The study will compare the effectiveness of UP-CBT plus CGM against CGM alone in a randomized controlled trial involving 94 participants aged 18-64. Over a 12-month period, the trial will utilize validated surveys and smartphone-based assessments to monitor psychological and behavioral changes alongside glycemic control. The study aims to recruit a diverse population, focusing on racial and ethnic minorities, to gather qualitative insights for future research.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-64 with type 1 diabetes, experiencing anxiety or depressive disorders, and with suboptimal glycemic control.
Not a fit: Patients with severe mental health disorders, developmental disabilities, or those who have recently received cognitive behavioral therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health and glycemic control in patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promise in using telemedicine and cognitive behavioral therapy for mental health issues, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 diabetes (T1D) duration ≥ 6 months * 18-64 years old * English- or Spanish-speaking * Anxiety or depressive mood disorder as per structured diagnostic interview. Exclusion Criteria: * Developmental or sensory disability interfering with participation * Current pregnancy * Bipolar disorders, psychotic disorders, severe eating disorders, severe substance abuse disorders, or acute suicidal risk or self-harm * Use of medications or recent medical procedures that would impact glycemic control or use of continuous glucose monitoring (CGM) over the study * Received cognitive behavioral therapy (CBT) in last year or plans to initiate CBT; (6) temporary exclusion for recent initiation of psychotropic medication - must be on a stable dose for 6 weeks prior to enrollment.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Boston University — Boston, Massachusetts, United States (Recruiting)
- Albert Einstein College of Medicine — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Gonzalez, PhD — Albert Einstein College of Medicine
- Study coordinator: Jeffrey Gonzalez, PhD
- Email: jeffrey.gonzalez@yu.edu
- Phone: 646-592-4506
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.