Telemedicine program for cognitive behavioral therapy targeting anxiety and depression in adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.