RECRUITING
I'm interested ...!!
Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression
This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in adults with type 1 diabetes.
Conditions:
🦠 Diabetes 🦠 Type 1 Diabetes
🗓️ Study Start (Actual) 31 October 2023
🗓️ Primary Completion (Estimated) December 2027
✅ Study Completion (Estimated) December 2027
👥 Enrollment (Estimated) 94
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States
📍 Bronx, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Type 1 diabetes (T1D) duration ≥ 6 months
    • * 18-64 years old
    • * HbA1c = 7.5-14%
    • * 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.
Ages Eligible for Study: 18 Years to 64 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 February 2023
  • First Submitted that Met QC Criteria 16 February 2023
  • First Posted 17 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 July 2024
  • Last Update Posted 24 July 2024
  • Last Verified July 2024
I'm interested ...!!