RECRUITING

Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression

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Conditions

DiabetesType 1 DiabetesDepressionAnxietyDiabetes DistressDiabetes ManagementDiabetes Self-Care

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression in Young Adults With Type 1 Diabetes

Quick Facts

Study Start:2023-10-31
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05734313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Type 1 diabetes (T1D) duration ≥ 6 months
  2. * 18-64 years old
  3. * HbA1c = 7.5-14%
  4. * English- or Spanish-speaking
  5. * Anxiety or depressive mood disorder as per structured diagnostic interview.
  1. * Developmental or sensory disability interfering with participation
  2. * Current pregnancy
  3. * Bipolar disorders, psychotic disorders, severe eating disorders, severe substance abuse disorders, or acute suicidal risk or self-harm
  4. * Use of medications or recent medical procedures that would impact glycemic control or use of continuous glucose monitoring (CGM) over the study
  5. * 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.

Contacts and Locations

Study Contact

Jeffrey Gonzalez, PhD
CONTACT
646-592-4506
jeffrey.gonzalez@yu.edu
Molly Finnan, MPH
CONTACT
843-422-3861
molly.finnan@einsteinmed.edu

Principal Investigator

Jeffrey Gonzalez, PhD
PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine

Study Locations (Sites)

Boston University
Boston, Massachusetts, 02215
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

  • Jeffrey Gonzalez, PhD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine

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

Study Start Date2023-10-31
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-10-31
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • Type 1 Diabetes
  • Depression
  • Anxiety
  • Diabetes Distress
  • Diabetes Management
  • Diabetes Self-Care

Additional Relevant MeSH Terms

  • Diabetes
  • Type 1 Diabetes