RECRUITING

Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes

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 proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to commercial FDA-approved CGM only in a randomized controlled clinical trial. The investigators' central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. The investigators propose to recruit 93 adults (age 18-64) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, the investigators plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.

Official Title

Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes

Quick Facts

Study Start:2022-06-27
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05000021

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. * 18-64 years old
  2. * HbA1c \>7.5%
  3. * Diabetes Duration \>6 months
  4. * Diabetes Distress level \>40
  1. * Comorbid psychiatric condition (e.g. depression, anxiety, or suicidality).
  2. * In treatment for a psychological condition within the last 6 months
  3. * On a non-stable dose of psychiatric medication over the past 2 months
  4. * Developmental or sensory disability interfering with participation
  5. * Current pregnancy, as self-management and glycemic goals differ
  6. * Participations in another behavioral intervention study

Contacts and Locations

Study Contact

Shivani Agarwal, MD, MPH
CONTACT
844-556-6683
Shivani.agarwal@einsteinmed.org
Jeffrey Gonzalez, PhD
CONTACT
646-592-4376
jeffrey.gonzalez@yu.edu

Principal Investigator

Shivani Agarwal, MD, MPH
PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Jeffrey Gonzalez, PhD
PRINCIPAL_INVESTIGATOR
Yeshiva University

Study Locations (Sites)

Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Yeshiva University
New York, New York, 10033
United States

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

  • Shivani Agarwal, MD, MPH, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine
  • Jeffrey Gonzalez, PhD, PRINCIPAL_INVESTIGATOR, Yeshiva University

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 Date2022-06-27
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-06-27
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • diabetes
  • diabetes distress
  • young adult
  • cognitive behavioral therapy

Additional Relevant MeSH Terms

  • Type 1 Diabetes