RecruitingNot ApplicableNCT05000021

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

Sponsor

Albert Einstein College of Medicine

Enrollment

93 participants

Start Date

Jun 27, 2022

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of talk therapy called Cognitive Behavioral Therapy (CBT) to help adults with Type 1 Diabetes manage the emotional stress and worry that often comes with managing diabetes. The goal is to reduce diabetes-related distress and improve blood sugar control. **You may be eligible if...** - You have had Type 1 Diabetes for at least 6 months - You speak English or Spanish - You are experiencing at least moderate diabetes-related distress (feeling overwhelmed or burdened by managing your diabetes) - Your insulin treatment plan has been stable for at least 3 months **You may NOT be eligible if...** - You have a current mental health condition such as depression, anxiety, or thoughts of self-harm - You have been in psychological treatment or changed psychiatric medications in the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALCognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring

CBT-DD consists of approximately 10 individual sessions of CBT delivered virtually by trained protocol therapists, conducted over the course of approximately 12 weeks. The CBT-DD consists of 5 core modules targeting negative emotionality and aversive reactions to emotional experiences. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. The final module consists of relapse prevention. CBT-DD sessions will integrate a review of Continuous Glucose Monitoring (CGM) data and feedback will be provided by the therapist.

DEVICEContinuous Glucose Monitoring (CGM)

Use of commercially available, FDA-approved continuous glucose monitoring (CGM) for 6 months post-randomization. Usual diabetes care will continue and participants can initiate a CGM review from their healthcare providers, as desired. In addition, a nurse practitioner with expertise in CGM will train each participant via video recordings in the proper placement of the device, and technical issues, and provide basic teaching at the beginning of the trial on interpretation of CGM data and self-titration of insulin/self-management. Written materials and online resources for recognizing and managing diabetes distress, along with self-management information and treatment options to discuss with providers will also be provided.