RecruitingNot ApplicableNCT05734313

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

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


Sponsor

Albert Einstein College of Medicine

Enrollment

94 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a telehealth version of cognitive behavioural therapy (CBT) — delivered over video or phone — for adults with type 1 diabetes (T1D) who are also experiencing anxiety or depression. Managing diabetes can be mentally exhausting, and mental health conditions make blood sugar control harder. This program, called the Unified Protocol, is designed to treat anxiety and depression while also supporting diabetes self-management. **You may be eligible if...** - You are 18 to 64 years old - You have had type 1 diabetes for at least 6 months - You speak English or Spanish - You have been diagnosed with an anxiety or depressive disorder (through a structured interview) **You may NOT be eligible if...** - You have a developmental disability or sensory impairment that prevents participation - You are currently pregnant - You have bipolar disorder, psychosis, severe eating disorders, severe substance use disorder, or active suicidal risk - You have recently started a new psychiatric medication and are not yet on a stable dose for 6 weeks - You have received CBT in the past year or are planning to start CBT 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.

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Interventions

BEHAVIORALUnified protocol for cognitive behavioral therapy (UP-CBT)

UP-CBT consists of approximately 16 individual sessions of CBT, conducted over the course of approximately 20 weeks. The UP-CBT 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. UP-CBT 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 anxiety and depressive disorders, along with self-management information and treatment options to discuss with providers will also be provided.


Locations(2)

Boston University

Boston, Massachusetts, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

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NCT05734313


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