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

NARecruitingINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
DiabetesType 1 Diabetes
Interventions
BEHAVIORAL

Unified 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.

DEVICE

Continuous 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.

Trial Locations (2)

10461

RECRUITING

Albert Einstein College of Medicine, The Bronx

02215

RECRUITING

Boston University, Boston

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

DexCom, Inc.

INDUSTRY

lead

Albert Einstein College of Medicine

OTHER

NCT05734313 - Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression | Biotech Hunter | Biotech Hunter