Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression (UP-CBT)

Albert Einstein College of Medicine

Status: Enrolling

Conditions: Diabetes; Type 1 Diabetes

Treatments: Device: Continuous Glucose Monitoring (CGM); Behavioral: Unified protocol for cognitive behavioral therapy (UP-CBT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05734313

2022-14517

Details and patient eligibility

About

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.

Full description

The efficacy of the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) combined with commercial FDA-approved Continuous Glucose Monitoring (CGM) will be tested in comparison to CGM only in a randomized controlled clinical trial. The central hypothesis is that the addition of the UP-CBT intervention will yield clinically significant improvements in anxiety and depressive symptom severity and glycemic control relative to CGM alone. We will recruit 94 adults (age 18-64) with suboptimally controlled type 1 diabetes and an anxiety or depressive disorder from a national population for an entirely virtual 12-month study over five years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of hemoglobin A1c (HbA1c) for glycemic control and validated patient-reported outcome (PRO) surveys, the study integrates momentary psychological and behavioral data via smartphone-based ecological momentary assessment (EMA) with CGM data to assess day-to-day changes in affect, self-management, and glycemia over the course of the trial.

Qualitative information will be collected from people with Type 1 Diabetes (T1D) ages 35-64 to solicit suggestions and inform future study decisions. We will create 2-4 focus groups to ask their impressions about our current study and to explore key factors like establishing adult care and attending medical appointments, disease self-management, and adjusting to chronic disease. We will compare interview responses from participant groups who have high vs. low social needs and poor vs. good glycemic control.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes (T1D) duration ≥ 6 months
• 18-64 years old
• HbA1c = 7.5-14%
• English- or Spanish-speaking
• Anxiety or depressive mood disorder as per structured diagnostic interview.

Exclusion criteria

• Developmental or sensory disability interfering with participation
• Current pregnancy
• Bipolar disorders, psychotic disorders, severe eating disorders, severe substance abuse disorders, or acute suicidal risk or self-harm
• Use of medications or recent medical procedures that would impact glycemic control or use of continuous glucose monitoring (CGM) over the study
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring

Experimental group

Description:

Participants randomized to this arm will receive the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.

Treatment:

Behavioral: Unified protocol for cognitive behavioral therapy (UP-CBT)

Device: Continuous Glucose Monitoring (CGM)

Continuous Glucose Monitoring (CGM) Only

Active Comparator group

Description:

Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.

Treatment:

Device: Continuous Glucose Monitoring (CGM)