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

Not Applicable

Recruiting

• Conditions: Diabetes; Type 1 Diabetes
• Interventions: Behavioral: Unified protocol for cognitive behavioral therapy (UP-CBT); Device: Continuous Glucose Monitoring (CGM)

• Registration Number: NCT05734313
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Study Start: 2023-03-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring	Continuous Glucose Monitoring (CGM)	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.
Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring	Unified protocol for cognitive behavioral therapy (UP-CBT)	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.
Continuous Glucose Monitoring (CGM) Only	Continuous Glucose Monitoring (CGM)	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.

Primary Outcome Measures

Name	Time	Method
Anxiety symptom severity	6 months	Participant ratings will be conducted via video conference by clinicians blinded to the condition, using the Structured Interview Guide for the Hamilton Anxiety Rating Scales (SIGH-A). SIGH-A measures the severity of a patient's somatic and psychic anxiety based on 14 parameters including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each item is assigned a 5-point score ranging from 0 (not present) to 4 (severe) yielding an overall possible score of 0-56. Higher SIGH-A scores denote increased severity of anxiety.
Depressive symptom severity	6 months	Participant ratings will be conducted via video conference by clinicians blinded to the condition, using the Structured Interview Guide for the Hamilton Depression Rating Scales (SIGH-D). SIGH-D is a 29-item clinical interview that expands the 21-item Hamilton Depression Rating Scale for Depression (HAM-D) to include eight items assessing "atypical symptoms" of depression. Ranges for individual parameters vary but a score of 0 signifies less severity (e.g., no/absent) and incrementally higher scores represent more severe symptoms. Total SIGH-D scores can range from 0 to 90. A higher overall SIGH-D score denotes increased severity of Depression.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c)	6 months	Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.
Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)	6 months	Percent of time with glucose values between 70-180 mg/dl will be calculated from CGM wear in the 6 months after randomization.

Trial Locations

Locations (2)

Boston University; 🇺🇸 Boston, Massachusetts, United States

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States