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

Not Applicable

Recruiting

• Conditions: Diabetes; Type 1 Diabetes

• 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

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