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

Study Overview
=================
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 young 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 150 young adults (age 18-35) 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.

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

Conditions
-----------------
Diabetes, Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Unified protocol for cognitive behavioral therapy (UP-CBT)
* Device: Continuous Glucose Monitoring (CGM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes (T1D) duration ≥ 6 months 18-35 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two arms in this trial, (1) The Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) Intervention Arm paired with use of continuous glucose monitor (CGM) and (2) CGM only. The active comparison condition of CGM only allows for the evaluation of whether directly targeting emotional disorders with UP-CBT adds value beyond the state-of-the-art approach to glycemic management in Type 1 Diabetes. To the extent that the relationship between emotional disorders and diabetes is bidirectional, a common assumption across research studies in this area, the comparison condition should benefit anxiety and depression outcomes through improved glycemic control and diabetes self-management.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring<br>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. | Behavioral: Unified protocol for cognitive behavioral therapy (UP-CBT)<br>* 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.<br>Device: Continuous Glucose Monitoring (CGM)<br>* 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.<br>|
| Active Comparator: Continuous Glucose Monitoring (CGM) Only<br>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. | Device: Continuous Glucose Monitoring (CGM)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptom severity | 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. | 6 months | 
| Depressive symptom severity | 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. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Type 1 Diabetes, Depression, Anxiety, Young Adult, Diabetes Distress, Diabetes Management, Diabetes Self-Care