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

Diabetes Clinical Trial

— UP-CBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734313
• Other study ID #: 2022-14517
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Albert Einstein College of Medicine
• Contact: Jeffrey Gonzalez, PhD
• Phone: 646-592-4506
• Email: jeffrey.gonzalez[@]yu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	DexCom, Inc., Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

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* Note: There are 69 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin A1c (HbA1c)	Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.	9 months
Other	Hemoglobin A1c (HbA1c)	Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.	12 months
Other	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.	9 months
Other	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.	12 months
Other	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.	9 months
Other	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.	12 months
Primary	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
Primary	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	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
Secondary	Hemoglobin A1c (HbA1c)	Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.	6 months