Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression
NCT ID: NCT05734313
Last Updated: 2025-10-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
94 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-03-31
Study Completion Date
2027-12-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Diabetes
Type 1 Diabetes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Trained clinical interviewers blind to treatment assignment will administer structured clinical interviews to assess primary outcomes of anxiety and depression symptom severity at each assessment. Time in Range will be calculated from CGM data by an analyst who is blind to assignment. Hemoglobin A1c (HbA1c) will be collected via mailed kits at each assessment and analyzed by a lab blind to assignment. Anxiety and Depression severity data will be measured longitudinally throughout the trial, at baseline, immediately post-intervention, and at 9- and 12-months post-randomization by independent assessors blind to the assignment.
Study Groups
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Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring
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.
Group Type
EXPERIMENTAL
Unified protocol for cognitive behavioral therapy (UP-CBT)
Intervention Type
BEHAVIORAL
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.
Continuous Glucose Monitoring (CGM)
Intervention Type
DEVICE
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.
Continuous Glucose Monitoring (CGM) Only
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.
Group Type
ACTIVE_COMPARATOR
Continuous Glucose Monitoring (CGM)
Intervention Type
DEVICE
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.
Interventions
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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.
Intervention Type
BEHAVIORAL
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.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes (T1D) duration ≥ 6 months
* 18-64 years old
* English- or Spanish-speaking
* Anxiety or depressive mood disorder as per structured diagnostic interview.
* 18-64 years old
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
64 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
Sponsor Role
collaborator
DexCom, Inc.
INDUSTRY
Sponsor Role
collaborator
Albert Einstein College of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jeffrey Gonzalez, PhD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Boston University
Boston, Massachusetts, United States
Site Status
RECRUITING
Albert Einstein College of Medicine
The Bronx, New York, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Young-Hyman D, de Groot M, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Psychosocial Care for People With Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Dec;39(12):2126-2140. doi: 10.2337/dc16-2053. No abstract available.
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Gonzalez JS, Hood KK, Esbitt SA, Mukherji S, Kane NS, Jacobson A. Psychiatric and Psychosocial Issues Among Individuals Living With Diabetes. In: Cowie CC, Casagrande SS, Menke A, Cissell MA, Eberhardt MS, Meigs JB, Gregg EW, Knowler WC, Barrett-Connor E, Becker DJ, Brancati FL, Boyko EJ, Herman WH, Howard BV, Narayan KMV, Rewers M, Fradkin JE, editors. Diabetes in America. 3rd edition. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases (US); 2018 Aug. CHAPTER 33. Available from http://www.ncbi.nlm.nih.gov/books/NBK567974/
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-14517
Identifier Type: -
Identifier Source: org_study_id
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