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

NCT05734313 | Recruiting DMC FDA Device

• 1 other identifier: 2022-14517
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes; Type 1 Diabetes

Keywords

Diabetes; Type 1 Diabetes; Depression; Anxiety; Diabetes Distress; Diabetes Management; Diabetes Self-Care

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline

• 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.

  Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline

Secondary Outcomes (2)

• Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)

  6 months

• Hemoglobin A1c (HbA1c)

  6 months

Other Outcomes (6)

• Hemoglobin A1c (HbA1c)

  9 months

• Hemoglobin A1c (HbA1c)

  12 months

• Depressive symptom severity

  9 months

Study Arms (2)

Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring

EXPERIMENTAL

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); Device: Continuous Glucose Monitoring (CGM)

Continuous Glucose Monitoring (CGM) Only

ACTIVE COMPARATOR

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)

Interventions

Unified protocol for cognitive behavioral therapy (UP-CBT) 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.

Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring

Continuous Glucose Monitoring (CGM) 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; Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetes (T1D) duration ≥ 6 months
• years old
• English- or Spanish-speaking
• Anxiety or depressive mood disorder as per structured diagnostic interview.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Juvenile Diabetes Research Foundation: collaborator
• DexCom, Inc.: collaborator

Study Sites (2)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

RECRUITING

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MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Jeffrey Gonzalez, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Gonzalez, PhD

CONTACT

646-592-4506; jeffrey.gonzalez@yu.edu

Keyla Ordonez, BS

CONTACT

631-747-9325; keyla.ordonez@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 17, 2023
• Study Start: March 31, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)