Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorAlbert Einstein College of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Unified protocol for cognitive behavioral therapy (UP-CBT)
BehavioralUP-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)
DeviceUse 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.
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose MonitoringExperimental treatment 2 interventions
Group B: Continuous Glucose Monitoring (CGM) OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline2
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.
Time frame
Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baselineSecondary outcomes
1
Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)
The percentage of time glucose values were within range (i.e., between 70-180 mg/dL) will be calculated from CGM data during the 6 months after randomization. Results will be summarized by study arm using basic descriptive statistics.
Time frame
6 months2
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) values will be calculated using mailed point-of-care (POC) kits for home collection. Samples will be collected, returned, processed, and shipped for analysis by a central laboratory. HbA1c results will be summarized by study arm using basic descriptive statistics.
Time frame
6 monthsOther outcomes
1
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) values will be calculated using mailed point-of-care (POC) kits for home collection. Samples will be collected, returned, processed, and shipped for analysis by a central laboratory. HbA1c results will be summarized by study arm using basic descriptive statistics.
Time frame
9 months2
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) values will be calculated using mailed point-of-care (POC) kits for home collection. Samples will be collected, returned, processed, and shipped for analysis by a central laboratory. HbA1c results will be summarized by study arm using basic descriptive statistics.
Time frame
12 months3
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.
Time frame
9 months4
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.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Albert Einstein College of Medicine
Lead sponsor
Juvenile Diabetes Research Foundation
Collaborator
DexCom, Inc.
Collaborator
Source ClinicalTrials.gov