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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| DexCom, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Gonzalez, PhD | Contact | 646-592-4506 | jeffrey.gonzalez@yu.edu | |
| Keyla Ordonez, BS | Contact | 631-747-9325 | keyla.ordonez@einsteinmed.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Gonzalez, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Recruiting | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27879358 | Background | 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. | |
| 33651537 | Background | 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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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.
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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.
|
| 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. |
|
| 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. |
| 6 months |
| 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. |
| 12 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. | 9 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. | 12 months |
| 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 |
| 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 |
| Albert Einstein College of Medicine | Recruiting | The Bronx | New York | 10461 | United States |
|
| Background | American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). 2013. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
Not provided
Not provided