Scaling Mental Healthcare in COVID-19 With Voice Biomarkers

• ClinicalTrials.gov Identifier: NCT04510519
• Recruitment Status: Not yet recruiting
• First Posted: August 12, 2020
• Last Update Posted: August 13, 2020
• Sponsor: Kintsugi Mindful Wellness, Inc.
• Information provided by (Responsible Party): Kintsugi Mindful Wellness, Inc.

Tracking Information

• First Submitted Date: August 7, 2020
• First Posted Date: August 12, 2020
• Last Update Posted Date: August 13, 2020
• Estimated Study Start Date: September 1, 2020
• Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2020)

• Patient Health Questionnaire (PHQ-9) [ Time Frame: March 30, 2021 ]
  A repeated measures, within-subject design using exploratory techniques will identify the best group session features or combination of features that correlate with or predict change on the PHQ-9.
• Generalized Anxiety Disorder (GAD-7) [ Time Frame: June 20, 2021 ]
  A repeated measures, within-subject design using exploratory techniques will identify the best group session features or combination of features that correlate with or predict change on the GAD-7.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Scaling Mental Healthcare in COVID-19 With Voice Biomarkers
• Official Title: Scaling Mental Healthcare in COVID-19 With Voice Biomarkers: An Observational Study
• Brief Summary: This study aims to advance research on group sessions for mental health. The first-of-its-kind study measuring various features in a group setting, combining rich metadata in creating state-of-the-art machine learning models, and developing workflows for mental health that are both scalable and personalized.

Detailed Description

The anticipated impact of this study is defining voice biomarker features and reward functions for a deep reinforcement learning based system from group interactions that improve depression and anxiety outcomes. The investigators' ability to quantify the real-time impact of human-intervention in scaled group video sessions can be very meaningful for creating best practices in the area where measurement is infrequent.

The investigators' priority is to scale the optimal mix of individuals for group therapy sessions based on reward functions that maximize improvements in depression and anxiety scores. Current group therapy appointments may track little save few who use various group feedback questionnaires (e.g. OQ, GCQ, or GQ). Voice biomarkers can play a key role in the real-time measurement of mental health.

The proposed work is to conduct a feasibility study on creating reward functions that most effectively enable engagement for group sessions as measured by voice biomarkers before, during, and after group video meetings.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: The study population includes men and women over the age of 18 years

Condition

• Major Depressive Disorder
• Generalized Anxiety

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 11, 2020): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2021
• Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Ownership of a personal iPhone (version iOS 12.0 or later) and willingness to install and maintain the Kintsugi app for remote participation throughout the study duration
• Able to understand and comply with instructions in English

Exclusion Criteria:

• Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
• Has a visual or physical motor impairment that could interfere with study tasks
• Is site personnel directly affiliated with this study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04510519
• Other Study ID Numbers: COV-1
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Kintsugi Mindful Wellness, Inc.
• Study Sponsor: Kintsugi Mindful Wellness, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kintsugi Mindful Wellness, Inc.
• Verification Date: August 2020