Scaling Mental Healthcare in COVID-19 With Voice Biomarkers

Major Depressive Disorder Clinical Trial

Official title:

Scaling Mental Healthcare in COVID-19 With Voice Biomarkers: An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510519
• Other study ID #: COV-1
• Status: Completed
• Start date: January 12, 2022
• Est. completion date: March 2, 2022

Study information

• Verified date: September 2022
• Source: Kintsugi Mindful Wellness, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Generalized Anxiety
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	Kintsugi Mindful Wellness, Inc.	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
Kintsugi Mindful Wellness, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9)	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.	March 30, 2021
Primary	Generalized Anxiety Disorder (GAD-7)	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.	June 20, 2021