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OpenTrials
Completed

NCT Number: NCT04510519

Scaling Mental Healthcare in COVID-19 With Voice Biomarkers

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.

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Key information

Conditions

Major Depressive Disorder Anxiety Disorders Depressive Disorder Depressive Disorder, Major Generalized Anxiety Generalized Anxiety Disorder Mental Disorders Mood Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kintsugi Mindful Wellness, Inc.

Berkeley, California, 94705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kintsugi Mindful Wellness, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2020
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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