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CompletedNCT04510519Updated Sep 30, 2022

Scaling Mental Healthcare in COVID-19 With Voice Biomarkers

An observational study in Major Depressive Disorder and Generalized Anxiety, sponsored by Kintsugi Mindful Wellness, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-30.

Sponsored by Kintsugi Mindful Wellness, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Major Depressive Disorder
  • Generalized Anxiety
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 20 is below the median of 150 across 653 observational studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Kintsugi Mindful Wellness, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population includes men and women over the age of 18 years

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: March 30, 2021

  2. 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.

    Time frame: June 20, 2021

07

Study locations

1 site
  • Kintsugi Mindful Wellness, Inc.
    Berkeley, California 94705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04510519
Lead sponsor
Kintsugi Mindful Wellness, Inc.
Responsible party
Sponsor
First posted
Aug 12, 2020
Start date
Jan 12, 2022
Primary completion
Mar 2, 2022
Completion
Mar 2, 2022
Last update
Sep 30, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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