Scaling Mental Healthcare in COVID-19 With Voice Biomarkers

NCT04510519 | Completed

• 1 other identifier: COV-1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Generalized Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kintsugi Mindful Wellness, Inc.: lead

Study Sites (1)

Kintsugi Mindful Wellness, Inc.

Berkeley, California, 94705, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 12, 2020
• Study Start: January 12, 2022
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

US (1)