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Scaling Mental Healthcare in COVID-19 With Voice Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510519
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 13, 2020
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
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