Major Depressive DisorderNCT04510519
Scaling Mental Healthcare in COVID-19 With Voice Biomarkers
An observational study of Major Depressive Disorder and Generalized Anxiety, run by Kintsugi Mindful Wellness, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Generalized Anxiety
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 2 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes men and women over the age of 18 years
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kintsugi Mindful Wellness, Inc.
Berkeley, California, 94705
About this study
Official title: Scaling Mental Healthcare in COVID-19 With Voice Biomarkers: An Observational Study
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.
- Conditions
- Major Depressive Disorder, Generalized Anxiety
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: June 20, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start12 Jan 2022
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintsugi Mindful Wellness, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510519
- Sponsor's protocol ID
- COV-1
- Status last verified
- Sep 2022
- First submitted
- 7 Aug 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Mental Healthcare in COVID-19 With Voice Biomarkers: An Observational Study
- ClinicalTrials.gov ID
- NCT04510519
- Acronym / sponsor ID
- COV-1
- Conditions
- Major Depressive Disorder, Generalized Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kintsugi Mindful Wellness, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes men and women over the age of 18 years
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Generalized Anxiety, run by Kintsugi Mindful Wellness, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: March 30, 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.