ClinicalTrials.gg
CompletedNCT07789808Updated Aug 27, 2026

Activating Voice Journaling for Mental Health With Voice Biomarkers

An observational study in Depression / Major Depressive Disorder and Anxiety, sponsored by Kintsugi Mindful Wellness, Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Kintsugi Mindful Wellness, Inc. · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 3,709 studies in Depression with a site in United States — 578 open to participants now, 717 under way, 30 of them phase 3. Depression · United States.

Enrollment
2nd of 371
50,000 · median 138
Started
2019
with 183 others
Observational
372 of 3,709
55 open now
Registered
3,663rd of 3,709
by date

Among the 3,709 studies in Depression with a site in United States, this one is the 2nd largest by enrollment of the 371 observational ones that give a count, is one of 184 that started in 2019, is one of 372 observational ones, and was the 3,663rd registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

578 of the 3,709 studies in Depression with a site in United States are open now. Recruiting first, the newest first:

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All 578 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: all sexes · healthy volunteers too.

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02

Study summary

This retrospective observational study evaluated the relationship between voice characteristics and self-reported mental health symptoms using longitudinal data collected through the Kintsugi Voice Journaling app. Participants provided voice recordings and completed the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) over time. The study analyzed previously collected data to evaluate whether voice biomarkers could be associated with symptoms of depression and anxiety.

Read the detailed description

This retrospective observational cohort study analyzed previously collected longitudinal data from users of the Kintsugi Voice Journaling app. Participants voluntarily recorded voice samples through the app and completed standardized self-report measures of depression and anxiety, including the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), over a period of several years.

The study population included individuals who used the Kintsugi Voice Journaling app and contributed voice recordings and mental health questionnaire data. No intervention was assigned as part of this study, and no additional data were collected specifically for the research analysis.

The analysis evaluated associations between features derived from participants' voice recordings and self-reported symptoms of depression and anxiety. The study was conducted using previously collected observational data from approximately 50,000 participants.

03

Conditions studied

  • Depression / Major Depressive Disorder
  • Anxiety

Keywords

  • voice biomarkers
  • speech biomarkers
  • digital phenotyping
  • mental health
  • depression
  • anxiety
  • PHQ-9
  • GAD-7
  • voice journaling
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population consisted of users of the Kintsugi Voice Journaling app, a mobile application available globally, who had previously contributed voice recordings and self-reported mental health questionnaire data during routine use of the application. Participants were not recruited at a physical study site; all data were contributed remotely through the app. No participants meeting the inclusion criteria were excluded from the analysis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Use of the Kintsugi Voice Journaling app during the observation period
  • Previously collected voice recording data available from use of the app
  • At least one completed PHQ-9 and/or GAD-7 assessment during the observation period

Exclusion criteria

Exclusion Criteria:

- None; no participants meeting the inclusion criteria were excluded from the analysis

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Kintsugi Voice Journaling App Users

    Individuals who used the Kintsugi Voice Journaling app and contributed voice recordings along with self-reported PHQ-9 and/or GAD-7 assessments during routine use of the application. No intervention was assigned as part of this study; all data were collected previously during routine app use and analyzed retrospectively.

06

What researchers measure

Primary outcomes

  1. Association Between Voice Biomarkers and Depressive Symptom Severity (PHQ-9)

    Association between voice biomarkers and depressive symptom severity as measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depressive symptom severity; each item is scored 0-3 and total scores range from 0 to 27, with higher scores indicating greater (worse) depressive symptom severity.

    Time frame: Through study completion, up to 24 months

Secondary outcomes

  1. Association Between Voice Biomarkers and Anxiety Symptom Severity (GAD-7)

    Association between voice biomarkers and anxiety symptom severity as measured by the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety symptom severity; each item is scored 0-3 and total scores range from 0 to 21, with higher scores indicating greater (worse) anxiety symptom severity.

    Time frame: Through study completion, up to 24 months

07

Study locations

1 site
  • Kintsugi Mindful Wellness, Inc.
    Berkeley, California 94707, United States
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared. The dataset consists of voice recordings, which are inherently identifiable and cannot be reliably de-identified, together with associated self-reported mental health assessments.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2019 to primary completion in Oct 2021, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 27, 2026
StartActual
Oct 1, 2019
Primary completionActual
Oct 1, 2021
CompletionActual
Oct 1, 2021
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07789808
Lead sponsor
Kintsugi Mindful Wellness, Inc.
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Oct 1, 2019
Primary completion
Oct 1, 2021
Completion
Oct 1, 2021
Last update
Aug 27, 2026

Study contacts

Grace Chang
principal investigator · Kintsugi Mindful Wellness, Inc.

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 Aug 2026. You cannot join it, but the record below documents what was studied.

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