NCT07789808

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 12, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

voice biomarkersspeech biomarkersdigital phenotypingmental healthdepressionanxietyPHQ-9GAD-7voice journaling

Outcome Measures

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.

    Through study completion, up to 24 months

Secondary Outcomes (1)

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

    Through study completion, up to 24 months

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kintsugi Mindful Wellness, Inc.

Berkeley, California, 94707, United States

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersPersonal Satisfaction

Study Officials

  • Grace Chang

    Kintsugi Mindful Wellness, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 27, 2026

Study Start

October 1, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations