Depression / Major Depressive DisorderNCT07789808
Activating Voice Journaling for Mental Health With Voice Biomarkers
An observational study of Depression / Major Depressive Disorder and Anxiety, run by Kintsugi Mindful Wellness, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression / Major Depressive Disorder, Anxiety
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Oct 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None; no participants meeting the inclusion criteria were excluded from the analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Kintsugi Mindful Wellness, Inc.
Berkeley, California, 94707
About this study
Official title: Activating Voice Journaling for Mental Health With Voice Biomarkers: Observational Study
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.
- Conditions
- Depression / Major Depressive Disorder, Anxiety
- Keywords
- voice biomarkers, speech biomarkers, digital phenotyping, mental health, depression, anxiety, PHQ-9, GAD-7, voice journaling
- Medical subject headings
- Depression, Depressive Disorder, Major, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression / 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
- Retrospective
- Enrolment
- 50,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintsugi Mindful Wellness, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grace Chang, Principal investigator, Kintsugi Mindful Wellness, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789808
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Voice Journaling for Mental Health With Voice Biomarkers: Observational Study
- ClinicalTrials.gov ID
- NCT07789808
- Acronym / sponsor ID
- 1
- Conditions
- Depression / Major Depressive Disorder, Anxiety
- Keywords
- voice biomarkers, speech biomarkers, digital phenotyping, mental health, depression, anxiety, PHQ-9, GAD-7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- Kintsugi Mindful Wellness, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 27 Aug 2026 (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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None; no participants meeting the inclusion criteria were excluded from the analysis
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
Association Between Voice Biomarkers and Depressive Symptom Severity (PHQ-9)
Time frame: Through study completion, up to 24 months
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.
1 secondary outcome
Association Between Voice Biomarkers and Anxiety Symptom Severity (GAD-7)
Time frame: Through study completion, up to 24 months
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 27 Aug 2026.
- Individual participant dataSharing planned: 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.
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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.
Grace Chang principal investigator
Kintsugi Mindful Wellness, Inc.
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 Depression / Major Depressive Disorder and 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 3 inclusion and 1 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 27 Aug 2026. 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?
Association Between Voice Biomarkers and Depressive Symptom Severity (PHQ-9) (time frame: Through study completion, up to 24 months). 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 27 Aug 2026.