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NCT05554042 · ClinicalTrials.gov registry record
Kintsugi Voice Device Study
A clinical trial of Depression, Anxiety, sponsored by Kintsugi Mindful Wellness.
- Completed
- Registry status
- 132
- Enrollment target
- 1
- Study location
NCT05554042: Completed study of Depression, Anxiety, sponsored by Kintsugi Mindful Wellness.
NCT05554042 is a study of Depression, Anxiety that has completed, run by Kintsugi Mindful Wellness. The registered enrollment target is 132 participants, below the 422-participant average among 40 other Depression, Anxiety trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05554042, a study of Depression, Anxiety, has completed, sponsored by Kintsugi Mindful Wellness.
- COMPLETED
- Registry status
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID) with a trained psychiatrist. This study seeks to evaluate the ability of the Device to aid clinical assessment for depression and anxiety by comparing its output with the established diagnostic standard consisting of a diagnosis made by a specialist clinician based on DSM-5 criteria. The order of the assessments will be randomized. Audio captured during the SCID interview will be inputted into a machine learning model to determine the diagnostic accuracy of the Kintsugi Voice Device.
Primary Outcome
Discriminates the presence of a significant depressive episode using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Kintsugi Voice Device
Study Locations (1)
California
- Kintsugi Mindful Wellness, Inc. - Berkeley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2022-09-23 |
| Est. Completion | 2023-07-05 |
What the finished NCT05554042 record still lists
NCT05554042 is an observational study that tracks outcomes without assigning an intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 422-participant average among 40 other Depression, Anxiety trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Depression, Anxiety appearing as the primary indexed condition, and to 1 intervention - of which Kintsugi Voice Device is the first listed.
NCT05554042 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05554042 about?
NCT05554042 is a clinical study titled "Kintsugi Voice Device Study". The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Intervie...
What is the current status of trial NCT05554042?
This trial is currently completed. The enrollment target is 132 participants. The study started on 2022-09-23. Estimated completion is 2023-07-05.
What conditions does trial NCT05554042 study?
This clinical trial studies the following conditions: Depression, Anxiety.
What interventions are being tested in trial NCT05554042?
The interventions under investigation include: Kintsugi Voice Device (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05554042?
This trial is sponsored by Kintsugi Mindful Wellness, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05554042 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05554042's enrollment target sits among peer trials
132 23rd of 40 higher than 18 of 40 other Depression, Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression, Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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