CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19,533 enrolled
Drug / intervention
Patient Health Questionnaire-9 +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05455905
NCT05455905N/ACompleted

Voice Biomarkers Predictive of Depression and Anxiety: An Observational Study

Kintsugi Mindful Wellness, Inc.·observational·Posted Jul 13, 2022·Updated Sep 15, 2022

In Brief

An observational study evaluating Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and 2 other interventions for Depression, Anxiety and 2 related conditions. Completed, enrolled 19,533 participants across 1 site.

Detailed Summary

The objective of this study is to collect data to improve the sensitivity and specificity of Kintsugi Voice's (formerly KiVATM) predictions on audio files. A web-based audio recording tool will be used to record voice sample and ask participants the PHQ-9 and GAD-7 questions. A voluntary subset of participants will then be assessed by mental health professionals with the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 13, 2022
Enrollment StartSep 14, 2021
Primary CompletionSep 11, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.0 years ago

Interventions

Patient Health Questionnaire-9other

The Patient Health Questionnaire-9 is a nine question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Patient Health Questionnaire-9 is scored from 0 to 27 where higher scores are associated with more severe depression.

Generalized Anxiety Disorder-7other

The Generalized Anxiety Disorder-7 is a seven question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Generalized Anxiety Disorder-7 is scored from 0 to 21 where higher scores are associated with more severe anxiety.

Hamilton Depression Rating Scaleother

The Hamilton Depression Rating Scale is administered by a mental health profession and includes twenty-one questions asking about how the participant has been feeling in the past week. The Hamilton Depression Rating Scale is scored from 0 to 45 where higher scores are associated with more severe depression.

Hamilton Anxiety Rating Scaleother

The Hamilton Anxiety Rating Scale is administered by a mental health profession and includes fourteen questions asking about how the participant has been feeling in the past week. The Hamilton Anxiety Rating Scale is scored from 0 to 56 where higher scores are associated with more severe anxiety.