Kintsugi Voice Device Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a prospective study of up to 100 subjects, ages >22 years of age. The study is striving for a 50%/50% split of subjects who have depression and/or anxiety and subjects who do not have depression and/or anxiety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05554042
Study type	Observational
Source	Kintsugi Mindful Wellness, Inc.
Contact
Status	Completed
Phase
Start date	September 23, 2022
Completion date	July 5, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04122482` - An Online Course for Improving Knowledge and Access to Mental Health Accommodations in Canadian Enterprises	N/A
Completed	`NCT04085861` - Mental Health in Dancers; an Intervention Study	N/A
Recruiting	`NCT06060210` - Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion	Phase 4
Active, not recruiting	`NCT04588883` - Strengthening Families Living With HIV in Kenya	N/A
Recruiting	`NCT06065787` - NeuroGlove Anxiety and Depression Study	N/A
Active, not recruiting	`NCT04583891` - Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design	N/A
Not yet recruiting	`NCT06162624` - Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons	N/A
Not yet recruiting	`NCT06430853` - Psychobiological Interventions in Pregnancy	N/A
Completed	`NCT02954250` - Mindfulness Based Cognitive Therapy for Depression and Cognitive Inhibition in Suicide	Early Phase 1
Recruiting	`NCT05647499` - Evaluating the Back 2 School Program in a Norwegian Setting: A Multicenter Pilot Study	N/A
Completed	`NCT03980873` - Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach	N/A
Completed	`NCT04422327` - The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome	Phase 1/Phase 2
Completed	`NCT05368155` - Chronic Pelvic Pain and Education Skills Training for Women Veterans	N/A
Completed	`NCT05455905` - Voice Biomarkers Predictive of Depression and Anxiety
Completed	`NCT03272516` - Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients	N/A
Not yet recruiting	`NCT05493865` - Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems	N/A
Not yet recruiting	`NCT06027047` - Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
Not yet recruiting	`NCT05535101` - Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder	N/A
Recruiting	`NCT04418115` - Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option?	N/A
Completed	`NCT04905524` - Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)	N/A