RECRUITING

Kintsugi Voice Device Pivotal Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A prospective, single arm, non-randomized, pivotal clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-RV) for up to 1000 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks

Official Title

Kintsugi Voice Device SCID-5 Pivotal Study

Quick Facts

Study Start:2025-03-27
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06809907

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Participants with at least one of the following conditions will be excluded:

Contacts and Locations

Study Contact

Dr. Kolby Walker D.O.
CONTACT
(209) 662-5369
Kolby.Walker@vituity.com

Study Locations (Sites)

Kintsugi (Decentralized, Virtual Study)
Berkeley, California, 94707
United States

Collaborators and Investigators

Sponsor: Kintsugi Mindful Wellness, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-27
Study Completion Date2025-11

Study Record Updates

Study Start Date2025-03-27
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Depression
  • Depression Moderate
  • Depression Severe
  • Depression Mild