跳至主要内容
临床试验/NCT04510519
NCT04510519已完成不适用

Scaling Mental Healthcare in COVID-19 With Voice Biomarkers: An Observational Study

Kintsugi Mindful Wellness, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Generalized Anxiety Disorder (GAD-7)

研究概览

简要总结

This study aims to advance research on group sessions for mental health. The first-of-its-kind study measuring various features in a group setting, combining rich metadata in creating state-of-the-art machine learning models, and developing workflows for mental health that are both scalable and personalized.

详细描述

The anticipated impact of this study is defining voice biomarker features and reward functions for a deep reinforcement learning based system from group interactions that improve depression and anxiety outcomes. The investigators' ability to quantify the real-time impact of human-intervention in scaled group video sessions can be very meaningful for creating best practices in the area where measurement is infrequent.

The investigators' priority is to scale the optimal mix of individuals for group therapy sessions based on reward functions that maximize improvements in depression and anxiety scores. Current group therapy appointments may track little save few who use various group feedback questionnaires (e.g. OQ, GCQ, or GQ). Voice biomarkers can play a key role in the real-time measurement of mental health.

The proposed work is to conduct a feasibility study on creating reward functions that most effectively enable engagement for group sessions as measured by voice biomarkers before, during, and after group video meetings.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ownership of a personal iPhone (version iOS 12.0 or later) and willingness to install and maintain the Kintsugi app for remote participation throughout the study duration
  • Able to understand and comply with instructions in English

排除标准

  • Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
  • Has a visual or physical motor impairment that could interfere with study tasks
  • Is site personnel directly affiliated with this study

结局指标

主要结局

Generalized Anxiety Disorder (GAD-7)

时间窗: June 20, 2021

A repeated measures, within-subject design using exploratory techniques will identify the best group session features or combination of features that correlate with or predict change on the GAD-7.

Patient Health Questionnaire (PHQ-9)

时间窗: March 30, 2021

A repeated measures, within-subject design using exploratory techniques will identify the best group session features or combination of features that correlate with or predict change on the PHQ-9.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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