Kintsugi Voice Device SCID-5-CT Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
研究概览
简要总结
A prospective, single arm, non-randomized, pilot 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-CT) for up to 500 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.
详细描述
Depression affects approximately 30% of people every year in the United States. Detecting mental health conditions early can help patients get the help they need sooner. Machine Learning Devices may be one way to help clinicians identify patients with mental health conditions. Clinicians may then be able to help patients receive the right level of care earlier. Many researchers are working to increase mental health screening. Machine Learning can detect subtle patterns like changes in the voice when someone is experiencing mental health conditions. Changes in the voice associated with a mental health condition are voice biomarkers.
The purpose of this study is to find correlations between voice and how people sound with clinical diagnoses. Kintsugi Mindful Wellness, Inc. has developed a tool, the Kintsugi Voice Device, that assesses mental health and conditions like depression by studying the voice. The study's goal is to test the ability of the Device to identify depressive symptoms.
Up to 500 people will take part in this research. Subject recruitment is expected to take up to 1 year. Completion of the study activities may take about 2 hours but subjects may stay enrolled for up to 2 weeks based on clinician availability for scheduling the Structured Clinical Interview for DSM-5 (SCID) interview.
Study participants will:
- Answer brief self-reported eligibility confirmation questionnaires. These answers help the researchers understand participant health history.
- Schedule a teleconference with a licensed Clinical Psychologist to evaluate their mental health over Zoom. The Clinical Psychologist will guide participants through the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT). The Clinical Psychologist will be licensed in the participant's state of residence. This assessment will be video and audio recorded for quality assurance purposes. If participants do not agree to being videotaped and/or audio recorded, they will be unable to join the study. The SCID-5-CT assessment is for research purposes only and is not intended for treatment purposes. The results of the SCID will not be shared with participants.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >22 at the time of informed consent
- •Access to a laptop, smartphone, tablet, or other device with a functioning microphone and access to the Internet
- •Stated willingness to be video and audio recorded as part of the study
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Fluency in English
- •Availability for the duration of the study
- •Resides in the United States at the time of consent and during completion of study
- •Contributes to the approximately 50/50 depressed/healthy study population distribution
排除标准
- •Any impairment that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., visual impairment, motor impairment, and/or hearing impairment)
- •Any lifetime history of neurological disease that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., Central Nervous System disorders, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and/or Parkinson's Disease)
- •Any lifetime history of Stroke, cognitive defect (E.g., dementia or Alzheimer's disease), and/or Traumatic Brain Injury
- •Presence of voice disorders that impacts their ability to speak (E.g., acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia)
- •Past or active heavy smokers (an average of >20 cigarettes per day)
- •Subjects who have previously participated in any Kintsugi-sponsored study.
研究组 & 干预措施
Depressed
All study participants will undergo the same study procedures. All individuals will complete brief online assessments about their emotional and physical wellbeing, provide audio recorded voice responses to prompts, and complete the SCID-5-CT with a clinician licensed in their state of residence while being audio and video recorded for quality assurance purposes.
干预措施: Kintsugi Voice Device (Device)
结局指标
主要结局
Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
时间窗: Day 1
Determine the performance of the KV Device in discriminating the presence of a current significant depressive episode using the SCID-5-CT diagnosis of current MDD and/or MDE using sensitivity and specificity.
次要结局
- Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT(Day 1)
- Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9(Day 1)
- PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5(Day 1)