Clinical trial NCT06374056: Kintsugi Voice Device Pilot Study
Official title: Kintsugi Voice Device SCID-5-CT Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Depression
Depression Moderate
Depression Severe
Depression Mild
Keywords: Depression
Lead sponsor: Kintsugi Mindful Wellness, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sonar Strategies
name: Vituity Psychiatry
First posted: 2024-04-18
Enrollment: 500
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll up to 500 English speaking subjects \>22 years old. Only subjects who meet all eligibility criteria and sign the informed consent will be enrolled. Participants who do not meet the criteria required for participation will not be presented with the opportunity to participate. Screen failures will not be considered a part of this research study.

Brief summary: 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.

Detailed description: 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.

On the day of the teleconference with a licensed Clinical Psychologist participants will:

* Complete three brief self-assessment surveys asking about their electronic device, mental health and quality of life: the Patient Health Questionnaire-9 (PHQ-), Generalized Anxiety Disorder-7 (GAD-7), and the World Health Organization Quality of Life (WHOQOL). These assessments will take approximately 15 minutes in total.
* Participants will provide an audio recording in response to 3 prompts of their choosing. The audio recording will be inputted to the Kintsugi Voice Device to receive a prediction of current signs of depression. The Kintsugi Voice Device Prediction is for research purposes only and will not be shared with participants.
* Complete the SCID-5-CT while being videotaped and audio recorded with a licensed psychologist or psychiatrist and participant responses will be recorded. The SCID will allow the clinician to assess participants' current mental status.

This study is intended for research purposes and is not intended for treatment and/or diagnostic purposes. The risks to this study are minimal and/or temporary and short lived. The study team has implemented procedures to minimize them wherever possible. There is always the potential for breach of confidentiality. To minimize this risk, all entries are encrypted. Researchers de-identify personal information using IDs. Researchers will store all data in a secure, password protected database and Google Cloud Platform bucket. Participation may bring up emotional content which could temporarily impact mood. To minimize this risk, everyone will be emailed a list of mental health resources.

There is no cost to subjects for participation. There may be no direct benefit from participation. Indirect benefits may include reduction in stress, learning more about mental health. Knowledge gained from the study could potentially benefit patients in the future.

Only personal and health information directly related to the research is collected, for safety purposes, or as required to provide participants with payment, including:

* Name
* Age
* Address
* Phone Number
* Email Address
* Demographic information (e.g. race, gender, and ethnicity)
* English Proficiency
* Emergency Contact Information
* Audio recording of the SCID-5-CT
* Video recording of the SCID-5CT
* Audio recordings in response to prompts
* Brief Medical History and Medications
* Results of the SCID-5-CT
* Device Information
* PHQ-9 Responses
* GAD-7 Responses
* Behavioral and Quality of Life Survey Responses

Identifiable data will be kept for 7 years. De-identified data will be kept indefinitely.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
timeFrame: Day 1
Secondary outcomes:
measure: PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5
timeFrame: Day 1
measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT
timeFrame: Day 1
measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9
timeFrame: Day 1
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Kintsugi Mindful Wellness Inc.
state: California
Study officials:
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