Clinical trial NCT06792175: Mental Health, Intellectual and Neurodevelopmental Disorder Detection With Artificial Intelligence Models
Official title: Mental Health, Intellectual and Neurodevelopmental Disorder Detection With Artificial Intelligence Models: Testing Speech-Based Machine Learning Algorithms for Clinical Assessment and Risk Stratification in Mental Health Presentations
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Autism Spectrum Disorder
Depression - Major Depressive Disorder
Anxiety, Generalized
Bipolar Disorder (BD)
Attention Deficit Hyperactivity Disorder (ADHD)
Schizophrenia Spectrum &Amp; Other Psychotic Disorders
Post Traumatic Stress Disorder
Obsessive Compulsive Disorder (OCD)
Keywords: Artificial Intelligence
Natural Language Processing
Acoustic Analysis
Acoustic Biomarkers
Clinical Testing
Vocal Biomarkers
Machine Learning
Mental Health
Speech Analysis
Lead sponsor: Psyrin Inc.
Sponsor class: INDUSTRY
Collaborators: name: Allwell Behavioral Health Services
name: The Brookline Center
First posted: 2025-01-24
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The MIND AIM study aims to recruit a diverse and representative sample of individuals seeking mental health assessments in various clinical settings. This broad inclusion criteria ensures high ecological validity, capturing the wide range of presentations and comorbidities commonly encountered in real-world mental health practice.

Brief summary: This study investigates whether AI-driven analysis of speech can accurately predict clinical diagnoses and assess risk for various mental or behavioral health conditions, including attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, bipolar disorder, generalized anxiety disorder, major depressive disorder, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and schizophrenia. We aim to develop tools that can support clinicians in making more accurate and efficient diagnoses.


Eligibility criteria: Inclusion Criteria

1. Participants aged between 16 and 60 years.
2. Individuals currently undergoing or referred for clinical assessment of mental or behavioral health conditions (including but not limited to ADHD, ASD, BPAD, GAD, MDD, OCD, PTSD, SSD)
3. Fluent in English
4. Capable of providing informed consent, or in the case of minors, having a parent or legal guardian who can provide consent on their behalf.
5. Access to a device (smartphone, tablet, or computer) with a microphone and stable internet connectivity, necessary for completing the speech tasks.

Exclusion Criteria

1. Individuals experiencing acute mental health crises or severe symptoms that would preclude meaningful participation in the study, including acute intoxication.
2. Severe cognitive impairment or intellectual disability that would prevent understanding of the study procedures or completion of the speech tasks.
3. Lack of fluency in English.
4. Technical limitations: Inability to access a suitable device or internet connection for completing the speech tasks

Primary outcomes:
measure: Speech Battery ("PSY-10") audio
timeFrame: At initial assessment
measure: Clinical diagnosis
timeFrame: 0 months, 3 months, 6 months
measure: Performance of AI models
timeFrame: 0 months, 3 months, 6 months
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At initial assessment
measure: Mood Disorder Questionnaire (MDQ)
timeFrame: At initial assessment
measure: DSM-5 Level 1 Cross-Cutting Symptom Measure (DSM-XC)
timeFrame: At initial assessment
measure: Reported Distress
timeFrame: After initial assessment
Other outcomes:
Locations:
city: Brookline
country: United States
facility: The Brookline Center
state: Massachusetts
city: Zanesville
country: United States
facility: Allwell Behavioral Health Services
state: Ohio
Study officials:
affiliation: Psyrin Inc.
name: Julianna Olah, B.Sc., M.A., M.Sc., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Psyrin Inc.
name: Atta-ul Raheem R Chaudhry, B.Sc. (Hons.), M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
References: