Ascertaining Diagnosis Classification With Elicited Speech

NCT05601063 | Completed

• 1 other identifier: 20-0468
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

Cross-sectional observational study of the relationship between speech patterns and psychiatric symptoms and disorders.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depressive Disorder; Anxiety Disorders; Personality Disorders; Attention Deficit Hyperactivity Disorder

Keywords

Psychiatry; language; natural language processing; digital health

Outcome Measures

Primary Outcomes (1)

• Speech features from the Winterlight Speech Assessment

  Acoustic and linguistic measures of speech computed based on performance on the Winterlight Speech Assessment

  Baseline

Secondary Outcomes (5)

• Brief Symptom Inventory

  Baseline

• Patient Health Questionnaire - 9

  Baseline

• Generalized Anxiety Disorder - 7

  Baseline

• Prodromal Questionnaire - Brief

  Baseline

• Scale for the Assessment of Thought Language and Communication

  Baseline

Study Arms (2)

Psychiatric patient group

Current diagnosis in the medical chart of any of the following. The patient may be in partial but not full remission. Comorbidity among these disorders and other unlisted disorders is expected and allowable. * Schizophrenia-spectrum disorder - schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or unspecified psychotic disorder * Bipolar spectrum disorder - bipolar I or II disorder, cyclothymia, unspecified or other specified bipolar disorder * (Unipolar) Depressive disorder - major depressive disorder, dysthymia, unspecified and other specified depressive disorder * Anxiety disorder - obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, post-traumatic stress disorder * Personality disorder - borderline personality disorder * Attention-Deficit Hyperactivity Disorder

Behavioral: Winterlight Speech Assessment

Healthy controls

Healthy comparison subjects with no known psychiatric diagnosis

Behavioral: Winterlight Speech Assessment

Interventions

Winterlight Speech Assessment BEHAVIORAL

Digital assessment of speech and language abilities

Healthy controls; Psychiatric patient group

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients whose treatment team believes they would be appropriate for a research study will be approached by research staff and the research project will be explained to them in detail. Inpatients will be approached during their admission and after initial stabilization. Outpatients will be approached before or after their scheduled appointments. Educational seminars regarding this study may be held to inform clinicians and staff of our goals and protocol. Potential participants will be made aware that declining participation will not affect their care. Informed consent will be obtained from all those interested in participating in the study.

You may qualify if:

• Speaks with conversational proficiency with conversational proficiency
• Current diagnosis in the medical chart of any of the following. The patient may be in partial but not full remission. Comorbidity among these disorders and other unlisted disorders is expected and allowable.
• Schizophrenia-spectrum disorder - schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or unspecified psychotic disorder
• Bipolar spectrum disorder - bipolar I or II disorder, cyclothymia, unspecified or other specified bipolar disorder
• (Unipolar) Depressive disorder - major depressive disorder, dysthymia, unspecified and other specified depressive disorder
• Anxiety disorder - obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, post-traumatic stress disorder
• Personality disorder - borderline personality disorder
• Attention-Deficit Hyperactivity Disorder
• Healthy comparison subjects
• Age 14 - 50 years
• Has capacity and willing to sign informed consent; if minor, parent is willing to give consent and child is willing to give assent.
• Screening will not include a pregnancy test. Pregnant women will not be screened out of the study because the study procedures are of very low risk overall, and pregnancy does not place the participant or the fetus at any significant risk.
• Minors will be included in the study because diagnostic ambiguity is prevalent before the age of 18 and this patient group is particularly in need of accurate prognosis and treatment. Therefore, it is of vital importance that the conclusions of the study be applicable to minors and that they be included among the participants.

You may not qualify if:

• Participants with substance-induced disorders or disorders secondary to a general medical condition will not be included as underlying brain changes may be different from "primary" psychiatric disorders.
• Disorders affecting speech or language, such as aphasia, intellectual disability (IQ\<70), or language disorder, or movement disorders affecting speech like tardive dyskinesia, or physical impairments causing significant distortions to speech
• Serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain and/or language, including but not limited to: neurodegenerative disorders, traumatic brain injury with active symptoms, autism spectrum disorder, encephalitis, epilepsy
• Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent

Sponsors & Collaborators

• Northwell Health: lead
• Winterlight Labs: collaborator

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depressive Disorder; Anxiety Disorders; Personality Disorders; Attention Deficit Disorder with Hyperactivity; Language

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Communication; Behavior

Study Officials

• Sunny X Tang, MD

  Northwell Health, The Feinstein Institutes of Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 1, 2022
• Study Start: October 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)