Linguistic Predictors of Outcomes in Psychosis

NCT ID: NCT05601050

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-04

Study Completion Date

2023-03-01

Brief Summary

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Longitudinal observational study of the relationship between speech patterns and clinical symptoms in schizophrenia spectrum disorders.

Detailed Description

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The accurate prediction and tracking of clinical and functional outcomes in young people with schizophrenia-spectrum disorders is critical for delivering appropriate interventions and for understanding the brain mechanisms behind psychosis. Language is an optimal avenue for tracking psychosis processes because language is readily produced and captured, has well-established disruptions in psychosis, and known relationship to brain circuits. Using computers to automate detection of language features has the further advantage of being objective, quantitative, and adaptable into an efficient and cost-effective tool. The investigators propose to use automated linguistic analyses in young people early in the course of schizophrenia spectrum disorders to measure language features including fluency (speech rate), complexity (proportion of unique words), prosody (changes in tone during speech), and semantic coherence (how sequencing of words conform to expected patterns).

The investigators will test whether these features meaningfully reflect clinical symptoms, cognition, and functioning, and whether they help predict how psychosis symptoms change over time.

Conditions

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Schizophrenia and Related Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PSD (Psychosis spectrum disorder) group

Current DSM-V-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, unspecified psychotic disorder, or brief psychotic disorder, or bipolar 1 disorder with psychotic features or major depressive disorder with psychotic features using the Structured Clinical Interview for Axis I DSM-V Disorders (SCID-I/P).

There is no intervention

Intervention Type OTHER

There is no intervention

Interventions

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There is no intervention

There is no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Speaks English with conversational proficiency
* Current DSM-V-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, unspecified psychotic disorder, or brief psychotic disorder or bipolar 1 disorder with psychotic features or major depressive disorder with psychotic features using the Structured Clinical Interview for Axis I DSM-V Disorders (SCID-I/P).
* Current significant positive or disorganized symptoms of psychosis (DSM 5 Criterion A) including rating at or above any of the following on the BPRS:
* Grandiosity (Severe - 6)
* Suspiciousness (Moderately Severe - 5)
* Hallucinations (Moderately Severe - 5)
* Unusual thought content (Moderate - 4)
* Bizarre Behavior (Moderate - 4)
* Disorientation (Moderate - 4)
* Conceptual Disorganization (Moderate - 4)
* Early phase of psychotic illness as defined by less than 2 years elapsed since reaching threshold for psychotic disorder
* Age 15 to 40 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 psychosis symptoms frequently onset 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.

Exclusion Criteria

* Participants with substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, or shared psychotic disorder will not be included.
* Patient currently under the influence of alcohol or drugs.
* 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
* Significant risk of suicidal or homicidal behavior;
* Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Winterlight Labs

INDUSTRY

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Sunny Tang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunny X Tang, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health, The Feinstein Institutes of Medical Research

Locations

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Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-0460

Identifier Type: -

Identifier Source: org_study_id

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