Linguistic Predictors of Outcomes in Psychosis

NCT05601050 | Completed

• 1 other identifier: 20-0460
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia and Related Disorders

Keywords

Schizophrenia; speech; language; 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.

  6 months

Secondary Outcomes (5)

• Brief Psychiatric Rating Scale (BPRS)

  6 months

• Hamilton Rating Scale for Depression

  6 months

• Young Mania Rating Scale

  6 months

• Scale for the Assessment of Negative Symptoms

  6 months

• Scale for the Assessment of Thought Language and Communication

  6 month

Study Arms (1)

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).

Other: There is no intervention

Interventions

There is no intervention OTHER

There is no intervention

PSD (Psychosis spectrum disorder) group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients will be recruited from Northwell Health. 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. Potential participants will also be screened for by reviewing newly admitted patients to the inpatient units. 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

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; Speech; Language

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Verbal Behavior; 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: COHORT
• Time Perspective: PROSPECTIVE
• 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: March 4, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)