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Completed

NCT Number: NCT05601050

Linguistic Predictors of Outcomes in Psychosis

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

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

There is no intervention

Other

There is no intervention

Primary outcomes

  1. Speech features from the Winterlight Speech Assessment

    Time frame: 6 months

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

Secondary outcomes

  1. Brief Psychiatric Rating Scale (BPRS)

    Time frame: 6 months

    18 item, range = 1, not observed - 7, very severe; higher scores resulting in worse outcome.

  2. Hamilton Rating Scale for Depression

    Time frame: 6 months

    24 item, range = 0, absent - 4, severe; higher scores resulting in worse outcome.

  3. Young Mania Rating Scale

    Time frame: 6 months

    11 item, range = 0, absent - 8, severe; higher scores resulting in worse outcome.

  4. Scale for the Assessment of Negative Symptoms

    Time frame: 6 months

    22 item, range= 0, absent - 5, severe; higher scores resulting in worse outcome.

  5. Scale for the Assessment of Thought Language and Communication

    Time frame: 6 month

    20 item, range= 0, absent - 3, severe; higher scores resulting in worse outcome.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Winterlight Labs

Registry information

Acronym: LPOP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2022
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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