LPOP: Linguistic Predictors of Outcomes in Psychosis

Sponsor
Northwell Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05601050
Collaborator
Winterlight Labs (Industry)
77
1
23.9
3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: There is no intervention

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
77 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Linguistic Predictors of Outcomes in Psychosis
Actual Study Start Date :
Mar 4, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
There is no intervention

Outcome Measures

Primary Outcome Measures

  1. Speech features from the Winterlight Speech Assessment [6 months]

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

Secondary Outcome Measures

  1. Brief Psychiatric Rating Scale (BPRS) [6 months]

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

  2. Hamilton Rating Scale for Depression [6 months]

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

  3. Young Mania Rating Scale [6 months]

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

  4. Scale for the Assessment of Negative Symptoms [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 [6 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zucker Hillside Hospital Glen Oaks New York United States 11004

Sponsors and Collaborators

  • Northwell Health
  • Winterlight Labs

Investigators

  • Principal Investigator: Sunny X Tang, MD, Northwell Health, The Feinstein Institutes of Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunny Tang, Assistant Professor, Northwell Health
ClinicalTrials.gov Identifier:
NCT05601050
Other Study ID Numbers:
  • 20-0460
First Posted:
Nov 1, 2022
Last Update Posted:
Nov 1, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sunny Tang, Assistant Professor, Northwell Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2022