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Recruiting NCT06978894

Predicting Psychotic Relapse Using Speech-Based Early Detection

Observational Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Psychosis. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Psychotic disorders, including schizophrenia and affective psychosis, are severe mental health conditions marked by recurrent episodes that contribute to long-term disability. Relapses, characterized by the re-emergence of psychotic symptoms after remission, are a critical factor in the progression of these disorders, increasing risks such as suicide, cognitive impairment, and unemployment. This study aims to develop a novel, speech-based digital model to predict relapses in individuals with psychosis. Building on previous research into language abnormalities in schizophrenia, the study will employ a longitudinal design across Early Psychosis Intervention (EPI) clinics in Ontario and Quebec to advance relapse prediction

Detailed description

OBJECTIVES: The primary goal of this study is to develop and validate a speech-based digital model to predict psychotic relapses in individuals with early psychosis. The study specifically aims to:

Test the hypothesis that within-subject changes in speech coherence, connectedness, and complexity, as measured by natural language processing (NLP) tools, will accurately identify imminent relapse, up to four weeks before clinical relapse in individuals receiving care in Early Psychosis Intervention (EPI) programs.

Investigate whether these speech-based relapse prediction models generalize across different languages (English and French) and are equally predictive in both males and females, addressing potential sociodemographic and linguistic influences on model performance.

Explore whether combining acoustic and prosodic features with core NLP-based speech measures improves the model's sensitivity and specificity for relapse prediction.

METHODS:

This study will employ a longitudinal, prospective design involving 250 first-episode psychosis (FEP) patients recruited from three Early Psychosis Intervention (EPI) clinics in Ontario and Quebec. The study aims to develop and evaluate a speech-based relapse prediction model, with a particular focus on generalizing results across different languages (English and French) and genders.

Participant Recruitment and Stratification:

Participants: A total of 250 FEP patients, including both English- and French-speaking individuals, will be enrolled to ensure linguistic diversity. The sample will be stratified by sex to evaluate model performance across genders.

Language groups: Approximately 60% of the participants will be English speakers and 40% French speakers, reflecting the population served by the EPI clinics.

Gender representation: The study aims to ensure that at least 40% of participants are female to assess gender-based differences in model prediction performance.

Baseline Assessments:

At baseline, participants will undergo a comprehensive in-person assessment to collect a detailed profile for each patient. This will include psychiatric symptomatology using the Positive and Negative Syndrome Scale (PANSS), Calgary Depression Scale and the Personal and Social Performance (PSP) scale, and cognitive functioning. Additionally, socioeconomic variables, historical and current medication usage, substance use (e.g., cannabis), and treatment adherence will also be recorded to provide a full clinical and treatment profile for each participant.

Speech Sampling and Data Collection:

Monthly Speech Samples: After the baseline assessment, participants will provide monthly speech samples over the course of 24 months. These speech samples will be collected using web-based prompts that include open-ended tasks, such as picture description or recall narratives, designed to elicit spontaneous speech.

Attrition and Speech Sample Estimates: Given an expected attrition rate of 35-50%, it is estimated that by the end of the study, 840-960 speech samples will be obtained from English-speaking participants and 660-870 speech samples from French-speaking participants.

Speech Analysis:

The collected speech samples will be analyzed using natural language processing (NLP) methods to extract key features associated with psychosis, including coherence (Measured by lexical predictability), Connectedness (Assessed using speech graph analysis) and Complexity (evaluated using the Analytic Thinking Index (ATI)). These NLP-derived speech metrics will be tracked over time to predict imminent psychotic relapses and compared across subgroups to assess the impact of language and gender on the predictive accuracy of the relapse model.

Data Analysis and Generalization:

The primary objective is to determine whether speech-based relapse prediction models generalize across different languages and genders. To achieve this, model performance will be evaluated across subgroups:

Linguistic subgroup analysis will compare the model's performance in English- and French-speaking participants.

Gender-based analysis will assess whether the predictive power of the speech-based model varies between male and female participants.

This analysis will ensure that the final model can be generalized across diverse populations and adapted for use in different clinical settings.

Primary outcome measures

  • Likelihood of relapse estimated using Speech-NLP Metrics [Time frame: Monthly, up to 24 months]
  • Generalization of Speech-Based Relapse Prediction Models Across Languages and Genders [Time frame: Monthly, up to 24 months]
Secondary outcome measures (1)
  • Likelihood of relapse estimated using multi-level speech features [Time frame: Monthly, up to 24 months]

Eligibility criteria

Inclusion criteria

  • Age must be 16 years and older
  • Diagnosis must meet DSM-5 criteria for psychotic disorders, including schizophrenia, schizoaffective disorder, or related conditions
  • Fluency in English or French
  • Must be currently receiving treatment through an EPI program

Exclusion criteria

  • Severe comorbid speech or language disorders (e.g., aphasia)
  • Primary diagnosis of non-psychotic disorders
  • Inability to provide consent or complete assessments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Canada · 3 centers
  • Robarts Research Institute — London
  • Douglas Mental Health University Institute — Montreal
  • Vitam — Québec

Publications

  • Zaher F, Diallo M, Achim AM, Joober R, Roy MA, Demers MF, Subramanian P, Lavigne KM, Lepage M, Gonzalez D, Zeljkovic I, Davis K, Mackinley M, Sabesan P, Lal S, Voppel A, Palaniyappan L. Speech markers to predict and prevent recurrent episodes of psychosis: A narrative overview and emerging opportunities. Schizophr Res. 2024 Apr;266:205-215. doi: 10.1016/j.schres.2024.02.036. Epub 2024 Feb 29. PMID 38428118

Identifiers

NCT: NCT06978894 · 2024-979

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗