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临床试验/NCT06978894
NCT06978894招募中不适用

Predicting Psychotic Relapse Using Speech-Based Early Detection

Douglas Mental Health University Institute3 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
3
主要终点
Likelihood of relapse estimated using Speech-NLP Metrics

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Likelihood of relapse estimated using Speech-NLP Metrics

时间窗: Monthly, up to 24 months

This primary outcome will assess the ability of speech-based NLP metrics (coherence, connectedness, and complexity) to predict impending relapses in psychosis. Monthly speech samples will be analyzed to determine if changes in these metrics can distinguish timepoints preceding relapses from those not followed by relapse, with the aim of predicting relapses up to four weeks in advance. The likelihood of relapse is a numerical probabilistic estimate without any units. Outcome definition: Occurrence of relapse (i.e., psychiatric hospitalization, an increase in the level of psychiatric care, or substantial clinical deterioration \>1wk that requires \>25% increase in Defined Daily Dose equivalents of antipsychotics)

Generalization of Speech-Based Relapse Prediction Models Across Languages and Genders

时间窗: Monthly, up to 24 months

This outcome will assess whether the speech-based relapse prediction models are valid and perform equally well across different languages (English and French) and genders (male and female). The study will evaluate how sociodemographic factors such as language and sex impact the predictive accuracy of the models. NLP metrics (coherence, connectedness, complexity) will be correlated with clinical outcomes, and model performance will be compared across linguistic and gender subgroups to ensure generalizability.

次要结局

  • Likelihood of relapse estimated using multi-level speech features(Monthly, up to 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lena Palaniyappan

Director, Centre of Excellence in Youth Mental Health

Douglas Mental Health University Institute

研究点 (3)

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