Monitoring Symptoms Severity in Arabic Speaking Schizophrenic Patients Using Mobile Phone Speech Analysis: A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore.
研究概览
简要总结
Brief Summary:
Definition: A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.
Limit: 5000 characters. The purpose of this study is to investigate the relationship between speech features and severity of positive and negative clinical symptoms in Arabic speaking patients with schizophrenia. Individuals will be invited to participate in this study because (1) they have a confirmed clinical diagnosis of schizophrenia; (2) they plan to receive routine clinical care for schizophrenia at one of the four participating sites; (3) they speak Arabic as a first language.
Participants must be between the ages of 18-65 years. Participation will involve seven visits consisting of one baseline visit and six monthly follow-up visits. All participants will continue to receive routine clinical care.
Participation in this research will involve providing speech samples using standardized tasks collected using an electronic device. Additionally, study team members will assess positive and negative symptoms of schizophrenia using validated questionnaires.
详细描述
Speech disorganization is a key feature of schizophrenia. The development of computerized tools to assess speech disorganization is rapidly growing in schizophrenia research. Several early studies showed that changes in speech distinguish schizophrenia patients from healthy controls and assist in differential diagnostics and relapse prevention (1). The Winterlight app can be used for speech collection and assessment and uses speech-based artificial intelligence to identify vocal biomarkers capable of detecting changes in cognitive/clinical symptoms.
Symptom rating scales remain the primary mode of assessing the nature and severity of schizophrenia and the magnitude of any change over time. The Positive and Negative Symptom Scale (PANSS) is a 30-item rating scale that was developed to measure the symptom severity of patients with schizophrenia and assess their dimensions (2). It has been widely used in clinical trials of schizophrenia and is considered as the "gold standard" for the assessment of antipsychotic treatment efficacy.
The goal of this study is to test the hypothesis that quantitative measures derived from speech samples acquired using the Winterlight application will be associated with positive and negative symptom subscores as assessed by the PANSS.
The investigators will use speech-based artificial intelligence methods to identify aspects of voice and language that are related to schizophrenia symptoms in Arabic-speaking patients.
Data collected may be used to evaluate:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 - 65 years
- •Confirmed clinical diagnosis of schizophrenia as per the DSM-5 criteria, at any stage of disease.
- •Planned to receive routine clinical care for schizophrenia in the study site for the next 6 months.
- •Arabic is first language
排除标准
- •Illiterate.
- •Catatonic schizophrenia subtype.
- •Neurological disorder or major health problem.
- •Severe substance use disorder using DSM-5 criteria.
- •Risk to self or others.
- •Patient with any speech disorder or treated/planned to be treated with any medication known to impact speech (e.g. first-generation antipsychotics)
- •Patient or family member is unable to provide consent to participate in the study.
- •Participation in another clinical study.
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore.
时间窗: up to month 6
30-item clinical scale to assess positive and negative symptoms severity in people with schizophrenia.
Speech features derived from the Winterlight Assessment (WLA).
时间窗: up to month 6
Acoustic and linguistic measures of speech acquired using the Winterlight Application
次要结局
- Change in Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore. score measured by the PANSS positive sub-score(Change from baseline to month 6)
- Change in speech features derived from the Winterlight Assessment (WLA).(Change from baseline to month 6)
- Incidence of psychotic relapse(Change from baseline to month 6)