A Prospective Multicenter Study for Relapse Risk Assessment Through Language Analysis in Individuals With Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 7
- 主要终点
- Feasibility: User adherence
研究概览
简要总结
This observational, multinational study assesses the feasibility of speech and self-report data collection across six languages for Artificial Intelligence (AI)-driven relapse risk estimation in psychosis. Over 12 months, patients at risk of relapse and healthy controls will provide weekly speech recordings and self-report data for automated analysis. Risk scores will be stored but not shared with treating clinicians. Independent clinical evaluations ensure data quality and validation. The study lays the foundation for future Clinical Decision Support System (CDSS) research and explores novel speech markers for relapse prediction while minimizing participant burden.
详细描述
This project follows a prospective, exploratory, observational design with a non-randomized, two-arm structure, including a group of individuals with psychosis at risk of relapse and a healthy control group. As a multicenter, international research project, it will assess the usability and feasibility of speech data collection across 6 different languages (English, German, French, Dutch, Czech and Turkish) and healthcare systems, ensuring its applicability in diverse clinical environments.
Speech and self-report data will be collected weekly for a year using a finalized smartphone application, ensuring consistency and feasibility in real-world clinical settings. The recordings will be securely transferred to an external platform for AI-based analysis, preventing any direct impact on clinical decision-making and maintaining the study's observational nature.
To ensure data integrity and reliability, a Human-in-the-Loop (HITL) quality control process is implemented after each speech recording session:
Initial Data Review: a designated reviewer (HITL1) checks the audio quality and accuracy of automated transcripts stored securely in the Trusted Secure Database (TSD) system in Norway. They correct transcription errors and flag anomalies such as poor audio quality to maintain data accuracy for analysis.
Risk Assessment and Decision Suggestion: a second reviewer (HITL2) evaluates the data by: (i) assessing speech characteristics relevant to relapse risk based on raw response data and performance scores (e.g., story recall accuracy); (ii) providing an independent relapse risk estimate, without access to the automated AI-generated risk assessment, (iii) classify the participant as belonging to either the psychosis or healthy control group, and (iv) suggesting a clinical decision, which is recorded for research purposes but not shared with the treating clinician.
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
- 是
入选标准
- •Healthy participants Inclusion Criteria:
- •Between 18 and 65 years old.
- •Subjects must be able to provide informed consent (IC).
- •Participants must have provided signed informed consent prior to enrollment.
- •Participants should not take prescription drugs regularly.
- •Native or equivalent fluency in speaking and understanding one of the following languages: English, German, Dutch, French, Czech or Turkish.
- •Ability to have access to a smartphone and be capable of using a mobile app for speech-based data collection.
- •Must be able to comply with the study schedule and procedures.
- •Healthy participants
排除标准
- •Any history of major diseases (e.g., cardiovascular, neurological, metabolic, renal, hepatic, respiratory or speech disorders).
- •Recreational drug use or psychiatric disorders due to use of alcohol.
- •Depression, anxiety, or other psychiatric disorders.
- •Family history of depression, anxiety, or other psychiatric disorders.
- •Individuals who are not able or willing to understand the purpose and details of the study.
- •Individuals with psychosis Inclusion Criteria:
- •Between 18 and 65 years old.
- •Diagnoses include psychotic disorders (schizophrenia, schizoaffective disorder, schizophreniform disorder, acute psychosis, bipolar disorder with psychotic symptoms, psychosis not otherwise specified).
- •First visit must be during remission phase (baseline measurement).
- •Current positive symptoms rated 3 (mild) or lower on all of these Brief Psychiatric Symptom Scale (BPRS) items: hallucinatory behavior, unusual thought content, conceptual disorganization.
- •Must be able to comply with the study schedule and procedures.
- •Subjects must be able to provide IC.
- •Participants must have provided signed informed consent prior to enrollment.
- •Native or equivalent fluency in speaking and understanding one of the following languages: English, German, Dutch, French, Czech or Turkish.
- •Ability to have access to a smartphone and be capable of using a mobile app for speech-based data collection.
- •Individuals with psychosis Exclusion Criteria:
- •Severe comorbid speech disorders (aphasia or severe stuttering) that prevent adequate speech recording.
- •Individuals who are not able or willing to understand the purpose and details of the investigation.
- •Citizens with psychiatric or somatic comorbidity, drug- or alcohol abuse will be allowed to participate, so that the sample will reflect the general population of citizens with psychosis and the study's endpoints will be generalizable.
研究组 & 干预措施
At risk of relapse
Individuals at risk of psychotic relapse
干预措施: Weekly online speech assessments via a smartphone app collect speech and self-report data. Recordings are securely transferred and analyzed by an AI-based backend to calculate relapse risk scores. (Other)
Healthy controls
Healthy participants will be used as controls
干预措施: Weekly online speech assessments via a smartphone app collect speech and self-report data. Recordings are securely transferred and analyzed by an AI-based backend to calculate relapse risk scores. (Other)
结局指标
主要结局
Feasibility: User adherence
时间窗: From enrollment to the end of the study at 12 months
Proportion of users adhering to their allocated tasks. Task completion is automatically assessed for each user. A user is regarded as adherent, if they complete at least 33% of their tasks across all sessions.
Feasibility: Transcription quality
时间窗: From enrollment to the end of the study at 12 months
Proportion of users for which high quality transcripts are produced. Transcription quality is measured by the Word Error Rate (WER) between Automated Speech Recognition (ASR) and human corrected transcripts. A user with an overall WER of at most 35% is regarded as having high quality transcripts
Feasibility: Usability of recordings
时间窗: From enrollment to the end of the study at 12 months
Proportion of recordings that can be used by the AI algorithm. Usability of each record is assessed by HITL reviewers based on the three questions (i) has the user interpreted the question correctly, and (ii) is the audio (at least partially) audible and (iii) comprehensible. The three questions must both be answered with yes for the recording to be usable
Overall system usability
时间窗: 6 months and 12 months
Proportion of users rating the app as usable. Usability is evaluated using the System Usability Scale (SUS), providing a standardized usability score (range 0-100) based on a 10-item questionnaire. We regard a score of at least 70 as usable.
Performance of the monitoring system for relapse prediction
时间窗: From enrollment to the end of the study at 12 months
Assessed by the Area Under the Receiver Operating Characteristic Curve (AUC). Thresholds for relapse prediction will be explored as part of the analysis
次要结局
- Provider-perceived usability and usefulness(6 months and 12 months)
- Relapse Outcome 1(6 months and 12 months)
- Relapse Outcome 2(From enrollment to the end of the study at 12 months)
- Relapse Outcome 3(From enrollment to the end of the study at 12 months)
- Relapse Outcome 4(From enrollment to the end of the study at 12 months)
- Relapse Outcome 5(From enrollment to the end of the study at 12 months)
- Recordings Outcome 1(From enrollment to the end of the study at 12 months)
- Recordings Outcome 2(From enrollment to the end of the study at 12 months)
- Recordings Outcome 3(From enrollment to the end of the study at 12 months)
- Recordings Outcome 4(From enrollment to the end of the study at 12 months)
- Speech-based features(From enrollment to the end of study at 12 months.)
- Text-based features Outcome 1(From enrollment to the end of the study at 12 months.)
- Text-based features Outcome 2(From enrollment to the end of the study at 12 months)
- Neuroimaging-based features Outcome 1(6 months and 12 months)
- Neuroimaging-based features Outcome 2(6 months and 12 months)
- Neuroimaging-based features Outcome 3(6 months and 12 months)
- Social and occupational function of participants Outcome 1(Baseline, 6 months and 12 months)
- Social and occupational function of participants Outcome 2(6 months and 12 months)
- Social and occupational function of participants Outcome 3(6 months and 12 months)
- Social and occupational function of participants Outcome 4(6 months and 12 months)
- Social and occupational function of participants Outcome 5(6 months and 12 months)
- Social and occupational function of participants Outcome 6(6 months and 12 months)
- Social and occupational function of participants Outcome 7(6 months and 12 months)
研究者
Philipp Homan
Prof. Dr. med. univ. Philipp Homan, PhD
University of Zurich