Speech-based Assessment of Relapse Risk in People With Psychosis

Официальное название

A Prospective Multicenter Study for Relapse Risk Assessment Through Language Analysis in Individuals With Psychosis

Обзор

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.

Подробное описание

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.

Apart from this Fast Diagnostic Loop, where a clinical decision will be made, an exploratory component will be incorporated to identify and validate new speech markers associated with relapse. This New Marker Discovery Loop will involve the search of additional speech features associated with relapse beyond the standard markers. The goal is to discover novel speech markers that may improve our understanding of relapse mechanisms and potentially serve as predictive or diagnostic tools for future clinical use.

For the 1-year follow-up period, participants will attend a total of three study visits. These visits will occur at the following time points: Visit 0: Baseline visit, Visit 1: 6 months post-baseline (±10 days), and Visit 2: 12 months post-baseline (±10 days). During these visits, participants from both groups will undergo assessments aiming to evaluate the usability and trustworthiness of the procedure and to assess various functional and quality-of-life outcomes.

Вмешательства

• Другое 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.
  The intervention is a weekly online assessment of speech, to detect subtle characteristics of psychotic speech. These recordings are made through a speech data collection tool: a smartphone app with implemented tasks for the collection of behavioral response data (speech and self-report). Data is then transferred to a safe repository (TSD) to be analysed by an AI-based speech data analysis algorithm: a backend system will run the predictor code to calculate automatic relapse risk scores.

Первичные конечные точки

• Feasibility: User adherence [Срок оценки: From enrollment to the end of the study at 12 months]
• Feasibility: Transcription quality [Срок оценки: From enrollment to the end of the study at 12 months]
• Feasibility: Usability of recordings [Срок оценки: From enrollment to the end of the study at 12 months]
• Overall system usability [Срок оценки: 6 months and 12 months]
• Performance of the monitoring system for relapse prediction [Срок оценки: From enrollment to the end of the study at 12 months]

Вторичные конечные точки (12)

• Provider-perceived usability and usefulness [Срок оценки: 6 months and 12 months]
• Relapse Outcome 1 [Срок оценки: 6 months and 12 months]
• Relapse Outcome 2 [Срок оценки: From enrollment to the end of the study at 12 months]
• Relapse Outcome 3 [Срок оценки: From enrollment to the end of the study at 12 months]
• Relapse Outcome 4 [Срок оценки: From enrollment to the end of the study at 12 months]
• Relapse Outcome 5 [Срок оценки: From enrollment to the end of the study at 12 months]
• Recordings Outcome 1 [Срок оценки: From enrollment to the end of the study at 12 months]
• Recordings Outcome 2 [Срок оценки: From enrollment to the end of the study at 12 months]
• Recordings Outcome 3 [Срок оценки: From enrollment to the end of the study at 12 months]
• Recordings Outcome 4 [Срок оценки: From enrollment to the end of the study at 12 months]
• Speech-based features [Срок оценки: From enrollment to the end of study at 12 months.]
• Text-based features Outcome 1 [Срок оценки: From enrollment to the end of the study at 12 months.]

Критерии участия

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 Exclusion Criteria:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 2 центра

• University Hospital Geneva and University of Geneva — Geneva
• Psychiatric University Hospital Zurich and University of Zurich — Zurich

Чехия · 1 центр

• National Institute of Mental Health — Klecany

Ирландия · 1 центр

• Newcastle Hospital and RCSI University of Medicine and Health Sciences — Greystones

Нидерланды · 1 центр

• University Medical Center Groningen — Groningen

Норвегия · 1 центр

• The Arctic University of Norway — Tromsø

Turkey (Türkiye) · 1 центр

• Dokuz Eylul University — Izmir

Идентификаторы

NCT: NCT07397975 · TRUSTING-WP4-Obs_EK2025-01177

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗