Speech-based Assessment of Relapse Risk in People With Psychosis

NCT07397975 | Recruiting

• 1 other identifier: TRUSTING-WP4-Obs_EK2025-01177
• Study Type: observational
• Target: 360
• Locations: 6 countries
• Sites: 7

Brief Summary

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.

Conditions

Psychotic Disorder

Outcome Measures

Primary Outcomes (5)

• Feasibility: User adherence

  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.

  From enrollment to the end of the study at 12 months

• Feasibility: Transcription quality

  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

  From enrollment to the end of the study at 12 months

• Feasibility: Usability of recordings

  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

  From enrollment to the end of the study at 12 months

• Overall system usability

  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.

  6 months and 12 months

• Performance of the monitoring system for relapse prediction

  Assessed by the Area Under the Receiver Operating Characteristic Curve (AUC). Thresholds for relapse prediction will be explored as part of the analysis

  From enrollment to the end of the study at 12 months

Secondary Outcomes (23)

• 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

Study Arms (2)

At risk of relapse

Individuals at risk of psychotic relapse

Other: 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.

Healthy controls

Healthy participants will be used as controls

Other: 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.

Interventions

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

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.

At risk of relapse; Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants at risk of relapse will be recruited from clinical settings while in a stable phase of partial or full remission. Depending on the site, eligible individuals may be either inpatients nearing discharge or outpatients under ongoing care. If the treating clinician considers the patient's mental state sufficiently stable, the study information and consent process may be initiated during inpatient care, prior to discharge. For outpatients, participants may be contacted by phone, or the study can be presented during routine outpatient or day clinic visits. Healthy participants will be recruited through community outreach, advertisements, and volunteer registries from universities and hospitals. healthy participants will be selected to match individuals with psychosis based on key characteristics such as age and sex in each site.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Severe comorbid speech disorders (aphasia or severe stuttering) that prevent adequate speech recording.

Sponsors & Collaborators

• Philipp Homan: lead

Study Sites (7)

National Institute of Mental Health

Klecany, 250 67, Czechia

NOT YET RECRUITING

Newcastle Hospital and RCSI University of Medicine and Health Sciences

Greystones, Wicklow, A63 CD30, Ireland

NOT YET RECRUITING

University Medical Center Groningen

Groningen, 9713, Netherlands

NOT YET RECRUITING

The Arctic University of Norway

Tromsø, 9037, Norway

ACTIVE NOT RECRUITING

University Hospital Geneva and University of Geneva

Geneva, Chêne-Bourg, 1225, Switzerland

NOT YET RECRUITING

Psychiatric University Hospital Zurich and University of Zurich

Zurich, 8032, Switzerland

RECRUITING

Dokuz Eylul University

Izmir, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Philipp Homan, Prof. Dr. med. univ. PhD

CONTACT

+41 58 384 33 65; philipp.homan@bli.uzh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. univ. Philipp Homan, PhD

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 9, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); IE (1); CZ (1); TU (1); NO (1); CH (2)