Speech-based test to estimate relapse risk in psychosis

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

This project will try using weekly smartphone speech recordings and short self-reports to see if an automated system can predict relapse risk in people with psychosis.

Quick facts

• Study type: Observational
• Enrollment: 360 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Zurich (Academic / other)
• Locations: 7 sites (Klecany and 6 other locations)
• Trial ID: NCT07397975 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, multicenter project that collects weekly speech recordings and brief self-reports from people with psychosis at risk of relapse and from healthy controls over 12 months. Data are collected in six languages (English, German, French, Dutch, Czech, Turkish) through a smartphone app and securely transferred for AI-driven analysis. Human-in-the-loop reviewers check audio and transcripts and provide quality control while automated algorithms generate relapse risk scores that are stored but not shared with treating clinicians. The work aims to test feasibility, usability, and preliminary predictive markers across diverse healthcare settings without changing patient care during the study.

Who should consider this trial

Good fit: Adults 18–65 with a diagnosed psychotic disorder who are currently stable but considered at risk of relapse, fluent in English, German, Dutch, French, Czech or Turkish, able to use a smartphone, and able to give informed consent are ideal candidates.

Not a fit: Patients without smartphone access, with severe active symptoms that prevent reliable speech reporting, major neurological or speech disorders, significant substance use, or inability to complete weekly recordings are unlikely to benefit from this observational protocol.

Why it matters

Potential benefit: If successful, this approach could provide an early-warning tool that flags rising relapse risk so clinicians and patients can consider timely support or treatment adjustments.

How similar studies have performed: Prior pilot studies and small cohorts have shown promising speech-based markers for psychosis relapse, but large, multilingual prospective validations remain limited.

Eligibility criteria

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.

Where this trial is running

Klecany and 6 other locations

• National Institute of Mental Health — Klecany, Czechia (Not_yet_recruiting)
• Newcastle Hospital and RCSI University of Medicine and Health Sciences — Greystones, Wicklow, Ireland (Not_yet_recruiting)
• University Medical Center Groningen — Groningen, Netherlands (Not_yet_recruiting)
• The Arctic University of Norway — Tromsø, Norway (Active_not_recruiting)
• University Hospital Geneva and University of Geneva — Geneva, Chêne-Bourg, Switzerland (Not_yet_recruiting)
• Psychiatric University Hospital Zurich and University of Zurich — Zurich, Switzerland (Recruiting)
• Dokuz Eylul University — Izmir, Turkey (Türkiye) (Not_yet_recruiting)

Study contacts

• Study coordinator: Philipp Homan, Prof. Dr. med. univ. PhD

Conditions Psychotic Disorder