Clinical trial Recruiting at 1 site Observational Ages 18 to 65

Speech-based test to estimate relapse risk in psychosis

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

Run by University of Zurich · NCT07397975 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 65 Years
SexAll
Enrollment360 (estimated)
SponsorUniversity of Zurich
Academic / other
Locations7 sites (Klecany and 6 other locations)
StatusRecruiting
StartedJanuary 29, 2026
Main results expectedJanuary 31, 2029
Study endsJanuary 31, 2029
Registry record updatedFebruary 9, 2026
Trial IDNCT07397975 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Psychiatric University Hospital Zurich and University of Zurich
    Zurich, Switzerland
    Recruiting
  • 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
Show 1 more location
  • Dokuz Eylul University
    Izmir, Turkey (Türkiye)
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.