A Prospective Multicenter Study for Relapse Risk Assessment Through Language Analysis in Individuals With Psychosis
Trial ID: NCT07397975
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-01-29
Completion date: 2029-01-31
Sponsor: Philipp Homan
Conditions: Psychotic Disorder
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.
Locations: National Institute of Mental Health; Newcastle Hospital and RCSI University of Medicine and Health Sciences; University Medical Center Groningen; The Arctic University of Norway; University Hospital Geneva and University of Geneva; Psychiatric University Hospital Zurich and University of Zurich; Dokuz Eylul University
Countries: Czechia; Ireland; Netherlands; Norway; Switzerland; Switzerland; Turkey (Türkiye)
Enrollment: 360
Age range: 18 Years - 65 Years
Sex: ALL

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.

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.

Outcomes:
Feasibility: User adherence; Feasibility: Transcription quality; Feasibility: Usability of recordings; Overall system usability; Performance of the monitoring system for relapse prediction