Psychotic DisorderTRUSTING-WP4NCT07397975
Speech-based Assessment of Relapse Risk in People With Psychosis
An observational study of Psychotic Disorder, run by Philipp Homan at 7 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorder
- What is being tested?
- 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.
- How many people
- 360 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 29 Jan 2026to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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.
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Switzerland2 sites, 2 recruiting
- Not yet recruiting
University Hospital Geneva and University of Geneva
Geneva, Chêne-Bourg, 1225
Stefan Kayser, Prof, +41 22 30 55 104, Stefan.Kaiser@hug.ch
- Recruiting
Psychiatric University Hospital Zurich and University of Zurich
Zurich, 8032
Giacomo Cecere, MD, +41 58 384 21 11, giacomo.cecere@pukzh.ch
Czechia1 site, 1 recruiting
- Not yet recruiting
National Institute of Mental Health
Klecany, 250 67
Filip Spaniel, PhD, +420 777 444 490, filip.spaniel@nudz.cz
Ireland1 site, 1 recruiting
- Not yet recruiting
Newcastle Hospital and RCSI University of Medicine and Health Sciences
Greystones, Wicklow, A63 CD30
John Paul Lyne, MD, 00353-1-2819001, johnlyne@rcsi.ie
Netherlands1 site, 1 recruiting
- Not yet recruiting
University Medical Center Groningen
Groningen, 9713
Iris Sommer, PhD, +31 503 616 402, i.e.c.sommer@umcg.nl
Norway1 site
- Active, not recruiting
The Arctic University of Norway
Tromsø, 9037
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
Dokuz Eylul University
Izmir
Emre Bora, MD, 90 232 41 24151, emre.bora@deu.edu.tr
About this study
Official title: A Prospective Multicenter Study for Relapse Risk Assessment Through Language Analysis in Individuals With Psychosis
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.
Read the detailed description
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.
- Conditions
- Psychotic Disorder
- Being tested
- 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.
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| At risk of relapse | Individuals at risk of psychotic relapse Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: From enrollment to the end of the study at 12 months
Secondary outcomes (23)
Provider-perceived usability and usefulness
Provider-perceived usability and usefulness of the app will be assessed using the mHealth App Usability Questionnaire (MAUQ - Provider version). Scores will be reported by domain and overall
Measured: 6 months and 12 months
Relapse Outcome 1
Relapse rate, defined as the proportion of participants experiencing at least one relapse (rehospitalization) during the study period.
Measured: 6 months and 12 months
Relapse Outcome 2
Human-in-the-loop (HITL) relapse risk estimates and relapse incidence: HITL risk scores (range 0-1) will be categorized into low (0-0.2), medium (>0.2-0.6), and high (>0.6) risk levels. Descriptive analyses will assess the proportion of relapses within each category.
Measured: From enrollment to the end of the study at 12 months
Relapse Outcome 3
Clinical decision support system (CDSS) relapse risk estimates and relapse incidence: CDSS risk scores (range 0-1) will be categorized into low, medium, and high risk using the same thresholds. Descriptive analyses will assess relapse proportions per category.
Measured: From enrollment to the end of the study at 12 months
Relapse Outcome 4
Predictive performance of HITL relapse risk estimates will be evaluated using the area under the curve (AUC), with exploratory assessment of prediction thresholds.
Measured: From enrollment to the end of the study at 12 months
Relapse Outcome 5
Concordance between CDSS and HITL relapse risk estimates will be assessed by evaluating the level of agreement between algorithm-based and clinician-based risk scores.
Measured: From enrollment to the end of the study at 12 months
Recordings Outcome 1
Number of recordings per participant across all sessions.
Measured: From enrollment to the end of the study at 12 months
Recordings Outcome 2
Interpretation of question: has the user interpreted the question correctly? Yes or no. Per recording.
Measured: From enrollment to the end of the study at 12 months
Recordings Outcome 3
Audibility of audio: is the audio (at least partially) audible? Yes or no. Per recording.
Measured: From enrollment to the end of the study at 12 months
Recordings Outcome 4
Comprehensibility of audio: is the audio (at least partially) comprehensible? Yes or no. Per recording
Measured: From enrollment to the end of the study at 12 months
Speech-based features
Exploratory comparison analysis of speech-based features extracted using tools such as Prosogram or openSMILE.
Measured: From enrollment to the end of study at 12 months.
Text-based features Outcome 1
In addition, robust text-based features like speech rate and pause rate will be derived using common Python libraries for Natural Language Processing (NLP) like NLTK and spaCy.
Measured: From enrollment to the end of the study at 12 months.
Text-based features Outcome 2
WordNet will be used to analyze correctness of responses where appropriate (fluency task, story recall task, adapted Stroop task).
Measured: From enrollment to the end of the study at 12 months
Neuroimaging-based features Outcome 1
Exploratory comparison analysis of features extracted from structural magnetic resonance imaging (sMRI) data.
Measured: 6 months and 12 months
Neuroimaging-based features Outcome 2
Exploratory comparison analysis of features extracted from functional magnetic resonance imaging (fMRI) data.
Measured: 6 months and 12 months
Neuroimaging-based features Outcome 3
Exploratory comparison analysis of features extracted from Diffusion Tensor Imaging (DTI) data.
Measured: 6 months and 12 months
Social and occupational function of participants Outcome 1
Quality of life assessed with Quality of Life Scale (QoL). Assessed only in participants at risk of relapse
Measured: Baseline, 6 months and 12 months
Social and occupational function of participants Outcome 2
Global Assessment of Functioning Scale (GAF): measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100. Assessed only in participants at risk of relapse
Measured: 6 months and 12 months
Social and occupational function of participants Outcome 3
Social and Occupational Functioning Assessment Scale (SOFAS): a global rating of current social and occupational functioning with scores ranging from 0 to 100. It differs from GAF by focusing on social and occupational functioning independent of the overall severity of the individual's psychological symptoms. Assessed only in participants at risk of relapse
Measured: 6 months and 12 months
Social and occupational function of participants Outcome 4
Number of psychiatric admissions. Assessed only in participants at risk of relapse
Measured: 6 months and 12 months
Social and occupational function of participants Outcome 5
Duration (in weeks) of psychiatric admissions. Assessed only in participants at risk of relapse
Measured: 6 months and 12 months
Social and occupational function of participants Outcome 6
Rates of self-harm (including suicide, suicide attempts and aggressive incidents) assessed with the Social Dysfunction \& Aggression Scale (SDAS). Assessed only in participants at risk of relapse
Measured: 6 months and 12 months
Social and occupational function of participants Outcome 7
Positive and Negative Syndrome Scale (PANSS): measure the prevalence of positive and negative syndromes in schizophrenia. Scores will be reported by dimension (positive, negative, and general psychopathology) and overall. Assessed only in participants at risk of relapse
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start29 Jan 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipp Homan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philipp Homan, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397975
- Sponsor's protocol ID
- TRUSTING-WP4-Obs_EK2025-01177
- Acronym
- TRUSTING-WP4
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huppi RM, Bautista L, Cecere G, Omlor W, Just SA, Koops S, Hussain M, Tedeschi E, Benke-Bruderer S, Bora E, Lyne J, Kaiser S, Sprungli-Toffel E, Kirschner M, Mikalsen KO, Bongo LA, Van der Eycken E, Spaniel F, Elvevag B, Sommer IE, Hinzen W, Homan P. Speech-based relapse prediction in psychosis using explainable AI: Protocol for the international multicentre observational TRUSTING study. BMJ Open. 2026 Aug 28;16(8):e114585. doi: 10.1136/bmjopen-2025-114585.
PubMed 42665342
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study for Relapse Risk Assessment Through Language Analysis in Individuals With Psychosis
- ClinicalTrials.gov ID
- NCT07397975
- Acronym / sponsor ID
- TRUSTING-WP4 / TRUSTING-WP4-Obs_EK2025-01177
- Conditions
- Psychotic Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Philipp HomanUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At risk of 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.Individuals at risk of psychotic relapse |
| Healthy 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.Healthy participants will be used as controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | At risk of relapse, Healthy controls |
Primary outcome
Feasibility: User adherence
Time frame: From enrollment to the end of the study at 12 months
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.
Feasibility: Transcription quality
Time frame: From enrollment to the end of the study at 12 months
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
Feasibility: Usability of recordings
Time frame: From enrollment to the end of the study at 12 months
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
Overall system usability
Time frame: 6 months and 12 months
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.
Performance of the monitoring system for relapse prediction
Time frame: From enrollment to the end of the study at 12 months
Assessed by the Area Under the Receiver Operating Characteristic Curve (AUC). Thresholds for relapse prediction will be explored as part of the analysis
23 secondary outcomes
Provider-perceived usability and usefulness
Time frame: 6 months and 12 months
Relapse Outcome 1
Time frame: 6 months and 12 months
Relapse Outcome 2
Time frame: From enrollment to the end of the study at 12 months
Relapse Outcome 3
Time frame: From enrollment to the end of the study at 12 months
Relapse Outcome 4
Time frame: From enrollment to the end of the study at 12 months
Relapse Outcome 5
Time frame: From enrollment to the end of the study at 12 months
Recordings Outcome 1
Time frame: From enrollment to the end of the study at 12 months
Recordings Outcome 2
Time frame: From enrollment to the end of the study at 12 months
Recordings Outcome 3
Time frame: From enrollment to the end of the study at 12 months
Recordings Outcome 4
Time frame: From enrollment to the end of the study at 12 months
Speech-based features
Time frame: From enrollment to the end of study at 12 months.
Text-based features Outcome 1
Time frame: From enrollment to the end of the study at 12 months.
Text-based features Outcome 2
Time frame: From enrollment to the end of the study at 12 months
Neuroimaging-based features Outcome 1
Time frame: 6 months and 12 months
Neuroimaging-based features Outcome 2
Time frame: 6 months and 12 months
Neuroimaging-based features Outcome 3
Time frame: 6 months and 12 months
Social and occupational function of participants Outcome 1
Time frame: Baseline, 6 months and 12 months
Social and occupational function of participants Outcome 2
Time frame: 6 months and 12 months
Social and occupational function of participants Outcome 3
Time frame: 6 months and 12 months
Social and occupational function of participants Outcome 4
Time frame: 6 months and 12 months
Social and occupational function of participants Outcome 5
Time frame: 6 months and 12 months
Social and occupational function of participants Outcome 6
Time frame: 6 months and 12 months
Social and occupational function of participants Outcome 7
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 42665342Huppi RM, Bautista L, Cecere G, Omlor W, Just SA, Koops S, Hussain M, Tedeschi E, Benke-Bruderer S, Bora E, Lyne J, Kaiser S, Sprungli-Toffel E, Kirschner M, Mikalsen KO, Bongo LA, Van der Eycken E, Spaniel F, Elvevag B, Sommer IE, Hinzen W, Homan P. Speech-based relapse prediction in psychosis using explainable AI: Protocol for the international multicentre observational TRUSTING study. BMJ Open. 2026 Aug 28;16(8):e114585. doi: 10.1136/bmjopen-2025-114585.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorder, run by Philipp Homan at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland, Czechia, Ireland, Netherlands, Norway and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Homan, Prof. Dr. med. univ. PhD (+41 58 384 33 65, philipp.homan@bli.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: User adherence (time frame: From enrollment to the end of the study at 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07397975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.