Speech-based Assessment of Relapse Risk in People With Psychosis
NCT07397975, Recruiting, Philipp Homan
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Speech-based Assessment of Relapse Risk in People With Psychosis | ClinicalTrials.gov |
| NCT number | NCT07397975 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 360 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Philipp Homan | ClinicalTrials.gov |
| Conditions | Psychotic Disorder | ClinicalTrials.gov |
| 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. | ClinicalTrials.gov |
| First posted | 2026-02-09 | ClinicalTrials.gov |
| Last updated | 2026-02-09 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Feasibility: User adherence | 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. | ClinicalTrials.gov |
| Primary | Feasibility: Transcription quality | 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 | ClinicalTrials.gov |
| Primary | Feasibility: Usability of recordings | 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 | ClinicalTrials.gov |
| Primary | Overall system usability | 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. | ClinicalTrials.gov |
| Primary | Performance of the monitoring system for relapse prediction | 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 | ClinicalTrials.gov |
| Secondary | Provider-perceived usability and usefulness | 6 months and 12 months | 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 | ClinicalTrials.gov |
| Secondary | Relapse Outcome 1 | 6 months and 12 months | Relapse rate, defined as the proportion of participants experiencing at least one relapse (rehospitalization) during the study period. | ClinicalTrials.gov |
| Secondary | Relapse Outcome 2 | From enrollment to the end of the study at 12 months | 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. | ClinicalTrials.gov |
| Secondary | Relapse Outcome 3 | From enrollment to the end of the study at 12 months | 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. | ClinicalTrials.gov |
| Secondary | Relapse Outcome 4 | From enrollment to the end of the study at 12 months | Predictive performance of HITL relapse risk estimates will be evaluated using the area under the curve (AUC), with exploratory assessment of prediction thresholds. | ClinicalTrials.gov |
| Secondary | Relapse Outcome 5 | From enrollment to the end of the study at 12 months | 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. | ClinicalTrials.gov |
| Secondary | Recordings Outcome 1 | From enrollment to the end of the study at 12 months | Number of recordings per participant across all sessions. | ClinicalTrials.gov |
| Secondary | Recordings Outcome 2 | From enrollment to the end of the study at 12 months | Interpretation of question: has the user interpreted the question correctly? Yes or no. Per recording. | ClinicalTrials.gov |
| Secondary | Recordings Outcome 3 | From enrollment to the end of the study at 12 months | Audibility of audio: is the audio (at least partially) audible? Yes or no. Per recording. | ClinicalTrials.gov |
| Secondary | Recordings Outcome 4 | From enrollment to the end of the study at 12 months | Comprehensibility of audio: is the audio (at least partially) comprehensible? Yes or no. Per recording | ClinicalTrials.gov |
| Secondary | Speech-based features | From enrollment to the end of study at 12 months. | Exploratory comparison analysis of speech-based features extracted using tools such as Prosogram or openSMILE. | ClinicalTrials.gov |
| Secondary | Text-based features Outcome 1 | From enrollment to the end of the study at 12 months. | 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. | ClinicalTrials.gov |
| Secondary | Text-based features Outcome 2 | From enrollment to the end of the study at 12 months | WordNet will be used to analyze correctness of responses where appropriate (fluency task, story recall task, adapted Stroop task). | ClinicalTrials.gov |
| Secondary | Neuroimaging-based features Outcome 1 | 6 months and 12 months | Exploratory comparison analysis of features extracted from structural magnetic resonance imaging (sMRI) data. | ClinicalTrials.gov |
| Secondary | Neuroimaging-based features Outcome 2 | 6 months and 12 months | Exploratory comparison analysis of features extracted from functional magnetic resonance imaging (fMRI) data. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42665342 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)