Psychotic DisordersCARENCT05813080
Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
A study testing "pronia.ai" medical device for high risk psychosis prognosis and Treatment-as-usual (TAU) in people with Psychotic Disorders and Prevention, run by Heinrich-Heine University, Duesseldorf at 21 sites in Germany.
Trial summary
Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Psychotic Disorders, Prevention
- What is being tested?
- "pronia.ai" medical device for high risk psychosis prognosis and Treatment-as-usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 21 sitesGermany
- Study dates
- 1 May 2023to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The increased risk of psychosis includes either a symptomatic "ultra high-risk" stage of the Structured Interview for Psychosis-Risk Syndromes or the "Cognitive Disturbances" risk criterion of the Schizophrenia Proneness Instrument - Children and Youth and Adult versions
- ages 16 to 40
- Presence of a written informed consent from the patient and, if applicable, the legal guardian.
Who cannot join
- manifest psychosis according to the definition of the Structured Interview for Psychosis-Risk Syndromes (according to the PRONIA-study) (At least one P-syndrome with a rating of 6 on a daily frequency and for a period of more than one week)
- Lack of capacity to give consent (the patient lacks the capacity to consent if the individual case with regard to the specific treatment measure is excluded. Only when the physician has concrete indications that the patient's capacity to consent may be lacking, he may and must must examine it. Mental disorders (e.g. delirium, dementia, psychosis, mania, depression) or cognitive impairments can have an influence on the capacity to consent. Indications for doubts of a ability to give informed consent exist if the physician has the impression that the patient is not able to understand the provided patient information and is not able to reproduce essential information about the study in his or her own words and is not aware of the possible consequences of the proposed measures
- Severe suicidality during the recruitment phase (CDSS items 8 ≥2)
- A current or past neurological disease of the brain.
- a current or past known somatic disease that potentially affects the structure or function of the brain
- Antipsychotic medication in the indication treatment of psychotic symptoms for >30 days (cumulative number of days) at or above the starting dose for psychosis according to the current German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) S3 guidelines.
Show all 14Show fewer
- an antipsychotic medication in the indication treatment of psychotic symptoms in the 3 months prior to the initial examination (regardless of the duration of use) at or above the starting dose for psychosis according to the current DGPPN S3 guidelines
- An inadequate level of hearing for neurocognitive testing
- a current or past head trauma with unconsciousness (>5 min).
- a current or past alcohol dependence (ICD-10 F10.x)
- A current polytoxicomania (multiple substance dependence) or polytoxicomania in the past 6 months (ICD-10 F19.x)
- Presence of medical reasons that contraindicate performance of an MRI
- Insufficient language skills to understand the indication and the purpose of the intended examinations and interventions
- stationary accommodation against the patient's will
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Germany21 sites
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität Aachen
Aachen, North Rhine-Westphalia, 52074
Rheinhessen Fachklinik Alzey
Alzey, Rhineland-Palatinate, 55232
Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg
Augsburg, Bavaria, 86156
Vivantes Klinikum Am Urban
Berlin, State of Berlin, 10967
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und Präventivmedizin
Bochum, North Rhine-Westphalia, 44791
KJPP LVR-Klinik Bonn
Bonn, North Rhine-Westphalia, 53111
Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie
Bonn, North Rhine-Westphalia, 53127
Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Cologne, North Rhine-Westphalia, 50931
UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Dresden, Saxony, 01307
Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40629
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf {UKE)
Hamburg, Free and Hanseatic City of Hamburg, 20246
Zentrum für Integrative Psychiatrie Kiel
Kiel, Schleswig-Holstein, 24105
ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz
Konstanz, Baden-Wurttemberg, 78479
Zentrum für Integrative Psychiatrie (ZIP) und Fachklinik für Junges Leben (JuLe) Kinder- und Jugendpsychiatrie
Lübeck, Schleswig-Holstein, 23554
Otto-von-Guericke- Universität Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, 68159
Klinikum der Ludwig-Maximilians-Universität München
München, Bavaria, 80336
Institut für Translationale Psychiatrie
Münster, North Rhine-Westphalia, 48149
Klinik für Psychiatrie und Psychotherapie Universität Tübingen
Tübingen, Baden-Wurttemberg, 72076
Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg
Würzburg, Bavaria, 97080
About this study
Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.
Read the detailed description
The study is a Investigator Initiated Trial (IIT)/Other clinical trial of a class 2a medical device according to article 82 medical devices regulation of the European Union.
The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis to actually develop a manifest psychosis.
Patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing.
The AI-supported algorithm "pronia.ai" uses information from both the individual patient data of the specialized routine diagnostics as well as from in-depth clinical diagnostics.
There are two predictions, an individual quantitative assessment of the individual risk of transition to psychosis and the individual prognosis with regard to the level of psychosocial functioning 12 months after inclusion in the study.
The therapists and patients receive a non-binding risk profile from the AI-based recommendation to adjust the treatment intensity from 16 to 24 sessions over a period of six months.
The cognitive behavioral therapy-based manual "Integrated Preventive Psychological Preventive Psychological Intervention (IPPI)" manual is used. In the treatment-as-usual arm (TAU),the patients receive referral back to the previous care system; further treatment (and additional diagnostics, if necessary) is left to the referring primary care providers.
- Conditions
- Psychotic Disorders, Prevention
- Being tested
- "pronia.ai" medical device for high risk psychosis prognosis, Treatment-as-usual (TAU)
- Keywords
- Psychosis-Risk Syndromes, high-risk, Cognitive Disturbances, Artificial Intelligence
- Medical subject headings
- Psychotic Disorders, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"pronia.ai" medical device for high risk psychosis prognosisDevice
In addition to the computer-assisted prognosis of risk for reaching a psychosis, all patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing. Adapted psychological treatment will be offered consisting of 16 to 24 sessions over a period of six months.
Referral back to the previous care system. Further treatment is left to the referring primary care providers.
| Study group | Role | What they receive |
|---|---|---|
| CARE interventional treatment | Experimental | AI-computerassisted prognosis of high risk psychosis profile and adapted study-specific therapy taking place in early-recognition centers. Receives: Device: "pronia.ai" medical device for high risk psychosis prognosis |
| Standard of Care Control arm | Active comparator | Treatment as usual (TAU) patient will receive their usual treatment from their local physicians and therapeutic personnel. Receives: Other: Treatment-as-usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Interview for Psychosis-Risk Syndromes (SIPS)
Presence of psychotic syndrome (POPS) criteria as modified according to the "PRONIA" study, resulting in a score of 0= "no psychosis" or 1= "psychosis"
Measured: 12-month after inclusion
Secondary outcomes (18)
Internalized Stigma of Mental Illness Scale (ISMI)
Consisting of 5-subscales, comprising of 29 items in total using response formats varying from 4-point Likert scales (1='not at all', 4='very often') to 5-point Likert scales (1='never', 5='very often'), assessing self-stigma in terms of alienation, adoption of stereotypes, experiences of discrimination, social withdrawal and stigma resistance.
Measured: 12-month after inclusion
Stigma-Stress-Scale
two dimensions are assessed, 8 items are rated on a 5-point Likert-scale from "strongly disagree" to "totally agree", capturing self-assessed-stigma stress.
Measured: 12-month after inclusion
Self-Identification of Mental Illness Scale (SELF-I)
5-point Likert-scale ranging from 1 = "not true at all" to 5 = " is completely true", capturing the degree of self-identification with mental illnesses.
Measured: 12-month after inclusion
Coming-Out with Mental Illness Scale (COMIS)
consisting of two subscales with 7 and 14 items, each with 7-step Likert-scale ranging from 1 = "do not agree at all" to 7 = " totally agree", capturing a potential change of strategies for dealing with mental illness.
Measured: 12-month after inclusion
Secrecy and disclosure-related distress - scale
7-point single-item-scale ranging from 1 = " not at all" to 7 = "very much", measuring the degree of subjective stress.
Measured: 12-month after inclusion
Psychosis own health-concern single score
5-point Likert-scale ranging from 1 = "not at all" to 5 = "strong", capturing the degree of self-concern in terms of getting a psychosis one day.
Measured: 12-month after inclusion
Numeracy Scale
A single score from 0 to 100% indicating the patient self-estimated amount of belief in risk for developing psychosis within the next 12 months.
Measured: 12-month after inclusion
Coping (Ten-Flex)
Patient self-estimation of likelihood for developing psychosis given on a visual analogue scale (VAS) indicating "I will not develop psychosis in the next 12 months" on the left side of the scale up to "I will definitely develop psychosis in the next 12 months" on the right side of the scale.
Measured: 12-month after inclusion
Risk Perception Scale
A score from 1 =no risk" to 7 = "absolutely certain" indicating the risk for developing psychosis.
Measured: 12-month after inclusion
Risk Recall Scale
A score from 1 = "much lower" to 5 "much higher" indicating the risk for developing psychosis compared to a healthy peer.
Measured: 12-month after inclusion
Health-related quality of life (EQ-5D)
patient questionnaire consisting of two sub-scores. a) score from 0-10 whereas a higher score indicates greater impairment; b) score from 0-100 whereas a higher score indicates better current health status to measure the quality of Life.
Measured: 12-month after inclusion
Brief Multidimensional Life Satisfaction Scale (BMLSS)
Score from 0-126, a higher score indicates a higher amount of satisfaction.
Measured: 12-month after inclusion
Client Sociodemographic and Service Receipt Inventory (CSSRI-EU)
Changes in service use are measured with a semi-structured interview to assess social and demographic data, accommodation data, detailed information regarding treatment, professional visits and social and health service utilization for estimating healthcare costs. Additionally, the CSSRI systematically records the use of psychiatric, medical, psycho-social and rehabilitative health services (direct costs) and productivity losses (indirect costs) and therefore completely covers the costs of the disease from an economic perspective.
Measured: 12-month after inclusion
Patient Satisfaction Questionnaire (ZUF-8)
8 Items with a total score of 8-32, ranging from 4 = "very satisfied" to 1="fairly satisfied" whereas a higher score indicates higher patient satisfaction.
Measured: 12-month after inclusion
Social and occupational assessment scale SOFAS
Scores from 0-100, a higher score indicates better social functioning.
Measured: 12-month after inclusion
Global Functioning Social Scale (GF:S)
Scores from 1-10, a higher score indicates better global functioning
Measured: 12-month after inclusion
Global Functioning Role Scale (GF:R)
Scores from 1-10, a higher score indicates better functioning
Measured: 12-month after inclusion
Secrecy-Symptoms Scale
Five questions (either yes or no) asking who the patient has told about the risk for developing psychosis
Measured: 12-month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 May 2023
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
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 DisordersStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis to actually develop a manifest psychosis.
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Meisenzahl-Lechner, Prof., Principal investigator, Klinik und Poliklinik für Psychiatrie und Psychotherapie LVR-Klinikum Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813080
- Sponsor's protocol ID
- HeinrichHeine
- Acronym
- CARE
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bommhardt T, Peschl J, Schultze-Lutter F, Koutsouleris N, Meisenzahl E, Koberlein-Neu J; CARE Study Group. Enhancing early detection and treatment of psychosis in Germany: a protocol for the health economic evaluation of an artificial intelligence-guided complex intervention. BMJ Open. 2025 Jun 18;15(6):e103151. doi: 10.1136/bmjopen-2025-103151.
PubMed 40533222
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
- ClinicalTrials.gov ID
- NCT05813080
- Acronym / sponsor ID
- CARE / HeinrichHeine
- Conditions
- Psychotic Disorders, Prevention
- Keywords
- Psychosis-Risk Syndromes, high-risk, Cognitive Disturbances, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 14 Apr 2023 (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.
Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.
Detailed description
The study is a Investigator Initiated Trial (IIT)/Other clinical trial of a class 2a medical device according to article 82 medical devices regulation of the European Union.
The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis to actually develop a manifest psychosis.
Patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing.
The AI-supported algorithm "pronia.ai" uses information from both the individual patient data of the specialized routine diagnostics as well as from in-depth clinical diagnostics.
There are two predictions, an individual quantitative assessment of the individual risk of transition to psychosis and the individual prognosis with regard to the level of psychosocial functioning 12 months after inclusion in the study.
The therapists and patients receive a non-binding risk profile from the AI-based recommendation to adjust the treatment intensity from 16 to 24 sessions over a period of six months.
The cognitive behavioral therapy-based manual "Integrated Preventive Psychological Preventive Psychological Intervention (IPPI)" manual is used. In the treatment-as-usual arm (TAU),the patients receive referral back to the previous care system; further treatment (and additional diagnostics, if necessary) is left to the referring primary care providers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis to actually develop a manifest psychosis.
| Arm | Type | Receives |
|---|---|---|
| CARE interventional treatment | Experimental | Device: "pronia.ai" medical device for high risk psychosis prognosisAI-computerassisted prognosis of high risk psychosis profile and adapted study-specific therapy taking place in early-recognition centers. |
| Standard of Care Control arm | Active comparator | Other: Treatment-as-usual (TAU)Treatment as usual (TAU) patient will receive their usual treatment from their local physicians and therapeutic personnel. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- The increased risk of psychosis includes either a symptomatic "ultra high-risk" stage of the Structured Interview for Psychosis-Risk Syndromes or the "Cognitive Disturbances" risk criterion of the Schizophrenia Proneness Instrument - Children and Youth and Adult versions
- ages 16 to 40
- Presence of a written informed consent from the patient and, if applicable, the legal guardian.
Key exclusion criteria (14 listed)
- manifest psychosis according to the definition of the Structured Interview for Psychosis-Risk Syndromes (according to the PRONIA-study) (At least one P-syndrome with a rating of 6 on a daily frequency and for a period of more than one week)
- Lack of capacity to give consent (the patient lacks the capacity to consent if the individual case with regard to the specific treatment measure is excluded. Only when the physician has concrete indications that the patient's capacity to consent may be lacking, he may and must must examine it. Mental disorders (e.g. delirium, dementia, psychosis, mania, depression) or cognitive impairments can have an influence on the capacity to consent. Indications for doubts of a ability to give informed consent exist if the physician has the impression that the patient is not able to understand the provided patient information and is not able to reproduce essential information about the study in his or her own words and is not aware of the possible consequences of the proposed measures
- Severe suicidality during the recruitment phase (CDSS items 8 ≥2)
- A current or past neurological disease of the brain.
- a current or past known somatic disease that potentially affects the structure or function of the brain
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 |
|---|---|---|
| "pronia.ai" medical device for high risk psychosis prognosisIn addition to the computer-assisted prognosis of risk for reaching a psychosis, all patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing. Adapted psychological treatment will be offered consisting of 16 to 24 sessions over a period of six months. | Device | CARE interventional treatment |
| Treatment-as-usual (TAU)Referral back to the previous care system. Further treatment is left to the referring primary care providers. | Other | Standard of Care Control arm |
Primary outcome
Structured Interview for Psychosis-Risk Syndromes (SIPS)
Time frame: 12-month after inclusion
Presence of psychotic syndrome (POPS) criteria as modified according to the "PRONIA" study, resulting in a score of 0= "no psychosis" or 1= "psychosis"
18 secondary outcomes
Internalized Stigma of Mental Illness Scale (ISMI)
Time frame: 12-month after inclusion
Stigma-Stress-Scale
Time frame: 12-month after inclusion
Self-Identification of Mental Illness Scale (SELF-I)
Time frame: 12-month after inclusion
Coming-Out with Mental Illness Scale (COMIS)
Time frame: 12-month after inclusion
Secrecy and disclosure-related distress - scale
Time frame: 12-month after inclusion
Psychosis own health-concern single score
Time frame: 12-month after inclusion
Numeracy Scale
Time frame: 12-month after inclusion
Coping (Ten-Flex)
Time frame: 12-month after inclusion
Risk Perception Scale
Time frame: 12-month after inclusion
Risk Recall Scale
Time frame: 12-month after inclusion
Health-related quality of life (EQ-5D)
Time frame: 12-month after inclusion
Brief Multidimensional Life Satisfaction Scale (BMLSS)
Time frame: 12-month after inclusion
Client Sociodemographic and Service Receipt Inventory (CSSRI-EU)
Time frame: 12-month after inclusion
Patient Satisfaction Questionnaire (ZUF-8)
Time frame: 12-month after inclusion
Social and occupational assessment scale SOFAS
Time frame: 12-month after inclusion
Global Functioning Social Scale (GF:S)
Time frame: 12-month after inclusion
Global Functioning Role Scale (GF:R)
Time frame: 12-month after inclusion
Secrecy-Symptoms Scale
Time frame: 12-month after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 40533222Bommhardt T, Peschl J, Schultze-Lutter F, Koutsouleris N, Meisenzahl E, Koberlein-Neu J; CARE Study Group. Enhancing early detection and treatment of psychosis in Germany: a protocol for the health economic evaluation of an artificial intelligence-guided complex intervention. BMJ Open. 2025 Jun 18;15(6):e103151. doi: 10.1136/bmjopen-2025-103151.
- 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. This study is not recruiting at the moment.
Eva Meisenzahl-Lechner, Prof. principal investigator
Klinik und Poliklinik für Psychiatrie und Psychotherapie LVR-Klinikum Düsseldorf
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "pronia.ai" medical device for high risk psychosis prognosis and Treatment-as-usual (TAU) in people with Psychotic Disorders and Prevention, run by Heinrich-Heine University, Duesseldorf at 21 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Interview for Psychosis-Risk Syndromes (SIPS) (time frame: 12-month after inclusion). 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 NCT05813080, 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 18 Jun 2026.