Schizophrenia DisordersMon Psy & MoiNCT06818227
MonPsy&Moi: A Digital Platform for Collecting Patient-Reported Experience and Outcome Measures in Psychiatry
An observational study of Schizophrenia Disorders and Bipolar Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Mental health disorders, with a 30% annual prevalence rate, are a leading cause of disability and reduced life expectancy. Despite their impact, patient-reported experience measures (PREMs) and outcome measures (PROMs) are underutilized in psychiatry. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Disorders, Bipolar Disorders, Major Depression
- How many people
- 23,660 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2025to 21 Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adults residing in France and receiving care in 12 participating psychiatric facilities. The focus is on adults aged 18-65 with severe mental illnesses, such as schizophrenia spectrum disorders, bipolar disorders, and major depressive disorders. Participants must have a valid email address, understand French, and not oppose participation. Vulnerable populations, such as those under involuntary psychiatric care, are included to assess care quality, while individuals with organic mental disorders or those deprived of liberty are excluded.
Who may be able to join
- Residing in France. Age between 18 and 65 years at the time of inclusion.
- Receiving care in one of the 12 participating psychiatric facilities, with a confirmed diagnosis of:
- Schizophrenia Spectrum Disorders (e.g., schizophrenia, schizoaffective disorder).
- Bipolar Disorders. Major Depressive Disorders. A valid email address. Ability to read and understand French. Non-opposition to participating in the study (based on informed consent).
Who cannot join
- Primary diagnosis of an organic mental disorder, including:
- Dementia. Stroke. Traumatic brain injury. Individuals deprived of liberty by judicial decision (e.g., incarcerated patients).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MonPsyMoi: Etude Des Conditions d'implémentation et de l'Impact de la Plateforme Digitale française de Recueil de l'expérience Patient en Psychiatrie (Modules Avec et Sans " Feedback ")
Mental health disorders, with a 30% annual prevalence rate, are a leading cause of disability and reduced life expectancy. Despite their impact, patient-reported experience measures (PREMs) and outcome measures (PROMs) are underutilized in psychiatry. MonPsy\&Moi®, a digital platform funded by ATIH and DGOS, addresses this gap by providing a user-friendly tool to assess patient experiences and outcomes in real-time, aiming to improve the quality of psychiatric care across France.
The study consists of two stages:
Read more
Stage 1 (No Feedback): MonPsy\&Moi® is deployed across 12 psychiatric facilities, collecting patient data without feedback to clinicians. Objectives include assessing implementation feasibility, validating adaptive questionnaires (PREMIUM), and identifying predictors of patient outcomes, such as relapse and healthcare utilization.
Stage 2 (With Feedback): Focuses on patients with severe mental illnesses (schizophrenia, bipolar disorders, and major depressive disorders). This stage evaluates the impact of providing PREMs/PROMs feedback to clinicians on relapse rates, healthcare costs, and overall patient outcomes.
MonPsy\&Moi® uses adaptive questionnaires tailored to psychiatric care, covering key domains such as dignity, information, interpersonal relationships, care environment, and treatment. It also evaluates health-related quality of life, including psychological well-being, autonomy, self-esteem, and social relationships. The platform integrates with national healthcare databases (SNDS) to enhance data analysis and predict patient trajectories.
The study will involve over 22,000 participants in Stage 1 and 1,100 participants in Stage 2, using a quasi-experimental design to compare feedback and non-feedback strategies. Results aim to demonstrate the feasibility, acceptability, and efficacy of MonPsy\&Moi® in improving mental health outcomes and guiding national psychiatric care policies.
By empowering patients and clinicians with actionable insights, MonPsy\&Moi® aspires to set a new standard for patient-centered mental healthcare in real-world settings
- Conditions
- Schizophrenia Disorders, Bipolar Disorders, Major Depression
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psychiatric patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse at 12 Months
Relapse is defined as one or more of the following events occurring within 12 months:Full-time psychiatric hospitalization, Psychiatric emergency care.
Hospitalization due to a suicide attempt, Death.
Measured: within 12 months
Secondary outcomes (2)
Impact of Feedback on healthcare resource utilization
Mortality at 6 and 12 months.
Measured: 6 and 12 months post-inclusion
Cost-Effectiveness Analysis
Incremental cost-effectiveness ratio (ICER) and cost-utility analysis (cost per relapse avoided or per quality-adjusted life year [QALY] gained).
Measured: 12 months post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start2 Feb 2025 (estimated)
- Primary completion21 Sep 2026 (estimated)
- Study completion21 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies 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
- 23,660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818227
- Sponsor's protocol ID
- RCAPHM21_0429
- Acronym
- Mon Psy & Moi
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MonPsyMoi: Etude Des Conditions d'implémentation et de l'Impact de la Plateforme Digitale française de Recueil de l'expérience Patient en Psychiatrie (Modules Avec et Sans " Feedback ")
- ClinicalTrials.gov ID
- NCT06818227
- Acronym / sponsor ID
- Mon Psy & Moi / RCAPHM21_0429
- Conditions
- Schizophrenia Disorders, Bipolar Disorders, Major Depression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 23,660 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Feb 2025 (estimated)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 21 Sep 2026 (estimated)
- First posted
- 10 Feb 2025 (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.
Mental health disorders, with a 30% annual prevalence rate, are a leading cause of disability and reduced life expectancy. Despite their impact, patient-reported experience measures (PREMs) and outcome measures (PROMs) are underutilized in psychiatry. MonPsy\&Moi®, a digital platform funded by ATIH and DGOS, addresses this gap by providing a user-friendly tool to assess patient experiences and outcomes in real-time, aiming to improve the quality of psychiatric care across France.
The study consists of two stages:
Stage 1 (No Feedback): MonPsy\&Moi® is deployed across 12 psychiatric facilities, collecting patient data without feedback to clinicians. Objectives include assessing implementation feasibility, validating adaptive questionnaires (PREMIUM), and identifying predictors of patient outcomes, such as relapse and healthcare utilization.
Stage 2 (With Feedback): Focuses on patients with severe mental illnesses (schizophrenia, bipolar disorders, and major depressive disorders). This stage evaluates the impact of providing PREMs/PROMs feedback to clinicians on relapse rates, healthcare costs, and overall patient outcomes.
MonPsy\&Moi® uses adaptive questionnaires tailored to psychiatric care, covering key domains such as dignity, information, interpersonal relationships, care environment, and treatment. It also evaluates health-related quality of life, including psychological well-being, autonomy, self-esteem, and social relationships. The platform integrates with national healthcare databases (SNDS) to enhance data analysis and predict patient trajectories.
The study will involve over 22,000 participants in Stage 1 and 1,100 participants in Stage 2, using a quasi-experimental design to compare feedback and non-feedback strategies. Results aim to demonstrate the feasibility, acceptability, and efficacy of MonPsy\&Moi® in improving mental health outcomes and guiding national psychiatric care policies.
By empowering patients and clinicians with actionable insights, MonPsy\&Moi® aspires to set a new standard for patient-centered mental healthcare in real-world settings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychiatric patients | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults residing in France and receiving care in 12 participating psychiatric facilities. The focus is on adults aged 18-65 with severe mental illnesses, such as schizophrenia spectrum disorders, bipolar disorders, and major depressive disorders. Participants must have a valid email address, understand French, and not oppose participation. Vulnerable populations, such as those under involuntary psychiatric care, are included to assess care quality, while individuals with organic mental disorders or those deprived of liberty are excluded.
Key inclusion criteria (4 listed)
- Residing in France. Age between 18 and 65 years at the time of inclusion.
- Receiving care in one of the 12 participating psychiatric facilities, with a confirmed diagnosis of:
- Schizophrenia Spectrum Disorders (e.g., schizophrenia, schizoaffective disorder).
- Bipolar Disorders. Major Depressive Disorders. A valid email address. Ability to read and understand French. Non-opposition to participating in the study (based on informed consent).
Key exclusion criteria (2 listed)
- Primary diagnosis of an organic mental disorder, including:
- Dementia. Stroke. Traumatic brain injury. Individuals deprived of liberty by judicial decision (e.g., incarcerated patients).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse at 12 Months
Time frame: within 12 months
Relapse is defined as one or more of the following events occurring within 12 months:Full-time psychiatric hospitalization, Psychiatric emergency care. Hospitalization due to a suicide attempt, Death.
2 secondary outcomes
Impact of Feedback on healthcare resource utilization
Time frame: 6 and 12 months post-inclusion
Cost-Effectiveness Analysis
Time frame: 12 months post-inclusion
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 10 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia Disorders
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia Disorders and Bipolar Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Laurent BOYER, Pr (+33491835266, Laurent.BOYER@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse at 12 Months (time frame: within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.