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NCT Number: NCT06818227

MonPsy&Moi: A Digital Platform for Collecting Patient-Reported Experience and Outcome Measures in Psychiatry

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

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Key information

Conditions

Schizophrenia Disorders Bipolar Disorder Bipolar Disorders Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Primary diagnosis of an organic mental disorder, including:

Dementia. Stroke. Traumatic brain injury. Individuals deprived of liberty by judicial decision (e.g., incarcerated patients).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Impact of Feedback on healthcare resource utilization

    Time frame: 6 and 12 months post-inclusion

    Mortality at 6 and 12 months.

  2. Cost-Effectiveness Analysis

    Time frame: 12 months post-inclusion

    Incremental cost-effectiveness ratio (ICER) and cost-utility analysis (cost per relapse avoided or per quality-adjusted life year [QALY] gained).

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent BOYER, Pr

CONTACT

[email protected]

+33491835266

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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 ")

Acronym: Mon Psy & Moi

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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