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

Not yet recruiting

• Conditions: Schizophrenia Disorders; Bipolar Disorders; Major Depression

• Registration Number: NCT06818227
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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. 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study Start: 2025-02-02
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-09-21
• Study Completion: 2026-09-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 23660

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse at 12 Months	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 Outcome Measures

Name	Time	Method
Cost-Effectiveness Analysis	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).
Impact of Feedback on healthcare resource utilization	6 and 12 months post-inclusion	Mortality at 6 and 12 months.

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 MArseille, France