Full Sail Ahead, Sailing in Psychosocial Rehabilitation. (VOILE_RPS93)

January 12, 2026 updated by: Raluca ROSETTI, Centre hospitalier de Ville-Evrard, France
This study is part of the desire to develop disabled sports in the territory of Seine-Saint-Denis and responds to the national strategy plan Sport Santé, 2019-2024, which addresses all audiences. The law of January 26, 2016 recognizes sport as a non-drug therapeutic in its own right, becoming an element of the hospital care pathway but also ambulatory. The partnership between the EPS of Ville-Evrard and the departmental committee of Voile du 93, co-funder of the project thus allows the diversification and the increase of the offer of care in psychosocial rehabilitation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sailing is integrated into the psychosocial rehabilitation offer for people with severe psychological disorders, for example in Italy . Since 2021, the Psychosocial Rehabilitation Reference Unit (UNIRRE 93) of the Ville-Evrard hospital has been using sailing as a therapeutic intervention. After 4 years of implementation within the psychosocial rehabilitation referral unit in Seine-Saint-Denis, this innovative care needs to be evaluated and shared within the psychiatric care community. This study is part of the desire to develop disabled sports in the territory of Seine-Saint-Denis and responds to the national strategy plan Sport Santé, 2019-2024, which addresses all audiences.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Neuilly-sur-Marne, France
        • Recruiting
        • EPS VIlle Evrard - UNIRRE 93
        • Contact:
      • Neuilly-sur-Marne, France, 93330
        • Recruiting
        • Rusheenthira Thavaseelan
        • Contact:
        • Contact:
          • Pierre LECARPENTIER
        • Principal Investigator:
          • RALUCA ROSETTI, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Obtaining free and informed consent to the research project
  • User over 18 years old and living in the 93
  • Living with a psychic or neurodevelopmental disorder
  • Supported by the RPS 93 platform
  • Have obtained a medical certificate of fitness for sailing including competition (only for the sailing group)
  • Knowing French language ( how to read and write)
  • Clinical condition stabilized for less than three months despite taking medication

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Psychiatric decompensation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: sailing arm
20 users followed in the psychosocial rehabilitation unit (UNIRRE 93) and practicing the sailing activity by session of 10 sailing sessions over two periods (March to June and August to November) Twice a year (month)
Behavioral: sailing
Users followed in the psychosocial rehabilitation unit (UNIRRE 93) and practicing the sailing activity by session of 10 sailing sessions over two periods (March to June and August to November) Twice a year (month)
Placebo Comparator: control
20 control subjects: users followed in the psychosocial rehabilitation unit (UNIRRE 93) and taken care of in psychosocial rehabilitation without a veil over the same period as a "veil" session.
Behavioral: taking care in rehabilitation psychosocial
control subjects: users followed in the psychosocial rehabilitation unit (UNIRRE 93) and taken care of in psychosocial rehabilitation without a veil over the same period as a "veil" session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
scale of quality of life
Time Frame: T0: before sailing starts
The questionnaire is a validated health-related quality of life scale. The scale is also recommended by the HAS to evaluate clinical practices. It is composed of 36 elements, including eight scales focusing on health: general physical state, limitations of roles related to physical health, body pain, general perception of health, vitality, social functioning, limitations of roles related to mental health. The scale can be auto or hetero administered and requires 5 to 10 minutes of handover.
T0: before sailing starts
Scale of quality of life
Time Frame: T1: within 10 minutes after the end of sailing
The questionnaire is a validated health-related quality of life scale. The scale is also recommended by the HAS to evaluate clinical practices. It is composed of 36 elements, including eight scales focusing on health: general physical state, limitations of roles related to physical health, body pain, general perception of health, vitality, social functioning, limitations of roles related to mental health. The scale can be auto or hetero administered and requires 5 to 10 minutes of handover.
T1: within 10 minutes after the end of sailing
Scale of quality of life
Time Frame: T2: Three months After Sailing
The questionnaire is a validated health-related quality of life scale. The scale is also recommended by the HAS to evaluate clinical practices. It is composed of 36 elements, including eight scales focusing on health: general physical state, limitations of roles related to physical health, body pain, general perception of health, vitality, social functioning, limitations of roles related to mental health. The scale can be auto or hetero administered and requires 5 to 10 minutes of handover.
T2: Three months After Sailing
Warwick Edinburgh mental well being scale
Time Frame: T0: Before sailing starts
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated tool designed to measure mental wellbeing in individuals and populations, consisting of 14 positively worded items scored on a 5-point Likert scale.All items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a 1 (Never) to 5 (All the time) Likert scale. The minimum scale score is 14 and the maximum is 70. Higher scores indicate better mental well being.
T0: Before sailing starts
Warwick Edinburgh mental well being scale
Time Frame: T1: within 10 minutes after the end of sailing
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated tool designed to measure mental wellbeing in individuals and populations, consisting of 14 positively worded items scored on a 5-point Likert scale.All items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a 1 (Never) to 5 (All the time) Likert scale. The minimum scale score is 14 and the maximum is 70. Higher scores indicate better mental well being.
T1: within 10 minutes after the end of sailing
Warwick Edinburgh mental well being scale
Time Frame: T2: Three months After Sailing
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated tool designed to measure mental wellbeing in individuals and populations, consisting of 14 positively worded items scored on a 5-point Likert scale.All items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a 1 (Never) to 5 (All the time) Likert scale. The minimum scale score is 14 and the maximum is 70. Higher scores indicate better mental well being.
T2: Three months After Sailing
Self-Esteem Scale
Time Frame: T0: before sailing starts
Rosenberg's Self-esteem Scale By Nathalie Crépin and Florence Delerue Self-esteem is defined as the judgment or evaluation one makes of oneself, of one's value personal. In a simpler way, self-esteem can also be assimilated to self-affirmation. Esteem of oneself is an essential factor in sports performance.This scale represents a French cross-cultural validation of the Rosenberg Self-Esteem Scale (1965). It contains 10 items, five positive and five negative assessed on a 1 to 4-point scale It takes only 8 minutes to do the scale.
T0: before sailing starts
Self-Esteem Scale
Time Frame: T1: within 10 minutes after the end of sailing
Rosenberg's Self-esteem Scale By Nathalie Crépin and Florence Delerue Self-esteem is defined as the judgment or evaluation one makes of oneself, of one's value personal. In a simpler way, self-esteem can also be assimilated to self-affirmation. Esteem of oneself is an essential factor in sports performance.This scale represents a French cross-cultural validation of the Rosenberg Self-Esteem Scale (1965). It contains 10 items, five positive and five negative assessed on a 1 to 4-point scale It takes only 8 minutes to do the scale.
T1: within 10 minutes after the end of sailing
Self-Esteem Scale
Time Frame: T2: Three months After Sailing
Rosenberg's Self-esteem Scale By Nathalie Crépin and Florence Delerue Self-esteem is defined as the judgment or evaluation one makes of oneself, of one's value personal. In a simpler way, self-esteem can also be assimilated to self-affirmation. Esteem of oneself is an essential factor in sports performance.This scale represents a French cross-cultural validation of the Rosenberg Self-Esteem Scale (1965). It contains 10 items, five positive and five negative assessed on a 1 to 4-point scale It takes only 8 minutes to do the scale.
T2: Three months After Sailing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de Ville-Evrard, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VOILE_RPS93_10477M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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