Psychiatric DisorderVOILE_RPS93NCT07354633
Full Sail Ahead, Sailing in Psychosocial Rehabilitation.
A study testing sailing and taking care in rehabilitation psychosocial in people with Psychiatric Disorder, run by Centre hospitalier de Ville-Evrard, France at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- sailing and taking care in rehabilitation psychosocial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding woman
- Psychiatric decompensation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Rusheenthira Thavaseelan
Neuilly-sur-Marne, 93330
Rusheenthira thavaseelan, master, 0143093232, r.thavaseelan@epsve.fr
Pierre LECARPENTIER
- Recruiting
EPS VIlle Evrard - UNIRRE 93
Neuilly-sur-Marne
Raluca Rosetti, +33613616270, r.rosetti@epsve.fr
About this study
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.
Read the 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.
- Conditions
- Psychiatric Disorder
- Being tested
- sailing, taking care in rehabilitation psychosocial
- Keywords
- Sailing, psychiatric disorder, physical conditions
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sailingBehavioural
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)
taking care in rehabilitation psychosocialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| sailing arm | Active comparator | 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) Receives: Behavioral: sailing |
| control | Placebo comparator | 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. Receives: Behavioral: taking care in rehabilitation psychosocial |
What is being measured
The primary outcome is the main question the study is designed to answer.
scale of quality of life
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.
Measured: T0: before sailing starts
Scale of quality of life
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.
Measured: T1: within 10 minutes after the end of sailing
Scale of quality of life
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.
Measured: T2: Three months After Sailing
Warwick Edinburgh mental well being scale
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.
Measured: T0: Before sailing starts
Warwick Edinburgh mental well being scale
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.
Measured: T1: within 10 minutes after the end of sailing
Warwick Edinburgh mental well being scale
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.
Measured: T2: Three months After Sailing
Self-Esteem Scale
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.
Measured: T0: before sailing starts
Self-Esteem Scale
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.
Measured: T1: within 10 minutes after the end of sailing
Self-Esteem Scale
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.
Measured: T2: Three months After Sailing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- one group is voile and the other one is control.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raluca ROSETTI, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354633
- Sponsor's protocol ID
- VOILE_RPS93_10477M
- Acronym
- VOILE_RPS93
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Sail Ahead, Sailing in Psychosocial Rehabilitation.
- ClinicalTrials.gov ID
- NCT07354633
- Acronym / sponsor ID
- VOILE_RPS93 / VOILE_RPS93_10477M
- Conditions
- Psychiatric Disorder
- Keywords
- Sailing, psychiatric disorder, physical conditions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jan 2026 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one group is voile and the other one is control.
| Arm | Type | Receives |
|---|---|---|
| sailing arm | Active comparator | Behavioral: sailing20 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) |
| control | Placebo comparator | Behavioral: taking care in rehabilitation psychosocial20 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding woman
- Psychiatric decompensation
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 |
|---|---|---|
| sailingUsers 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) | Behavioural | sailing arm |
| taking care in rehabilitation psychosocialcontrol 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. | Behavioural | control |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 21 Jan 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sailing and taking care in rehabilitation psychosocial in people with Psychiatric Disorder, run by Centre hospitalier de Ville-Evrard, France at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Rusheenthira thavaseelan, master (0143093232, r.thavaseelan@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scale of quality of life (time frame: T0: before sailing starts). The study lists 9 primary outcomes in all. 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 21 Jan 2026.