At-risk Mental StatesITIPNCT07633899
The Influence of Tennis in Early Intervention
A study testing Tennis ( physical activity) and Self-esteem program in people with At-risk Mental States and First Episode Psychosis (FEP), run by Centre Hospitalier Esquirol at 1 site in France.
Trial summary
This study involves two groups of participants: one participating in an intervention focused on self-esteem-and thus primarily psychological-and the other on self-esteem and tennis-and thus involving physical activity. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- At-risk Mental States, First Episode Psychosis (FEP)
- What is being tested?
- Tennis ( physical activity) and Self-esteem program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 30 years diagnosed with at-risk mental state or first episode psychosis
Who cannot join
- Motor disability
- intellectual disability,
- depression,
- insufficient French language proficiency,
- subject's refusal,
- currently undergoing cognitive remediation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Tennis in Early Intervention (ITIP): a Pilot Study
This study involves two groups of participants: one participating in an intervention focused on self-esteem-and thus primarily psychological-and the other on self-esteem and tennis-and thus involving physical activity. The objectives of this study are to document participants' experiences following their participation in the group offered to them, as well as to quantify any changes in the various areas detailed below. In this study, we aim to identify the benefits gained following a group intervention in the social, academic/professional, clinical, and physical domains; we also seek to objectively assess any changes in cognition, self-esteem, perceived physical value, quality of life, social functioning, negative symptoms, and self-stigmatization.
Read the detailed description
- Background Physical activity can be defined as any movement or contraction produced by skeletal muscles that results in an increase in energy expenditure beyond that at rest. In the general population, low levels of physical activity are considered one of the leading causes of mortality, constituting a risk factor for cardiovascular disease. The findings are similar among individuals with psychiatric disorders. Various studies have indeed examined the effects of physical activity in schizophrenia. Some authors therefore highlight the benefits regarding physical fitness, the severity of both negative and positive symptoms, anxiety-depressive symptoms, as well as cognitive, social, and cardiovascular functioning and quality of life. As a result, intervention programs for schizophrenia that incorporate sports activities have been developed, such as RemedRugby, which consists not only of playing Touch Rugby but also of psychoeducation, cognitive and social remediation, and social skills training-a program that has demonstrated benefits in terms of cognitive and social functioning, quality of life, and self-stigmatization. Since the goal of intervention is to intervene as early as possible to limit the transition to psychosis, other authors have examined sports participation among patients at risk for psychosis. Koivukangas et al. found that adolescents who later developed psychosis were three to four times less physically active, with an inverse correlation between the number of prodromal symptoms and physical activity. This inactivity is in fact associated with dysfunction in the frontal lobes, with the hippocampal impairment mentioned earlier already present in the prodromal phase of the illness. Furthermore, Chalfoun et al. note that young patients with early-onset psychosis are at higher risk of weight gain upon initiation of antipsychotic treatment, providing further support for interventions based on physical activity. When asked, young people classified as Ultra High Risk (UHR) linked their physical inactivity to low motivation and the presence of anxiety and depressive symptoms, which further reinforced their social withdrawal. However, a desire to improve their physical health emerged from this study by Carney et al. by offering them activities tailored to their challenges, which could, among other things, improve their self-esteem. Dean et al. also demonstrated that three months of sports participation enabled UHR youth to improve not only their symptom expression but also their cognitive and social functioning. Similarly, physical activity appears to be a resource for individuals who have experienced a First Psychotic Episode (FPE), as it can help limit weight gain associated with antipsychotics, as previously noted by Chalfoun et al. It may also help reduce psychotic symptoms and provide an outlet, improve cognitive functioning, promote social interactions, and foster a sense of purpose and control. Given the research investigating the benefits of physical activity in individuals with schizophrenia and the growing interest in emerging pathologies among young adults, the present study hypothesizes that group tennis practice will have benefits on the symptomatology, cognition, and functioning of UHR/PEP individuals.
- Participants INCLUSION CRITERIA Patients aged 18 to 30 years receiving care at the e-DIP and presenting with UHR/PEP EXCLUSION CRITERIA
- Motor disability
- intellectual disability,
- depression,
- insufficient French language proficiency,
- subject's refusal,
- currently undergoing cognitive remediation
EXCLUSION CRITERIA Physical injury, psychological decompensation, inpatient hospitalization Absence from a tennis or self-esteem group session does not constitute a criterion for exclusion. Regarding tennis, participation in at least 6 sessions is required for the data to be analyzable. Regarding self-esteem, any missed session will be made up in an individual format.
3 Procedures
: This is an open-label prospective study consisting of two unmatched parallel groups. Each group will consist of 4 experimental subjects and 4 control subjects.
Participants will undergo a pre-inclusion visit, during which the research project will be presented; then, during the inclusion visit (M0), informed consent, various sociodemographic data, medication information, and results from neuropsychological tests and scales will be collected. These include (estimated total duration 60-80 minutes):
- Rosenberg Self-Esteem Scale, commonly used in practice due to its short administration time (estimated 1-2 minutes) and psychometric properties; it consists of 10 statements regarding self-perception to be rated on a 4-point Likert scale ("strongly disagree," "somewhat disagree," "somewhat agree," "strongly agree") (Rosenberg, 1965; Vallieres \& Vallerand, 1990)
- 25-item Physical Self-Concept Inventory (ISP-25), assessing 5 dimensions, namely general self-esteem, perceived physical worth, physical fitness, athletic ability, physical appearance, and perceived strength using a 6-point Likert scale (ranging from "not at all" to "completely"); estimated duration 2-3 minutes (Ninot et al., 2000).
- Quality of Life Scale (WHOQOL-Bref), developed by the World Health Organization to assess general quality of life across four domains: physical health, social well-being, social relationships, and environment; rated on a 5-point Likert scale (ranging from "very poor" to "very good," "very dissatisfied/not at all satisfied" to "very satisfied," "not at all" to "extremely/completely/very much," or "never" to "always" depending on the item); estimated completion time of 2-3 minutes.
- Social Functioning Scale (QFS), developed for patients in psychiatric care and assessing, over the past 2 weeks, both the frequency of social behaviors and satisfaction with them, and demonstrating sensitivity to change; rated on a 5-point Likert scale (ranging from "every day" to "never" and from "very satisfied" to "very dissatisfied"); estimated time: 2-3 minutes.
- Negative Symptom Scale (SNS), validated in French, which uses a 3-point Likert scale ("strongly agree," "somewhat agree," "strongly disagree") 20 items covering social withdrawal, diminished emotional experience, alogia, avolition, and anhedonia; estimated duration 1-2 minutes.
- Self-Stigma Scale (ISMI) assessing, on a 4-point Likert scale (ranging from "strongly agree" to "strongly disagree"), 29 items leading to a total self-stigma score in individuals with a mental health disorder (estimated time: 2-3 minutes). Six subscores can be calculated, distinguishing between alienation, endorsement of stereotypes, experiences of discrimination, social withdrawal, and resistance to stigma.
- Commonly used neuropsychological tests with demonstrated psychometric qualities.
- RL/RI-16, assessing verbal memory through the learning of a list of 16 words in short-term memory and after a 20-minute delay (estimated duration 20-30 minutes); scoring of words recalled in immediate recall, 3 free recalls, and 3 total recalls according to established norms
- d2-R: assessment of attention via a 5-minute interference task; scoring of concentration ability, processing speed, and accuracy percentage according to established norms
- WAIS-IV Digit Span, assessing working memory via a span task in direct, indirect, and reverse orders, lasting 5 to 10 minutes; scoring of the total number of correct items according to established norms
- TMT A and B, assessing reactive flexibility via a dot-connecting task with alternating instructions, duration 2 to 3 minutes; scoring of time and errors according to established norms
- WAIS-IV codes, assessing processing speed via a graphomotor execution task, duration 2 minutes; scoring of the number of correct responses according to established norms
- Stroop, assessing inhibition via the "interference" sheet following the "naming" and "reading" control sheets, duration of 5 minutes; scoring of time and errors according to established norms
Participants will take part in 8 one-hour tennis sessions led by a certified instructor (the number of sessions will be determined in consultation with the instructor, taking into account the patients' specific needs), which will proceed as follows:
- Approximately 5-minute welcome period for participants
- Approximately 5-minute warm-up around the court
- Practice time: getting comfortable with the racket and first rallies in Session 1, adding forehand/backhand alternating drills in Session 2, adding serves and 1-on-1 rallies on half-court in Session 3, repeating the drills and increasing the complexity of the instructions for the remaining sessions
- Putting away equipment and restoring the clay court and/or a self-esteem group inspired by Tania Lecomte's "I'm Awesome!" module, consisting of 9 sessions of 1 hour and 30 minutes each, structured as follows:
- Watching a video introducing the concept of self-esteem (YouTube channel "Et tout le monde s'en fout")
- Work on the sense of security in sessions 1 and 2
- Working on a sense of identity in sessions 3 and 4
- Working on a sense of belonging in sessions 4 and 5
- Working on a sense of direction in sessions 6 and 7
- Working on a sense of competence in sessions 8
- Group conclusion and "Self-Esteem in 3D" dice game Finally, participants will undergo the same neuropsychological and psychometric assessment described earlier at the end of the study (M3). 4 Objectives Primary Objective To compare the subjective experiences in the social, academic/professional, clinical, and physical domains between a group participating in tennis combined with a self-esteem program and a group participating only in a self-esteem program Secondary Objectives
To compare a group participating in tennis combined with a self-esteem program with a group participating only in a self-esteem program:
- cognitive performance,
- overall self-esteem
- perceived physical value
- quality of life,
- social functioning,
- negative symptoms
- self-stigmatization
Evaluation criteria Primary outcome measure
- 10-point visual Likert scale (ranging from 0 "not at all well" to 10 "very well") to assess participants' feelings before and after the intervention in the social, academic/professional, clinical, and physical domains, as well as their qualitative comments ("How do you feel in the … domain?")
Secondary outcome measures
- Neuropsychological tests assessing: verbal memory (RL/RI-16), attention (d2-R), working memory (WAIS-IV Digit Span), flexibility (TMT A and B), processing speed (WAIS-IV Coding), and inhibition (Stroop Interference Task)
- Self-Esteem Scale (Rosenberg Scale),
- Physical Self-Concept Inventory (ISP-25)
- Quality of Life Scale (WHOQOL-Bref scale),
- Social Functioning Scale (QFS)
- Negative Symptom Scale (SNS),
- Self-Stigma Index (ISMI)
- Being tested
- Tennis ( physical activity), Self-esteem program
- Keywords
- at-risk mental states, first episode psychosis, physical activity, early intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tennis ( physical activity)Other
Eight tennis sessions, each lasting 1 hour and 15 minutes, led by a sports instructor specializing in tennis and a nurse case manager. The sessions took place at a tennis club.
Self-esteem programOther
The self-esteem program is called "I'm Great!" by Tania Lecomte et al., and has been validated in early intervention settings. 6 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Tennis + Self esteem program | Experimental | Participants in Group 1 took part in 8 tennis sessions and 6 self-esteem sessions. Receives: Other: Tennis ( physical activity); Other: Self-esteem program |
| Group 2: self-esteem program | Active comparator | Participants in Group 2 only took part in 6 self-esteem sessions. Receives: Other: Self-esteem program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective experiences in the social, academic/professional, clinical, and physical domains, 10-point visual Likert scale
10-point visual Likert scale (ranging from 0 "not at all well" to 10 "very well") to assess participants' feelings before and after the intervention in the social, academic/professional, clinical, and physical domains, as well as their qualitative comments ("How do you feel in the … domain?"). A higher score means a better outcome.
Measured: 2 minutes
Secondary outcomes (12)
Rappel Libre / Rappel Indicé - 16 (RL/RI-16).
A neuropsychological memory test that assesses verbal episodic memory through free recall and cued recall of 16 words.
Minimum score 0, maximum Score 48. A higher score means a better outcome.
Measured: 15 minutes
d2-R
A neuropsychological attention test that measures selective attention, concentration, and processing speed through a visual cancellation task.
d2-R: The d2-R does not have a single fixed minimum or maximum score because it yields several indices, including the total number of processed items, omission and commission errors, concentration performance, and error percentage. While some indices have a minimum score of 0, their maximum values depend on the number of items completed during the task. Therefore, performance is typically interpreted using age-adjusted normative scores, such as percentiles or standard scores, rather than fixed raw score ranges.
A better score means a better outcome.
Measured: 5 minutes
WAIS-IV Digit Span
A neuropsychological subtest that assesses attention, working memory, and mental manipulation by requiring the repetition of number sequences.
Minimum score 0, maximum score 48.
Measured: 5 to 10 minutes
Trail Marking Tests TMT A and B
TMT-A: A neuropsychological test that measures visual scanning, attention, and processing speed by connecting numbered items in sequence.
TMT-B: A neuropsychological test that measures cognitive flexibility and executive functioning by alternating between numbers and letters in sequence.
TMT-A: The Trail Making Test Part A has no fixed theoretical maximum score; performance is measured as the time to completion (typically in seconds, with no upper limit) and the number of errors, with most healthy adults completing it in about 20-60 seconds.
TMT-B: The Trail Making Test Part B also has no fixed maximum score; it is scored primarily by completion time (usually in seconds, with no upper limit) and errors, with typical completion times for healthy adults around 40-180 seconds, depending on age and education.
both TMT-A and TMT-B, a higher score (longer completion time) indicates a worse performance.
Measured: 2 minutes
WAIS-IV Coding
A neuropsychological subtest that assesses processing speed, visual-motor coordination, and sustained attention through a timed symbol-coding task.
The Coding subtest of the WAIS-IV does not have a fixed minimum or maximum raw score in terms of time-based performance; instead, raw scores typically range from 0 up to around 100-110 correct symbol-digit pairings, depending on the number of items attempted and accuracy.
A higher score means a better performance
Measured: 5 to 10 minutes
Stroop Interference Task
A neuropsychological test that assesses inhibitory control and cognitive flexibility by requiring individuals to suppress automatic reading responses in favor of naming ink colors.
The Stroop test does not have fixed minimum or maximum raw scores, as performance is usually measured through reaction time (in seconds) and number of errors, particularly in the interference condition. n general, longer reaction times and more errors indicate poorer inhibitory control, while faster responses with fewer errors indicate better performance.
Measured: 5 minutes
Rosenberg Scale
A self-report questionnaire that assesses global self-esteem through ratings of positive and negative self-beliefs.
Minimum score 0, maximum 30. Higher scores indicate higher global self-esteem, while lower scores reflect lower self-esteem.
Measured: 2 minutes
Physical Self-Concept Inventory (ISP-25)
A self-report questionnaire that assesses individuals' perceptions of their physical self across dimensions such as physical ability, appearance, strength, and physical self-worth. Total score range from 25 to 125, higher scores indicating a more positive physical self-concept.
Measured: 2 to 3 minutes
WHOQOL-Bref scale
A self-report questionnaire developed by the World Health Organization that assesses perceived quality of life across physical, psychological, social, and environmental domains. The WHOQOL-BREF is a 26-item self-report questionnaire scored across four domains (physical health, psychological health, social relationships, and environment), with each domain transformed to a 0-100 scale where higher scores indicate better perceived quality of life.
Measured: 2 to 3 minutes
Social Functioning Scale (QFS)
A self-report questionnaire that assesses social functioning and community participation across domains such as social engagement, interpersonal behavior, recreation, and independent living.
The Social Functioning Scale is a self-report measure assessing social and community functioning, typically producing domain scores that are standardized (often converted to T-scores or z-scores) rather than a single fixed raw total score range, with higher scores indicating better social functioning.
Measured: 2 to 3 minutes
Negative Symptom Scale (SNS)
A self-report questionnaire that assesses the severity of negative symptoms, including social withdrawal, reduced emotional expression, avolition, anhedonia, and alogia.
The SNS is a self-report scale with multiple items rated on Likert-type responses, yielding a total score range from 0 to 30, where higher scores indicate more severe negative symptoms.
Measured: 1 to 2 minutes
Self-Stigma Index (ISMI)
A self-report questionnaire that assesses the extent to which individuals internalize stigma related to mental illness, including feelings of alienation, stereotype endorsement, discrimination, and social withdrawal.
The ISMI is a self-report questionnaire composed of multiple Likert-rated items, typically producing a mean or total score ranging from 1 to 4, where higher scores indicate greater internalized stigma.
Measured: 2 to 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start13 Oct 2022
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for At-risk Mental StatesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mirvat HAMDAN-DUMONT, Centre Hospitalier Esquirol
- Investigators
- Mirvat Hamdan-Dumont, MD, PhD, Principal investigator, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633899
- Sponsor's protocol ID
- 2022-A01406-37
- Acronym
- ITIP
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Tennis in Early Intervention (ITIP): a Pilot Study
- ClinicalTrials.gov ID
- NCT07633899
- Acronym / sponsor ID
- ITIP / 2022-A01406-37
- Keywords
- at-risk mental states, first episode psychosis, physical activity, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 8 Jun 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 involves two groups of participants: one participating in an intervention focused on self-esteem-and thus primarily psychological-and the other on self-esteem and tennis-and thus involving physical activity. The objectives of this study are to document participants' experiences following their participation in the group offered to them, as well as to quantify any changes in the various areas detailed below. In this study, we aim to identify the benefits gained following a group intervention in the social, academic/professional, clinical, and physical domains; we also seek to objectively assess any changes in cognition, self-esteem, perceived physical value, quality of life, social functioning, negative symptoms, and self-stigmatization.
Detailed description
- Background Physical activity can be defined as any movement or contraction produced by skeletal muscles that results in an increase in energy expenditure beyond that at rest. In the general population, low levels of physical activity are considered one of the leading causes of mortality, constituting a risk factor for cardiovascular disease. The findings are similar among individuals with psychiatric disorders. Various studies have indeed examined the effects of physical activity in schizophrenia. Some authors therefore highlight the benefits regarding physical fitness, the severity of both negative and positive symptoms, anxiety-depressive symptoms, as well as cognitive, social, and cardiovascular functioning and quality of life. As a result, intervention programs for schizophrenia that incorporate sports activities have been developed, such as RemedRugby, which consists not only of playing Touch Rugby but also of psychoeducation, cognitive and social remediation, and social skills training-a program that has demonstrated benefits in terms of cognitive and social functioning, quality of life, and self-stigmatization. Since the goal of intervention is to intervene as early as possible to limit the transition to psychosis, other authors have examined sports participation among patients at risk for psychosis. Koivukangas et al. found that adolescents who later developed psychosis were three to four times less physically active, with an inverse correlation between the number of prodromal symptoms and physical activity. This inactivity is in fact associated with dysfunction in the frontal lobes, with the hippocampal impairment mentioned earlier already present in the prodromal phase of the illness. Furthermore, Chalfoun et al. note that young patients with early-onset psychosis are at higher risk of weight gain upon initiation of antipsychotic treatment, providing further support for interventions based on physical activity. When asked, young people classified as Ultra High Risk (UHR) linked their physical inactivity to low motivation and the presence of anxiety and depressive symptoms, which further reinforced their social withdrawal. However, a desire to improve their physical health emerged from this study by Carney et al. by offering them activities tailored to their challenges, which could, among other things, improve their self-esteem. Dean et al. also demonstrated that three months of sports participation enabled UHR youth to improve not only their symptom expression but also their cognitive and social functioning. Similarly, physical activity appears to be a resource for individuals who have experienced a First Psychotic Episode (FPE), as it can help limit weight gain associated with antipsychotics, as previously noted by Chalfoun et al. It may also help reduce psychotic symptoms and provide an outlet, improve cognitive functioning, promote social interactions, and foster a sense of purpose and control. Given the research investigating the benefits of physical activity in individuals with schizophrenia and the growing interest in emerging pathologies among young adults, the present study hypothesizes that group tennis practice will have benefits on the symptomatology, cognition, and functioning of UHR/PEP individuals.
- Participants INCLUSION CRITERIA Patients aged 18 to 30 years receiving care at the e-DIP and presenting with UHR/PEP EXCLUSION CRITERIA
- Motor disability
- intellectual disability,
- depression,
- insufficient French language proficiency,
- subject's refusal,
- currently undergoing cognitive remediation
EXCLUSION CRITERIA Physical injury, psychological decompensation, inpatient hospitalization Absence from a tennis or self-esteem group session does not constitute a criterion for exclusion. Regarding tennis, participation in at least 6 sessions is required for the data to be analyzable. Regarding self-esteem, any missed session will be made up in an individual format.
3 Procedures
: This is an open-label prospective study consisting of two unmatched parallel groups. Each group will consist of 4 experimental subjects and 4 control subjects.
Participants will undergo a pre-inclusion visit, during which the research project will be presented; then, during the inclusion visit (M0), informed consent, various sociodemographic data, medication information, and results from neuropsychological tests and scales will be collected. These include (estimated total duration 60-80 minutes):
- Rosenberg Self-Esteem Scale, commonly used in practice due to its short administration time (estimated 1-2 minutes) and psychometric properties; it consists of 10 statements regarding self-perception to be rated on a 4-point Likert scale ("strongly disagree," "somewhat disagree," "somewhat agree," "strongly agree") (Rosenberg, 1965; Vallieres \& Vallerand, 1990)
- 25-item Physical Self-Concept Inventory (ISP-25), assessing 5 dimensions, namely general self-esteem, perceived physical worth, physical fitness, athletic ability, physical appearance, and perceived strength using a 6-point Likert scale (ranging from "not at all" to "completely"); estimated duration 2-3 minutes (Ninot et al., 2000).
- Quality of Life Scale (WHOQOL-Bref), developed by the World Health Organization to assess general quality of life across four domains: physical health, social well-being, social relationships, and environment; rated on a 5-point Likert scale (ranging from "very poor" to "very good," "very dissatisfied/not at all satisfied" to "very satisfied," "not at all" to "extremely/completely/very much," or "never" to "always" depending on the item); estimated completion time of 2-3 minutes.
- Social Functioning Scale (QFS), developed for patients in psychiatric care and assessing, over the past 2 weeks, both the frequency of social behaviors and satisfaction with them, and demonstrating sensitivity to change; rated on a 5-point Likert scale (ranging from "every day" to "never" and from "very satisfied" to "very dissatisfied"); estimated time: 2-3 minutes.
- Negative Symptom Scale (SNS), validated in French, which uses a 3-point Likert scale ("strongly agree," "somewhat agree," "strongly disagree") 20 items covering social withdrawal, diminished emotional experience, alogia, avolition, and anhedonia; estimated duration 1-2 minutes.
- Self-Stigma Scale (ISMI) assessing, on a 4-point Likert scale (ranging from "strongly agree" to "strongly disagree"), 29 items leading to a total self-stigma score in individuals with a mental health disorder (estimated time: 2-3 minutes). Six subscores can be calculated, distinguishing between alienation, endorsement of stereotypes, experiences of discrimination, social withdrawal, and resistance to stigma.
- Commonly used neuropsychological tests with demonstrated psychometric qualities.
- RL/RI-16, assessing verbal memory through the learning of a list of 16 words in short-term memory and after a 20-minute delay (estimated duration 20-30 minutes); scoring of words recalled in immediate recall, 3 free recalls, and 3 total recalls according to established norms
- d2-R: assessment of attention via a 5-minute interference task; scoring of concentration ability, processing speed, and accuracy percentage according to established norms
- WAIS-IV Digit Span, assessing working memory via a span task in direct, indirect, and reverse orders, lasting 5 to 10 minutes; scoring of the total number of correct items according to established norms
- TMT A and B, assessing reactive flexibility via a dot-connecting task with alternating instructions, duration 2 to 3 minutes; scoring of time and errors according to established norms
- WAIS-IV codes, assessing processing speed via a graphomotor execution task, duration 2 minutes; scoring of the number of correct responses according to established norms
- Stroop, assessing inhibition via the "interference" sheet following the "naming" and "reading" control sheets, duration of 5 minutes; scoring of time and errors according to established norms
Participants will take part in 8 one-hour tennis sessions led by a certified instructor (the number of sessions will be determined in consultation with the instructor, taking into account the patients' specific needs), which will proceed as follows:
- Approximately 5-minute welcome period for participants
- Approximately 5-minute warm-up around the court
- Practice time: getting comfortable with the racket and first rallies in Session 1, adding forehand/backhand alternating drills in Session 2, adding serves and 1-on-1 rallies on half-court in Session 3, repeating the drills and increasing the complexity of the instructions for the remaining sessions
- Putting away equipment and restoring the clay court and/or a self-esteem group inspired by Tania Lecomte's "I'm Awesome!" module, consisting of 9 sessions of 1 hour and 30 minutes each, structured as follows:
- Watching a video introducing the concept of self-esteem (YouTube channel "Et tout le monde s'en fout")
- Work on the sense of security in sessions 1 and 2
- Working on a sense of identity in sessions 3 and 4
- Working on a sense of belonging in sessions 4 and 5
- Working on a sense of direction in sessions 6 and 7
- Working on a sense of competence in sessions 8
- Group conclusion and "Self-Esteem in 3D" dice game Finally, participants will undergo the same neuropsychological and psychometric assessment described earlier at the end of the study (M3). 4 Objectives Primary Objective To compare the subjective experiences in the social, academic/professional, clinical, and physical domains between a group participating in tennis combined with a self-esteem program and a group participating only in a self-esteem program Secondary Objectives
To compare a group participating in tennis combined with a self-esteem program with a group participating only in a self-esteem program:
- cognitive performance,
- overall self-esteem
- perceived physical value
- quality of life,
- social functioning,
- negative symptoms
- self-stigmatization
Evaluation criteria Primary outcome measure
- 10-point visual Likert scale (ranging from 0 "not at all well" to 10 "very well") to assess participants' feelings before and after the intervention in the social, academic/professional, clinical, and physical domains, as well as their qualitative comments ("How do you feel in the … domain?")
Secondary outcome measures
- Neuropsychological tests assessing: verbal memory (RL/RI-16), attention (d2-R), working memory (WAIS-IV Digit Span), flexibility (TMT A and B), processing speed (WAIS-IV Coding), and inhibition (Stroop Interference Task)
- Self-Esteem Scale (Rosenberg Scale),
- Physical Self-Concept Inventory (ISP-25)
- Quality of Life Scale (WHOQOL-Bref scale),
- Social Functioning Scale (QFS)
- Negative Symptom Scale (SNS),
- Self-Stigma Index (ISMI)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Tennis + Self esteem program | Experimental | Other: Tennis ( physical activity), Other: Self-esteem programParticipants in Group 1 took part in 8 tennis sessions and 6 self-esteem sessions. |
| Group 2: self-esteem program | Active comparator | Other: Self-esteem programParticipants in Group 2 only took part in 6 self-esteem sessions. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18 to 30 years diagnosed with at-risk mental state or first episode psychosis
Key exclusion criteria (6 listed)
- Motor disability
- intellectual disability,
- depression,
- insufficient French language proficiency,
- subject's refusal,
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 |
|---|---|---|
| Tennis ( physical activity)Eight tennis sessions, each lasting 1 hour and 15 minutes, led by a sports instructor specializing in tennis and a nurse case manager. The sessions took place at a tennis club. | Other | Group 1: Tennis + Self esteem program |
| Self-esteem programThe self-esteem program is called "I'm Great!" by Tania Lecomte et al., and has been validated in early intervention settings. 6 sessions. | Other | Group 1: Tennis + Self esteem program, Group 2: self-esteem program |
Primary outcome
Subjective experiences in the social, academic/professional, clinical, and physical domains, 10-point visual Likert scale
Time frame: 2 minutes
10-point visual Likert scale (ranging from 0 "not at all well" to 10 "very well") to assess participants' feelings before and after the intervention in the social, academic/professional, clinical, and physical domains, as well as their qualitative comments ("How do you feel in the … domain?"). A higher score means a better outcome.
12 secondary outcomes
Rappel Libre / Rappel Indicé - 16 (RL/RI-16).
Time frame: 15 minutes
d2-R
Time frame: 5 minutes
WAIS-IV Digit Span
Time frame: 5 to 10 minutes
Trail Marking Tests TMT A and B
Time frame: 2 minutes
WAIS-IV Coding
Time frame: 5 to 10 minutes
Stroop Interference Task
Time frame: 5 minutes
Rosenberg Scale
Time frame: 2 minutes
Physical Self-Concept Inventory (ISP-25)
Time frame: 2 to 3 minutes
WHOQOL-Bref scale
Time frame: 2 to 3 minutes
Social Functioning Scale (QFS)
Time frame: 2 to 3 minutes
Negative Symptom Scale (SNS)
Time frame: 1 to 2 minutes
Self-Stigma Index (ISMI)
Time frame: 2 to 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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. This study is not recruiting at the moment.
Mirvat Hamdan-Dumont, MD, PhD principal investigator
Centre Hospitalier Esquirol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tennis ( physical activity) and Self-esteem program in people with At-risk Mental States and First Episode Psychosis (FEP), run by Centre Hospitalier Esquirol 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective experiences in the social, academic/professional, clinical, and physical domains, 10-point visual Likert scale (time frame: 2 minutes). 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 8 Jun 2026.