- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07633899
The Influence of Tennis in Early Intervention (ITIP)
The Influence of Tennis in Early Intervention (ITIP): a Pilot Study
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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)
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Limoges, Francia, 87025
- Centre Hospitalier Esquirol
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
Patients aged 18 to 30 years diagnosed with at-risk mental state or first episode psychosis
Exclusion Criteria:
- Motor disability
- intellectual disability,
- depression,
- insufficient French language proficiency,
- subject's refusal,
- currently undergoing cognitive remediation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Group 1: Tennis + Self esteem program
Participants in Group 1 took part in 8 tennis sessions and 6 self-esteem sessions.
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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.
The self-esteem program is called "I'm Great!" by Tania Lecomte et al., and has been validated in early intervention settings.
6 sessions.
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Comparatore attivo: Group 2: self-esteem program
Participants in Group 2 only took part in 6 self-esteem sessions.
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The self-esteem program is called "I'm Great!" by Tania Lecomte et al., and has been validated in early intervention settings.
6 sessions.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Subjective experiences in the social, academic/professional, clinical, and physical domains, 10-point visual Likert scale
Lasso di tempo: 2 minutes
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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.
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2 minutes
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rappel Libre / Rappel Indicé - 16 (RL/RI-16).
Lasso di tempo: 15 minutes
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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. |
15 minutes
|
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d2-R
Lasso di tempo: 5 minutes
|
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. |
5 minutes
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WAIS-IV Digit Span
Lasso di tempo: 5 to 10 minutes
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A neuropsychological subtest that assesses attention, working memory, and mental manipulation by requiring the repetition of number sequences. Minimum score 0, maximum score 48. |
5 to 10 minutes
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Trail Marking Tests TMT A and B
Lasso di tempo: 2 minutes
|
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. |
2 minutes
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WAIS-IV Coding
Lasso di tempo: 5 to 10 minutes
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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 |
5 to 10 minutes
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Stroop Interference Task
Lasso di tempo: 5 minutes
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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. |
5 minutes
|
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Rosenberg Scale
Lasso di tempo: 2 minutes
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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. |
2 minutes
|
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Physical Self-Concept Inventory (ISP-25)
Lasso di tempo: 2 to 3 minutes
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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.
|
2 to 3 minutes
|
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WHOQOL-Bref scale
Lasso di tempo: 2 to 3 minutes
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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.
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2 to 3 minutes
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Social Functioning Scale (QFS)
Lasso di tempo: 2 to 3 minutes
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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. |
2 to 3 minutes
|
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Negative Symptom Scale (SNS)
Lasso di tempo: 1 to 2 minutes
|
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. |
1 to 2 minutes
|
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Self-Stigma Index (ISMI)
Lasso di tempo: 2 to 3 minutes
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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. |
2 to 3 minutes
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mirvat Hamdan-Dumont, MD, PhD, Centre Hospitalier Esquirol
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2022-A01406-37
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