Effectiveness of the RemedRugby Program

Study Overview
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Brief Summary
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REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an assertive way and to fight against stigma. It proposes to specifically target the processes of social cognition. Social cognition brings together the mental mechanisms that allow everyone to decipher the social situations, emotions and intentions of others and interact with others in the different contexts of everyday life. People with a psychic handicap frequently have difficulties in this area, which has often important consequences for their social and professional integration. The REMEDRUGBY program proposes to work specifically on these processes in the context of sport (+ role Play and blog) to strengthen the ability to interact with others and to deal with the stigma that can be encountered on a daily basis.

Official Title
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Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia

Conditions
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Schizophrenia, Social Cognition, Self Esteem, Empowerment, Recovery

Intervention / Treatment
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* Other: REMEDRUGBY PROGRAM
* Other: TOUCH RUGBY PROGRAM
* Other: TAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia, schizo-affective disorder (DSM-V criteria; APA, 2013). French mother tongue. psychotropic treatment unchanged during the month prior to inclusion. Patients who gave their informed consent to participate in the study. affiliated with a social security scheme or beneficiary of such a scheme Subject suitable for the practice of sport. Exclusion Criteria: Recent dependence and abuse on cannabis or any other substance (DSM-V criteria), except tobacco. Neurological disorders of vascular, infectious or neurodegenerative origin. taking of medicinal products with a cerebral or psychic impact (e.g., corticosteroids). Inability to practice sport Pregnancy planned or in progress Simultaneous Participation in any other program of remediation of social cognition, training in social skills, self-esteem.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RemedRugby program Vs TAU + TouchRugby
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REMEDRUGBY<br>TAU + RemedRugby Program | Other: REMEDRUGBY PROGRAM<br>* 1st Session presentation of the programme, its objectives and a common reflection on the concepts of stigmatization/destigmatization. 2nd to 4th session devoted to a group reflection on social conventions and their meaning followed by a practice by means of role-playing. 5th to 7th session devoted to writing comments about tournaments on the blog by working on the intentions of others and the emotional impact of comments on their recipients. 8th, 9th 11th sessions devoted to media relations with group reflection on the image of themselves and their pathology that participants wish to refer to the media, followed by a practice in role-playing games Interviewer-interviewed 10th session devoted to planning and organizing the day of matches with writing a program of the day and spreading on the blog 12th General Debriefing session Including : - 3 tournaments 8 hours of Touch Rugby<br>Other: TAU<br>* Treatment as usual<br>|
| Active Comparator: TAU + TOUCH RUGBY<br>TAU + Touch Rugby Program | Other: TOUCH RUGBY PROGRAM<br>* Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day<br>Other: TAU<br>* Treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movie to Assess Social Cognition (MASC) | Changes in the aggregates (average) of standardized performance levels : z-scores of Theory of Mind (range 0-45) during social cognitive remediation | Changes between baseline function, after intervention and at 6 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Symptoms Scale for Schizophrenia (PANSS) | Changes in the aggregates (average) of standardized performance levels : z-scores of positive and negative symptoms (minimum score 30- maximum score 210) of schizophrenia after social cognitive remediation | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Personal and Social Performance scale (PSP) | Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after social cognitive remediation | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Self Esteem Rating Scale (SERS) | Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Boston University Empowerment Scale (BUES) | Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1- maximum score 4) in self-assessment of empowerment | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Internalized Stigma of Mental Illness (ISMI) | self-assessment of internalized stigma | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Stages of Recovery Instrument (STORI) | Self-assessment of personal recovery | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Social Perception and Knowledge (PerSo) | cognitive task to assess competence in perception of social situations and social knowledge | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Ambiguous Intentions and Hostility Questionnaire (AIHQ) | Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1, maximum score 6) at a cognitive task to measure hostile social cognitive bias | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Questionnaire of Cognitive and Affective Empathy | Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 31, maximum score 124) in a self-assessment of empathy | Changes between baseline function, after intervention and at 6 months of follow-up | 
| French National Adult Reading Test (f-NART | cognitive task to assess premorbid intellectual quotient (IQ) | Baseline measure only | 
| Trail Making Test A (TMT A) | cognitive task to assess speed of processing | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Trail Making Test B (TMT B) | cognitive task to assess reactive mental flexibility | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Self-assessment of Social Cognition (AcSo) | self-assessment of patient' perception of social cognitive deficits | Changes between baseline function, after intervention and at 6 months of follow-up | 
| Commission Test (modified zoo test) | cognitive task to asess planification abilities | Changes between baseline function, after intervention and at 6 months of follow-up |