Effectiveness of the RemedRugby Program (RemedRugby)

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Recovery; Social Cognition; Self Esteem; Empowerment
• Intervention / Treatment: Other: REMEDRUGBY PROGRAM; Other: TAU; Other: TOUCH RUGBY PROGRAM

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aura
    • Annecy, Aura, France, 74000
      • CH Annecy-Genevois
    • Bron, Aura, France, 69678
      • CH Le Vinatier
    • Chambéry, Aura, France, 73000
      • CHS de la Savoie
    • Clermont-Ferrand, Aura, France, 63000
      • Ch Sainte-Marie
    • Clermont-Ferrand, Aura, France, 63000
      • CHU de Clermont-Ferrand
    • Saint-Égrève, Aura, France, 38120
      • HCAlpesIsere
    • Saint-Étienne, Aura, France, 42000
      • CHU Saint-Etienne
    • Valence, Aura, France, 26000
      • Chs Le Valmont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REMEDRUGBY; TAU + RemedRugby Program	Other: REMEDRUGBY PROGRAM; 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; Other: TAU; Treatment as usual
Active Comparator: TAU + TOUCH RUGBY; TAU + Touch Rugby Program	Other: TAU; Treatment as usual; Other: TOUCH RUGBY PROGRAM; Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Center Alpes-Isère
• Collaborators: Centre Hospitalier Universitaire de Saint Etienne; University Hospital, Clermont-Ferrand; Hôpital le Vinatier; Centre Hospitalier Annecy Genevois; Centre Hospitalier Le Valmont (Valence); Centre Hospitalier Spécialisé de la Savoie (Chambéry); Centre Hospitalier Sainte Marie de Clermont Ferrand

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 2014-A01612-45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No