Effectiveness of the RemedRugby Program

Schizophrenia Clinical Trial

— RemedRugby  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775564
• Other study ID #: 2014-A01612-45
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Hospital Center Alpes-Isère
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Empowerment
• Recovery
• Schizophrenia
• Self Esteem
• Social Cognition

Intervention

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
• 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
• TAU
Treatment as usual

Locations

Country	Name	City	State
France	Ch Annecy-Genevois	Annecy	Aura
France	Ch Le Vinatier	Bron	Aura
France	Chs de La Savoie	Chambéry	Aura
France	Ch Sainte-Marie	Clermont-Ferrand	Aura
France	CHU de CLERMONT-FERRAND	Clermont-Ferrand	Aura
France	HCAlpesIsere	Saint-Égrève	Aura
France	Chu Saint-Etienne	Saint-Étienne	Aura
France	Chs Le Valmont	Valence	Aura

Sponsors (8)

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

Country where clinical trial is conducted

France, 

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* Note: There are 63 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Internalized Stigma of Mental Illness (ISMI)	self-assessment of internalized stigma	Changes between baseline function, after intervention and at 6 months of follow-up
Secondary	Stages of Recovery Instrument (STORI)	Self-assessment of personal recovery	Changes between baseline function, after intervention and at 6 months of follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	French National Adult Reading Test (f-NART	cognitive task to assess premorbid intellectual quotient (IQ)	Baseline measure only
Secondary	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
Secondary	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
Secondary	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
Secondary	Commission Test (modified zoo test)	cognitive task to asess planification abilities	Changes between baseline function, after intervention and at 6 months of follow-up