Effectiveness of the RemedRugby Program

NCT03775564 | Completed

• 1 other identifier: 2014-A01612-45
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Schizophrenia; Social Cognition; Self Esteem; Empowerment; Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Positive and Negative Symptoms Scale for Schizophrenia (PANSS)

  Changes between baseline function, after intervention and at 6 months of follow-up

• Personal and Social Performance scale (PSP)

  Changes between baseline function, after intervention and at 6 months of follow-up

• Self Esteem Rating Scale (SERS)

  Changes between baseline function, after intervention and at 6 months of follow-up

• Boston University Empowerment Scale (BUES)

  Changes between baseline function, after intervention and at 6 months of follow-up

• Internalized Stigma of Mental Illness (ISMI)

  Changes between baseline function, after intervention and at 6 months of follow-up

Study Arms (2)

REMEDRUGBY

EXPERIMENTAL

TAU + RemedRugby Program

Other: REMEDRUGBY PROGRAM; Other: TAU

TAU + TOUCH RUGBY

ACTIVE COMPARATOR

TAU + Touch Rugby Program

Other: TOUCH RUGBY PROGRAM; Other: TAU

Interventions

REMEDRUGBY PROGRAM OTHER

* 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

REMEDRUGBY

TOUCH RUGBY PROGRAM OTHER

Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day

TAU + TOUCH RUGBY

TAU OTHER

Treatment as usual

REMEDRUGBY; TAU + TOUCH RUGBY

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia, schizo-affective disorder (DSM-V criteria; APA, 2013).
• French mother tongue.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (8)

Ch Annecy-Genevois

Annecy, AURA, 74000, France

Location

Ch Le Vinatier

Bron, Aura, 69678, France

Location

Chs de La Savoie

Chambéry, AURA, 73000, France

Location

Ch Sainte-Marie

Clermont-Ferrand, AURA, 63000, France

Location

CHU de CLERMONT-FERRAND

Clermont-Ferrand, AURA, 63000, France

Location

Chu Saint-Etienne

Saint-Etienne, AURA, 42000, France

Location

HCAlpesIsere

Saint-Égrève, AURA, 38120, France

Location

Chs Le Valmont

Valence, AURA, 26000, France

Location

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MeSH Terms

Conditions

Schizophrenia; Empowerment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Julien JD DUBREUCQ, MD

  Hospital Center Alpes-Isère

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: RemedRugby program Vs TAU + TouchRugby

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: December 14, 2018
• Study Start: November 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

FR (8)