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Completed

NCT Number: NCT03775564

Effectiveness of the RemedRugby Program

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.

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Key information

Conditions

Schizophrenia Behavior Empowerment Mental Disorders Recovery Schizophrenia Spectrum and Other Psychotic Disorders Self Esteem Social Behavior Social Cognition

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Annecy-Genevois, Annecy, AURA, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Other

Treatment as usual

Primary outcomes

  1. Movie to Assess Social Cognition (MASC)

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

    Changes in the aggregates (average) of standardized performance levels : z-scores of Theory of Mind (range 0-45) during social cognitive remediation

Secondary outcomes

  1. Positive and Negative Symptoms Scale for Schizophrenia (PANSS)

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

    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

  2. Personal and Social Performance scale (PSP)

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

    Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after social cognitive remediation

  3. Self Esteem Rating Scale (SERS)

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

    Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem

  4. Boston University Empowerment Scale (BUES)

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

    Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1- maximum score 4) in self-assessment of empowerment

  5. Internalized Stigma of Mental Illness (ISMI)

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

    self-assessment of internalized stigma

  6. Stages of Recovery Instrument (STORI)

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

    Self-assessment of personal recovery

  7. Social Perception and Knowledge (PerSo)

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

    cognitive task to assess competence in perception of social situations and social knowledge

  8. Ambiguous Intentions and Hostility Questionnaire (AIHQ)

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

    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

  9. Questionnaire of Cognitive and Affective Empathy

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

    Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 31, maximum score 124) in a self-assessment of empathy

  10. French National Adult Reading Test (f-NART

    Time frame: Baseline measure only

    cognitive task to assess premorbid intellectual quotient (IQ)

  11. Trail Making Test A (TMT A)

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

    cognitive task to assess speed of processing

  12. Trail Making Test B (TMT B)

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

    cognitive task to assess reactive mental flexibility

  13. Self-assessment of Social Cognition (AcSo)

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

    self-assessment of patient' perception of social cognitive deficits

  14. Commission Test (modified zoo test)

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

    cognitive task to asess planification abilities

Sponsors and collaborators

Lead sponsor

Hospital Center Alpes-Isère

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: RemedRugby

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2018
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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