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Effectiveness of the RemedRugby Program (RemedRugby)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775564
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
Centre Hospitalier Le Valmont (Valence)
Hôpital le Vinatier
Centre Hospitalier Spécialisé de la Savoie (Chambéry)
Centre Hospitalier Annecy Genevois
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Sainte Marie de Clermont Ferrand
University Hospital, Clermont-Ferrand
Information provided by (Responsible Party):
Dr Julien Dubreucq, Hospital Center Alpes-Isère

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Social Cognition Self Esteem Empowerment Recovery Other: REMEDRUGBY PROGRAM Other: TOUCH RUGBY PROGRAM Other: TAU Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RemedRugby program Vs TAU + TouchRugby
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia
Actual Study Start Date : November 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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: 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

Other: TAU
Treatment as usual




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775564


Locations
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France
Ch Annecy-Genevois
Annecy, Aura, France, 74000
Ch Le Vinatier
Bron, Aura, France, 69678
Chs de La Savoie
Chambéry, Aura, France, 73000
Ch Sainte-Marie
Clermont-Ferrand, Aura, France, 63000
CHU de CLERMONT-FERRAND
Clermont-Ferrand, Aura, France, 63000
HCAlpesIsere
Saint-Égrève, Aura, France, 38120
Chu Saint-Etienne
Saint-Étienne, Aura, France, 42000
Chs Le Valmont
Valence, Aura, France, 26000
Sponsors and Collaborators
Hospital Center Alpes-Isère
Centre Hospitalier Le Valmont (Valence)
Hôpital le Vinatier
Centre Hospitalier Spécialisé de la Savoie (Chambéry)
Centre Hospitalier Annecy Genevois
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Sainte Marie de Clermont Ferrand
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Julien JD DUBREUCQ, MD Hospital Center Alpes-Isère
Publications:

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Responsible Party: Dr Julien Dubreucq, Medical Doctor, Hospital Center Alpes-Isère
ClinicalTrials.gov Identifier: NCT03775564    
Other Study ID Numbers: 2014-A01612-45
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders