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Effectiveness of the RemedRugby Program

Sponsor
Hospital Center Alpes-Isère (Other)
Overall Status
Completed
CT.gov ID
NCT03775564
Collaborator
Centre Hospitalier Le Valmont (Valence) (Other), Hôpital le Vinatier (Other), Centre Hospitalier Spécialisé de la Savoie (Chambéry) (Other), Centre Hospitalier Annecy Genevois (Other), Centre Hospitalier Universitaire de Saint Etienne (Other), Centre Hospitalier Sainte Marie de Clermont Ferrand (Other), University Hospital, Clermont-Ferrand (Other)
60
Enrollment
8
Locations
2
Arms
49
Actual Duration (Months)
7.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: REMEDRUGBY PROGRAM
  • Other: TOUCH RUGBY PROGRAM
  • Other: TAU
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RemedRugby program Vs TAU + TouchRugbyRemedRugby 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 :
Nov 1, 2014
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Movie to Assess Social Cognition (MASC) [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) [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) [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) [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) [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) [Changes between baseline function, after intervention and at 6 months of follow-up]

    self-assessment of internalized stigma

  6. Stages of Recovery Instrument (STORI) [Changes between baseline function, after intervention and at 6 months of follow-up]

    Self-assessment of personal recovery

  7. Social Perception and Knowledge (PerSo) [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) [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 [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 [Baseline measure only]

    cognitive task to assess premorbid intellectual quotient (IQ)

  11. Trail Making Test A (TMT A) [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) [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) [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) [Changes between baseline function, after intervention and at 6 months of follow-up]

    cognitive task to asess planification abilities

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ch Annecy-Genevois Annecy Aura France 74000
2 Ch Le Vinatier Bron Aura France 69678
3 Chs de La Savoie Chambéry Aura France 73000
4 Ch Sainte-Marie Clermont-Ferrand Aura France 63000
5 CHU de CLERMONT-FERRAND Clermont-Ferrand Aura France 63000
6 HCAlpesIsere Saint-Égrève Aura France 38120
7 Chu Saint-Etienne Saint-Étienne Aura France 42000
8 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

  • Principal Investigator: Julien JD DUBREUCQ, MD, Hospital Center Alpes-Isère

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr Julien Dubreucq, Medical Doctor, Hospital Center Alpes-Isère
ClinicalTrials.gov Identifier:
NCT03775564
Other Study ID Numbers:
  • 2014-A01612-45
First Posted:
Dec 14, 2018
Last Update Posted:
Mar 15, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Schizophrenia

Study Results

No Results Posted as of Mar 15, 2019