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Effectiveness of the RemedRugby Program (RemedRugby)

Primary Purpose

Schizophrenia, Social Cognition, Self Esteem

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
REMEDRUGBY PROGRAM
TOUCH RUGBY PROGRAM
TAU
Sponsored by
Hospital Center Alpes-Isère
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ch Annecy-Genevois
  • Ch Le Vinatier
  • Chs de La Savoie
  • Ch Sainte-Marie
  • CHU de CLERMONT-FERRAND
  • HCAlpesIsere
  • Chu Saint-Etienne
  • Chs Le Valmont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REMEDRUGBY

TAU + TOUCH RUGBY

Arm Description

TAU + RemedRugby Program

TAU + Touch Rugby Program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
Internalized Stigma of Mental Illness (ISMI)
self-assessment of internalized stigma
Stages of Recovery Instrument (STORI)
Self-assessment of personal recovery
Social Perception and Knowledge (PerSo)
cognitive task to assess competence in perception of social situations and social knowledge
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
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
French National Adult Reading Test (f-NART
cognitive task to assess premorbid intellectual quotient (IQ)
Trail Making Test A (TMT A)
cognitive task to assess speed of processing
Trail Making Test B (TMT B)
cognitive task to assess reactive mental flexibility
Self-assessment of Social Cognition (AcSo)
self-assessment of patient' perception of social cognitive deficits
Commission Test (modified zoo test)
cognitive task to asess planification abilities

Full Information

First Posted
July 27, 2018
Last Updated
March 14, 2019
Sponsor
Hospital Center Alpes-Isère
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
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1. Study Identification

Unique Protocol Identification Number
NCT03775564
Brief Title
Effectiveness of the RemedRugby Program
Acronym
RemedRugby
Official Title
Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Center Alpes-Isère
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Social Cognition, Self Esteem, Empowerment, Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RemedRugby program Vs TAU + TouchRugby
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REMEDRUGBY
Arm Type
Experimental
Arm Description
TAU + RemedRugby Program
Arm Title
TAU + TOUCH RUGBY
Arm Type
Active Comparator
Arm Description
TAU + Touch Rugby Program
Intervention Type
Other
Intervention Name(s)
REMEDRUGBY PROGRAM
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
TOUCH RUGBY PROGRAM
Intervention Description
Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day
Intervention Type
Other
Intervention Name(s)
TAU
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
Movie to Assess Social Cognition (MASC)
Description
Changes in the aggregates (average) of standardized performance levels : z-scores of Theory of Mind (range 0-45) during social cognitive remediation
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Secondary Outcome Measure Information:
Title
Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
Description
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
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Personal and Social Performance scale (PSP)
Description
Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after social cognitive remediation
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Self Esteem Rating Scale (SERS)
Description
Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Boston University Empowerment Scale (BUES)
Description
Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1- maximum score 4) in self-assessment of empowerment
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Internalized Stigma of Mental Illness (ISMI)
Description
self-assessment of internalized stigma
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Stages of Recovery Instrument (STORI)
Description
Self-assessment of personal recovery
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Social Perception and Knowledge (PerSo)
Description
cognitive task to assess competence in perception of social situations and social knowledge
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Ambiguous Intentions and Hostility Questionnaire (AIHQ)
Description
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
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Questionnaire of Cognitive and Affective Empathy
Description
Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 31, maximum score 124) in a self-assessment of empathy
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
French National Adult Reading Test (f-NART
Description
cognitive task to assess premorbid intellectual quotient (IQ)
Time Frame
Baseline measure only
Title
Trail Making Test A (TMT A)
Description
cognitive task to assess speed of processing
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Trail Making Test B (TMT B)
Description
cognitive task to assess reactive mental flexibility
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Self-assessment of Social Cognition (AcSo)
Description
self-assessment of patient' perception of social cognitive deficits
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up
Title
Commission Test (modified zoo test)
Description
cognitive task to asess planification abilities
Time Frame
Changes between baseline function, after intervention and at 6 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien JD DUBREUCQ, MD
Organizational Affiliation
Hospital Center Alpes-Isère
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Annecy-Genevois
City
Annecy
State/Province
Aura
ZIP/Postal Code
74000
Country
France
Facility Name
Ch Le Vinatier
City
Bron
State/Province
Aura
ZIP/Postal Code
69678
Country
France
Facility Name
Chs de La Savoie
City
Chambéry
State/Province
Aura
ZIP/Postal Code
73000
Country
France
Facility Name
Ch Sainte-Marie
City
Clermont-Ferrand
State/Province
Aura
ZIP/Postal Code
63000
Country
France
Facility Name
CHU de CLERMONT-FERRAND
City
Clermont-Ferrand
State/Province
Aura
ZIP/Postal Code
63000
Country
France
Facility Name
HCAlpesIsere
City
Saint-Égrève
State/Province
Aura
ZIP/Postal Code
38120
Country
France
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
State/Province
Aura
ZIP/Postal Code
42000
Country
France
Facility Name
Chs Le Valmont
City
Valence
State/Province
Aura
ZIP/Postal Code
26000
Country
France

12. IPD Sharing Statement

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