Clinical trial NCT03775564: Effectiveness of the RemedRugby Program
Official title: Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Social Cognition
Self Esteem
Empowerment
Recovery
Lead sponsor: Hospital Center Alpes-Isère
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Le Valmont (Valence)
name: Hôpital le Vinatier
name: Centre Hospitalier Spécialisé de la Savoie (Chambéry)
name: Centre Hospitalier Annecy Genevois
name: Centre Hospitalier Universitaire de Saint Etienne
name: Centre Hospitalier Sainte Marie de Clermont Ferrand
name: University Hospital, Clermont-Ferrand
First posted: 2018-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RemedRugby program Vs TAU + TouchRugby
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Movie to Assess Social Cognition (MASC)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
Secondary outcomes:
measure: Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Personal and Social Performance scale (PSP)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Self Esteem Rating Scale (SERS)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Boston University Empowerment Scale (BUES)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Internalized Stigma of Mental Illness (ISMI)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Stages of Recovery Instrument (STORI)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Social Perception and Knowledge (PerSo)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Ambiguous Intentions and Hostility Questionnaire (AIHQ)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Questionnaire of Cognitive and Affective Empathy
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: French National Adult Reading Test (f-NART
timeFrame: Baseline measure only
measure: Trail Making Test A (TMT A)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Trail Making Test B (TMT B)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Self-assessment of Social Cognition (AcSo)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
measure: Commission Test (modified zoo test)
timeFrame: Changes between baseline function, after intervention and at 6 months of follow-up
Other outcomes:
Locations:
city: Annecy
country: France
facility: Ch Annecy-Genevois
state: Aura
city: Bron
country: France
facility: Ch Le Vinatier
state: Aura
city: Chambéry
country: France
facility: Chs de La Savoie
state: Aura
city: Clermont-Ferrand
country: France
facility: Ch Sainte-Marie
state: Aura
city: Clermont-Ferrand
country: France
facility: CHU de CLERMONT-FERRAND
state: Aura
city: Saint-Égrève
country: France
facility: HCAlpesIsere
state: Aura
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
state: Aura
city: Valence
country: France
facility: Chs Le Valmont
state: Aura
Study officials:
affiliation: Hospital Center Alpes-Isère
name: Julien JD DUBREUCQ, MD
role: PRINCIPAL_INVESTIGATOR
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