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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03775564
Other study ID # 2014-A01612-45
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date December 2018

Study information

Verified date March 2019
Source Hospital Center Alpes-Isère
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Intervention

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
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
TAU
Treatment as usual

Locations

Country Name City State
France Ch Annecy-Genevois Annecy Aura
France Ch Le Vinatier Bron Aura
France Chs de La Savoie Chambéry Aura
France Ch Sainte-Marie Clermont-Ferrand Aura
France CHU de CLERMONT-FERRAND Clermont-Ferrand Aura
France HCAlpesIsere Saint-Égrève Aura
France Chu Saint-Etienne Saint-Étienne Aura
France Chs Le Valmont Valence Aura

Sponsors (8)

Lead Sponsor Collaborator
Hospital Center Alpes-Isère 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

Country where clinical trial is conducted

France, 

References & Publications (63)

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* Note: There are 63 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes between baseline function, after intervention and at 6 months of follow-up
Secondary 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 Changes between baseline function, after intervention and at 6 months of follow-up
Secondary 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 Changes between baseline function, after intervention and at 6 months of follow-up
Secondary 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 Changes between baseline function, after intervention and at 6 months of follow-up
Secondary 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 Changes between baseline function, after intervention and at 6 months of follow-up
Secondary Internalized Stigma of Mental Illness (ISMI) self-assessment of internalized stigma Changes between baseline function, after intervention and at 6 months of follow-up
Secondary Stages of Recovery Instrument (STORI) Self-assessment of personal recovery Changes between baseline function, after intervention and at 6 months of follow-up
Secondary Social Perception and Knowledge (PerSo) cognitive task to assess competence in perception of social situations and social knowledge Changes between baseline function, after intervention and at 6 months of follow-up
Secondary 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 Changes between baseline function, after intervention and at 6 months of follow-up
Secondary 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 Changes between baseline function, after intervention and at 6 months of follow-up
Secondary French National Adult Reading Test (f-NART cognitive task to assess premorbid intellectual quotient (IQ) Baseline measure only
Secondary Trail Making Test A (TMT A) cognitive task to assess speed of processing Changes between baseline function, after intervention and at 6 months of follow-up
Secondary Trail Making Test B (TMT B) cognitive task to assess reactive mental flexibility Changes between baseline function, after intervention and at 6 months of follow-up
Secondary Self-assessment of Social Cognition (AcSo) self-assessment of patient' perception of social cognitive deficits Changes between baseline function, after intervention and at 6 months of follow-up
Secondary Commission Test (modified zoo test) cognitive task to asess planification abilities Changes between baseline function, after intervention and at 6 months of follow-up
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