Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia

NCT02110771 | Completed

• 1 other identifier: 2011-A00793-38
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Social cognition impairments was highlighted for persons suffering with schizophrenia by numerous studies. The use of treatment programs intended to treat specifically these deficits through procedures of cognitive remediation, will allow decreasing their impact on everyday life by improving abilities to understand and interact with others. Such tools could allow also profits in terms of reduction of positive and negative of schizophrenia. The Gaïa program is intended to improve the perception of the facial affects which is one of social cognition processes impaired in schizophrenia. Methods: This is a multicenter, randomized, controlled study comparing people aged 18 to 45 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manuel of Mental disorders, 4th edition (DSM-IV-TR). The GAÏA program will be compared to an already validated neurocognitive remediation program, training attentional processes (RECOS). 100 patients will be randomized as follows: Arm 1, experimental: Gaïa (20h with therapist, computer assisted method) Arm 2, control: RECOS (20h with therapist, computer assisted method) Condition: Schizophrenia Intervention: Behavioural: computer assisted cognitive remediation Hypothesis: A targeted cognitive remediation will more increased abilities in facial affects recognition processes than a non specific, attentional cognitive remediation. Primary outcome measures: \- Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after 10 weeks and 20 session of treatment. Secondary outcome measures

• Change from baseline in clinical, psychosocial, social cognition and neurocognitive measures, after 10 weeks and 20 session of treatment and at 6 months follow-up.
• Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after treatment and 6 months follow-up.

Conditions

Schizophrenia

Keywords

schizophrenia; social cognition; facial affects recognition; cognitive remediation

Outcome Measures

Primary Outcomes (1)

• Facial Emotions Recognition Task(TREF)

  The TREF presents 54 photos representing 6 basic emotions (joy, anger, sadness, fear, disgust and contempt). Each emotion is presented with 9 intensity levels (from 20% to 100%),and by 4 models (2 mens and 2 womens) Subject has to select his answer in a list of 6 items (joy, anger, sadness, fear, disgust and contempt), each photo is presented during 10 seconds maximum, there's no time limit to answer.

  week 11

Secondary Outcomes (8)

• TREF (Facial emotions recognition task)

  6 month follow up

• Change from baseline in symptoms measure 1

  week 11 and 6 month follow-up

• Change from baseline in social cognition measures

  week 11 and 6 month follow-up

• Change from baseline in neurocognitive functioning measures

  week 11and 6 month follow-up

• Change from baseline in symptoms measure 2

  week 11 and 6 month follow-up

Study Arms (2)

GAÏA - facial affect recognition targeted

EXPERIMENTAL

GAÏA:20hours individual cognitive remediation with therapist, 10 tasks at home, 10 week-treatment cognitive remediation targeted on facial affects recognition. exercises were designed by Gaudelus and Franck (2012) and tutoractiv'company. It includes photos, computer and role games exercises.Computer based exercises have 5 difficulty levels. 2 sessions of one hour per week with therapist. Tasks at home are given once a week and targeting functional outcomes associated with facial affects recognition impairment.

Behavioral: GAÏA - facial affect recognition targeted

RECOS - attentional process targeted

ACTIVE COMPARATOR

RECOS (Cognitive REmediation for Schizophrenia): 20 hours individual cognitive remediation with therapist, 10 tasks at home, 10 week-treatment. RECOS is a validated cognitive remediation program, developed by P. Vianin and SBT company. It includes paper and pen and computer based exercises. The original program proposes 5 modules targeting 5 cognitive functions, each patient participated in the module corresponding to his/her most altered cognitive function. In this study, all patients randomized in this arm are allocated in the attentional module.Every computer exercises have 10 difficulty levels. 2 sessions of one hour per week with therapist. Tasks at home are given once a week and targeting functional outcome

Behavioral: RECOS - attentional process targeted

Interventions

GAÏA - facial affect recognition targeted BEHAVIORAL

2 sessions of one hour per week with therapist. Intervention proposes 3 stages : 1)discovering and learning facial affects recognition and discrimination criterions for joy, sadness and anger (photos exercises); 2) facial affect recognition training (computer based and role game exercises); 3) generalization to other emotions (photos, role games and computer based exercises). The therapist chooses the change of stages; 5 sessions or more are proposed for the generalization stage.

GAÏA - facial affect recognition targeted

RECOS - attentional process targeted BEHAVIORAL

2 sessions of one hour per week with therapist the first of those two session is allocated to paper and pen exercises (search and validation of strategies to resolve cognitive training exercises or functional problems). the second session is allocated to computer based exercises.

RECOS - attentional process targeted

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 to 45 years
• French speaker
• Clinical stability
• Diagnosis of schizophrenia according to the DSM-IV-TR
• Agreement of the guardian for the patients under guardianship
• Overdrawn performances in the treatment of the facial information
• Patients having given their consent lit to participate in the study

You may not qualify if:

• alcohol or drug dependence (according to the DSM-IV-TR), except tobacco
• history of neurobiological illness or trauma
• the ineffectiveness of neuroleptic treatment
• Taking of medicine with somatic aim having a cerebral or psychic impact
• Simultaneous participation on an other program of cognitive remediation

Sponsors & Collaborators

• Hôpital le Vinatier: lead
• Hospital Center Alpes-Isère: collaborator
• Centre Hospitalier St Anne: collaborator
• Centre Hospitalier Intercommunal Clermont de l'Oise: collaborator

Study Sites (1)

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, 69006, France

Location

Related Publications (15)

• Vianin P.Cognitive Remediation for schizophrenia. Presentation of the RECOS program.Anales Medico psychologiques 165: 200-205, 2007

  BACKGROUND

• Franck N, Duboc C, Sundby C, Amado I, Wykes T, Demily C, Launay C, Le Roy V, Bloch P, Willard D, Todd A, Petitjean F, Foullu S, Briant P, Grillon ML, Deppen P, Verdoux H, Bralet MC, Januel D, Riche B, Roy P; Other members of the Cognitive Remediation Network; Vianin P. Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophr Res. 2013 Jun;147(1):68-74. doi: 10.1016/j.schres.2013.03.009. Epub 2013 Apr 9.

  PMID: 23583327 BACKGROUND

• Gaudelus B, Franck N. Troubles du traitement des informations faciales. Le programme GAÏA. In Franck N, editor.La remédiation cognitive. Paris: Eselvier Masson: 169-81,2012.

  BACKGROUND

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  PMID: 7908156 BACKGROUND

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  BACKGROUND

• Bazin N, Brunet-Gouet E, Bourdet C, Kayser N, Falissard B, Hardy-Bayle MC, Passerieux C. Quantitative assessment of attribution of intentions to others in schizophrenia using an ecological video-based task: a comparison with manic and depressed patients. Psychiatry Res. 2009 May 15;167(1-2):28-35. doi: 10.1016/j.psychres.2007.12.010. Epub 2009 Apr 5.

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  PMID: 12232540 BACKGROUND

• Gaudelus B, Virgile J, Peyroux E, Leleu A, Baudouin JY, Franck N. [Measuring impairment of facial affects recognition in schizophrenia. Preliminary study of the facial emotions recognition task (TREF)]. Encephale. 2015 Jun;41(3):251-9. doi: 10.1016/j.encep.2014.08.013. Epub 2014 Sep 17. French.

  PMID: 25240938 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Franck Nicolas, PUPH

  Hôpital le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: April 10, 2014
• Study Start: May 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2015-09

Locations

FR (1)