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

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ClinicalTrials.gov Identifier: NCT02110771
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : March 3, 2016
Sponsor:
Collaborators:
Hospital Center Alpes-Isère
Centre Hospitalier St Anne
Centre Hospitalier Intercommunal Clermont de l'Oise
Information provided by (Responsible Party):
Hôpital le Vinatier

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: GAÏA - facial affect recognition targeted Behavioral: RECOS - attentional process targeted Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia
Study Start Date : May 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: GAÏA - facial affect recognition targeted

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

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.


Active Comparator: RECOS - attentional process targeted

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
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.




Primary Outcome Measures :
  1. Facial Emotions Recognition Task(TREF) [ Time Frame: week 11 ]
    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.


Secondary Outcome Measures :
  1. TREF (Facial emotions recognition task) [ Time Frame: 6 month follow up ]
  2. Change from baseline in symptoms measure 1 [ Time Frame: week 11 and 6 month follow-up ]
    PANSS - Positive and negative symptoms scale. global score, positive sub scale score and negative sub scale score

  3. Change from baseline in social cognition measures [ Time Frame: week 11 and 6 month follow-up ]
    Tasks for social cognitive measurement: Hinting task - Theory of mind ; LIS-V - Theory of mind - intentional reading in situation; Eyes Test - Theory of mind ; AIHQ- Attribution Style ; Ambiguous Intentions Hostility Questionary ; LEAS- Levels of Emotional Awareness Scale; QCAE- Questionnaire of Cognitive and Affective Empathy

  4. Change from baseline in neurocognitive functioning measures [ Time Frame: week 11and 6 month follow-up ]
    Tasks for neurocognitive functioning measurement attentional functions: D2; TAP. Executive functions:TMT- Trail making test ; BADS/search keys score ; Rey figure. Working memory: memory span ; Corsi blocs ;BVMT-R. Processing speed: WAIS-IV - Code and Symbol score. Perceptive functions: VOT.

  5. Change from baseline in symptoms measure 2 [ Time Frame: week 11 and 6 month follow-up ]
    PDI 21- Peters and al. Delusions Inventory 21 items Global score

  6. Change from baseline in insight measure [ Time Frame: week 11 and 6 month follow-up ]
    Birchwood insight scale. Global score

  7. Change from baseline in self estime measure [ Time Frame: week 11 and 6 month follow up ]
    SERS -Self-Esteem Rating Scale. Global score

  8. Change from baseline in social functioning measure [ Time Frame: week 11 and 6 month follow-up ]
    EAS -Social Autonomy Scale. Global score and relationship with others score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Unchanged psychotropic treatment during month preceding the inclusion
  • Overdrawn performances in the treatment of the facial information
  • Patients having given their consent lit to participate in the study

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110771


Locations
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France
centre de réhabilitation - Hôpital le Vinatier
Lyon, Rhône, France, 69006
Sponsors and Collaborators
Hôpital le Vinatier
Hospital Center Alpes-Isère
Centre Hospitalier St Anne
Centre Hospitalier Intercommunal Clermont de l'Oise
Investigators
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Principal Investigator: Franck Nicolas, PUPH Hôpital le Vinatier
Publications:
Vianin P.Cognitive Remediation for schizophrenia. Presentation of the RECOS program.Anales Medico psychologiques 165: 200-205, 2007
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.
Corcoran R, Frith CD. Thematic reasoning and theory of mind. Accounting for social inference difficulties in schizophrenia. Evolutionary Psychology 3, 2005.

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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02110771    
Other Study ID Numbers: 2011-A00793-38
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: September 2015
Keywords provided by Hôpital le Vinatier:
schizophrenia
social cognition
facial affects recognition
cognitive remediation
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders