Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

Detailed description: 
      Purpose:

      Rationale:

      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 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:

        1. Arm 1,Experimental: Gaïa (20h with therapist, computer assisted method)

             -  10 week-treatment, with 2 sessions of 1 hour per week, and 1 homework exercise
                without therapist per week.Individual therapy.

             -  Gaïa exercises were designed by B. Gaudelus and tutoractiv' company, for specific
                use in schizophrenia. It includes computer based and paper & pen, photos and role
                games exercises targeting the recognition of facial emotions.

             -  Computer based exercises have 5 increasing difficulty levels.

             -  Each participant practices all the modules of Gaïa.

        2. Arm 2, control: RECOS (20h with therapist, computer assisted method)

             -  10 week-treatment, with 2 sessions of 1 hour per week and 1 homework exercise
                without therapist per week.Individual therapy.

             -  RECOS (Cognitive Remediation for Schizophrenia) exercises were designed by
                Scientific Brain Training (SBT) company and P. Vianin in year 2007 for specific use
                in schizophrenia.

             -  It includes computer based and paper & pen exercises.

             -  Only the RECOS attentional function module is used in the study (5 modules
                available in the program) with gradual difficulty in 10 levels

      Condition: Schizophrenia Intervention: Behavioural: computer assisted cognitive remediation

      Study type: interventional

      Study design:

        -  Allocation: randomized

        -  Endpoint classification: efficacy study

        -  Intervention model: parallel assignment

        -  Masking: Single Blind (outcomes assessor)

        -  Primary purpose: treatment

      Official title:

      Efficacy study of GAÏA program; cognitive remediation of facial affects process in
      schizophrenia

      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 and psychosocial measures, including symptoms,
           Delusional ideas, self esteem, insight and functional outcome after 10 weeks and 20
           session of treatment and at 6 months follow-up.

        -  Change from baseline in social cognition measures, including Theory of Mind,attribution
           style, emotional conciousness and empathy processes after 10 weeks and 20 session of
           treatment and at 6 months follow-up

        -  Change from baseline in neurocognitive functioning measures, including attentional,
           working memory, processing speed, perceptive and executive functions processes 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.

           1. Scales for clinical and psychosocial functioning measurement:

        -  Positive and negative symptoms scale (PANSS)

        -  Peters and al. Delusions Inventory 21 items (PDI21)

        -  Birchwood insight scale

        -  Self-Esteem Rating Scale (SERS)

        -  Social Autonomy Scale (EAS)

           2. Tasks for social cognitive measurement

        -  Hinting task - Theory of mind

        -  Intentional Reading in Situation - Theory of mind - (LIS-V)

        -  Eyes Test - Theory of mind

        -  Ambiguous Intentions Hostility Questionary - Attribution style - (AIHQ)

        -  Levels of Emotional Awareness Scale (LEAS)

        -  Questionnaire of Cognitive and Affective Empathy (QCAE)

           3. Tasks for neurocognitive functioning measurement

        -  Attentional functions: D2 test ; Attentional Testbattery (TAP)

        -  Executive functions: Trail making test (TMT); Search keys score - Behavioural Assessment
           of Dysexecutive functions (BADS); Rey figure

        -  Working memory: memory span ; Corsi blocs ; Brief Visual Memory Test- Revised (BVMT-R)
           processing speed: Wechsler Adult Intelligence Scale IV - Code and Symbol score (WAIS IV)
           perceptive functions: HOOPER Visual Organization Test (VOT)

      Eligibility

        -  Ages Eligible for Study: 18 years to 45 years

        -  Genders Eligible for Study: Both

        -  Accepts Healthy volunteers: No
    

Intervention name(s): GAÏA - facial affect recognition targeted; RECOS - attentional process targeted
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; social cognition; facial affects recognition; cognitive remediation