Clinical trial NCT02110771: Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia
Official title: Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
social cognition
facial affects recognition
cognitive remediation
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
Collaborators: name: Hospital Center Alpes-Isère
name: Centre Hospitalier St Anne
name: Centre Hospitalier Intercommunal Clermont de l'Oise
First posted: 2014-04-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Facial Emotions Recognition Task(TREF)
timeFrame: week 11
Secondary outcomes:
measure: TREF (Facial emotions recognition task)
timeFrame: 6 month follow up
measure: Change from baseline in symptoms measure 1
timeFrame: week 11 and 6 month follow-up
measure: Change from baseline in social cognition measures
timeFrame: week 11 and 6 month follow-up
measure: Change from baseline in neurocognitive functioning measures
timeFrame: week 11and 6 month follow-up
measure: Change from baseline in symptoms measure 2
timeFrame: week 11 and 6 month follow-up
measure: Change from baseline in insight measure
timeFrame: week 11 and 6 month follow-up
measure: Change from baseline in self estime measure
timeFrame: week 11 and 6 month follow up
measure: Change from baseline in social functioning measure
timeFrame: week 11 and 6 month follow-up
Other outcomes:
Locations:
city: Lyon
country: France
facility: centre de réhabilitation - Hôpital le Vinatier
state: Rhône
Study officials:
affiliation: Hôpital le Vinatier
name: Franck Nicolas, PUPH
role: PRINCIPAL_INVESTIGATOR
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