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

March 2, 2016 updated by: Hôpital le Vinatier

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhône
      • Lyon, Rhône, France, 69006
        • centre de réhabilitation - Hôpital le Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TREF (Facial emotions recognition task)
Time Frame: 6 month follow up
6 month follow up
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
week 11 and 6 month follow-up
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
week 11 and 6 month follow-up
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.
week 11and 6 month follow-up
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
week 11 and 6 month follow-up
Change from baseline in insight measure
Time Frame: week 11 and 6 month follow-up
Birchwood insight scale. Global score
week 11 and 6 month follow-up
Change from baseline in self estime measure
Time Frame: week 11 and 6 month follow up
SERS -Self-Esteem Rating Scale. Global score
week 11 and 6 month follow up
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
week 11 and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Collaborators

Hospital Center Alpes-Isère
Centre Hospitalier St Anne
Centre Hospitalier Intercommunal Clermont de l'Oise

Investigators

  • Principal Investigator: Franck Nicolas, PUPH, Hopital Le Vinatier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00793-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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