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
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.
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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- TREF (Facial emotions recognition task) [ Time Frame: 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
- 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
- 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.
- 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
- Change from baseline in insight measure [ Time Frame: week 11 and 6 month follow-up ]Birchwood insight scale. Global score
- Change from baseline in self estime measure [ Time Frame: week 11 and 6 month follow up ]SERS -Self-Esteem Rating Scale. Global score
- 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
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
|centre de réhabilitation - Hôpital le Vinatier|
|Lyon, Rhône, France, 69006|
|Principal Investigator:||Franck Nicolas, PUPH||Hôpital le Vinatier|