CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
GAÏA - facial affect recognition targeted +1 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02110771
NCT02110771N/ACompleted

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

Hôpital le Vinatier·interventional·Posted Apr 10, 2014·Updated Mar 3, 2016

In Brief

A clinical study evaluating GAÏA - facial affect recognition targeted and RECOS - attentional process targeted for Schizophrenia. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesFrance

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 10, 2014
Enrollment StartMay 1, 2012
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.2 years ago

Interventions

GAÏA - facial affect recognition targetedbehavioral

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.

RECOS - attentional process targetedbehavioral

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.