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

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.

Conditions

• Schizophrenia

Interventions

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.

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.

Sponsors & Collaborators

• Hospital Center Alpes-Isère

  collaborator OTHER

• Centre Hospitalier St Anne

  collaborator OTHER

• Centre Hospitalier Intercommunal Clermont de l'Oise

  collaborator UNKNOWN

• Hôpital le Vinatier

  lead OTHER

Principal Investigators

• Franck Nicolas, PUPH · Hôpital le Vinatier

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-10-31

Completion

2015-10-31

Countries

• France

Study Locations