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

Sponsor

Hôpital le Vinatier (Other)

Overall Status

Completed

CT.gov ID

NCT02110771

Collaborator

Hospital Center Alpes-Isère (Other), Centre Hospitalier St Anne (Other), Centre Hospitalier Intercommunal Clermont de l'Oise (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: GAÏA - facial affect recognition targeted Behavioral: RECOS - attentional process targeted	N/A

Detailed Description

Purpose:

Rationale:

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:

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.

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.

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)

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)

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 Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Facial Emotions Recognition Task(TREF) [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.

Secondary Outcome Measures

TREF (Facial emotions recognition task) [6 month follow up]
Change from baseline in symptoms measure 1 [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 [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 [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 [week 11 and 6 month follow-up]
PDI 21- Peters and al. Delusions Inventory 21 items Global score
Change from baseline in insight measure [week 11 and 6 month follow-up]
Birchwood insight scale. Global score
Change from baseline in self estime measure [week 11 and 6 month follow up]
SERS -Self-Esteem Rating Scale. Global score
Change from baseline in social functioning measure [week 11 and 6 month follow-up]
EAS -Social Autonomy Scale. Global score and relationship with others score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	centre de réhabilitation - Hôpital le Vinatier	Lyon	Rhône	France	69006

Sponsors and Collaborators

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

Investigators

Principal Investigator: Franck Nicolas, PUPH, Hôpital le Vinatier

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hôpital le Vinatier

ClinicalTrials.gov Identifier:

NCT02110771

Other Study ID Numbers:

2011-A00793-38

First Posted:

Apr 10, 2014

Last Update Posted:

Mar 3, 2016

Last Verified:

Sep 1, 2015

Keywords provided by Hôpital le Vinatier

schizophrenia

social cognition

facial affects recognition

cognitive remediation

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Mar 3, 2016