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

Hôpital le Vinatier

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: RECOS - attentional process targeted; Behavioral: GAÏA - facial affect recognition targeted

Study type: Interventional

Funder types: Other

Identifiers

NCT02110771

2011-A00793-38

Details and patient eligibility

About

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.

Full 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

Enrollment: 33 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

33 participants in 2 patient groups

GAÏA - facial affect recognition targeted

Experimental group

Description:

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.

Treatment:

Behavioral: GAÏA - facial affect recognition targeted

RECOS - attentional process targeted

Active Comparator group

Description:

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

Treatment:

Behavioral: RECOS - attentional process targeted