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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110771
• Other study ID #: 2011-A00793-38
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: March 2, 2016
• Start date: May 2012
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	centre de réhabilitation - Hôpital le Vinatier	Lyon	Rhône

Sponsors (4)

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

Country where clinical trial is conducted

France, 

References & Publications (15)

Baron-Cohen S, Wheelwright S, Hill J, Raste Y, Plumb I. The "Reading the Mind in the Eyes" Test revised version: a study with normal adults, and adults with Asperger syndrome or high-functioning autism. J Child Psychol Psychiatry. 2001 Feb;42(2):241-51. — View Citation

Bazin N, Brunet-Gouet E, Bourdet C, Kayser N, Falissard B, Hardy-Baylé MC, Passerieux C. Quantitative assessment of attribution of intentions to others in schizophrenia using an ecological video-based task: a comparison with manic and depressed patients. Psychiatry Res. 2009 May 15;167(1-2):28-35. doi: 10.1016/j.psychres.2007.12.010. Epub 2009 Apr 5. — View Citation

Birchwood M, Smith J, Drury V, Healy J, Macmillan F, Slade M. A self-report Insight Scale for psychosis: reliability, validity and sensitivity to change. Acta Psychiatr Scand. 1994 Jan;89(1):62-7. — View Citation

Bydlowski S, Corcos M, Paterniti S, Guilbaud O, Jeammet P, Consoli SM. [French validation study of the levels of emotional awareness scale]. Encephale. 2002 Jul-Aug;28(4):310-20. French. — View Citation

Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. — View Citation

Corcoran R, Frith CD. Thematic reasoning and theory of mind. Accounting for social inference difficulties in schizophrenia. Evolutionary Psychology 3, 2005.

Franck N, Duboc C, Sundby C, Amado I, Wykes T, Demily C, Launay C, Le Roy V, Bloch P, Willard D, Todd A, Petitjean F, Foullu S, Briant P, Grillon ML, Deppen P, Verdoux H, Bralet MC, Januel D, Riche B, Roy P; Members of Cognitive Remediation Network, Vianin P. Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophr Res. 2013 Jun;147(1):68-74. doi: 10.1016/j.schres.2013.03.009. Epub 2013 Apr 9. — View Citation

Gaudelus B, Franck N. Troubles du traitement des informations faciales. Le programme GAÏA. In Franck N, editor.La remédiation cognitive. Paris: Eselvier Masson: 169-81,2012.

Gaudelus B, Virgile J, Peyroux E, Leleu A, Baudouin JY, Franck N. [Measuring impairment of facial affects recognition in schizophrenia. Preliminary study of the facial emotions recognition task (TREF)]. Encephale. 2015 Jun;41(3):251-9. doi: 10.1016/j.encep.2014.08.013. Epub 2014 Sep 17. French. — View Citation

Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. — View Citation

Lecomte T, Corbière M, Laisné F. Investigating self-esteem in individuals with schizophrenia: relevance of the Self-Esteem Rating Scale-Short Form. Psychiatry Res. 2006 Jun 30;143(1):99-108. Epub 2006 May 24. — View Citation

Leguay D, Cochet A, Matignon G, Hairy A, Fortassin O, Marion JM. [Social Autonomy Scale. First validation data]. Encephale. 1998 Mar-Apr;24(2):108-19. French. — View Citation

Peters E, Joseph S, Day S, Garety P. Measuring delusional ideation: the 21-item Peters et al. Delusions Inventory (PDI). Schizophr Bull. 2004;30(4):1005-22. — View Citation

Reniers RL, Corcoran R, Drake R, Shryane NM, Völlm BA. The QCAE: a Questionnaire of Cognitive and Affective Empathy. J Pers Assess. 2011 Jan;93(1):84-95. doi: 10.1080/00223891.2010.528484. — View Citation

Vianin P.Cognitive Remediation for schizophrenia. Presentation of the RECOS program.Anales Medico psychologiques 165: 200-205, 2007

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial Emotions Recognition Task(TREF)	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.	week 11	No
Secondary	TREF (Facial emotions recognition task)		6 month follow up	No
Secondary	Change from baseline in symptoms measure 1	PANSS - Positive and negative symptoms scale. global score, positive sub scale score and negative sub scale score	week 11 and 6 month follow-up	Yes
Secondary	Change from baseline in social cognition measures	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	week 11 and 6 month follow-up	Yes
Secondary	Change from baseline in neurocognitive functioning measures	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.	week 11and 6 month follow-up	Yes
Secondary	Change from baseline in symptoms measure 2	PDI 21- Peters and al. Delusions Inventory 21 items Global score	week 11 and 6 month follow-up	Yes
Secondary	Change from baseline in insight measure	Birchwood insight scale. Global score	week 11 and 6 month follow-up	Yes
Secondary	Change from baseline in self estime measure	SERS -Self-Esteem Rating Scale. Global score	week 11 and 6 month follow up	Yes
Secondary	Change from baseline in social functioning measure	EAS -Social Autonomy Scale. Global score and relationship with others score	week 11 and 6 month follow-up	Yes