SchizophreniaNCT02110771
Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia
A study testing GAÏA - facial affect recognition targeted and RECOS - attentional process targeted in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- GAÏA - facial affect recognition targeted and RECOS - attentional process targeted
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the detailed 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:
- 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
- Conditions
- Schizophrenia
- Being tested
- GAÏA - facial affect recognition targeted, RECOS - attentional process targeted
- Keywords
- schizophrenia, social cognition, facial affects recognition, cognitive remediation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAÏA - facial affect recognition targetedBehavioural
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 targetedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GAÏA - facial affect recognition targeted | Experimental | 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. Receives: Behavioral: GAÏA - facial affect recognition targeted |
| RECOS - attentional process targeted | Active comparator | 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 Receives: Behavioral: RECOS - attentional process targeted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 11
Secondary outcomes (8)
TREF (Facial emotions recognition task)
Measured: 6 month follow up
Change from baseline in symptoms measure 1
PANSS - Positive and negative symptoms scale. global score, positive sub scale score and negative sub scale score
Measured: week 11 and 6 month follow-up
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
Measured: week 11 and 6 month follow-up
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.
Measured: week 11and 6 month follow-up
Change from baseline in symptoms measure 2
PDI 21- Peters and al. Delusions Inventory 21 items Global score
Measured: week 11 and 6 month follow-up
Change from baseline in insight measure
Birchwood insight scale. Global score
Measured: week 11 and 6 month follow-up
Change from baseline in self estime measure
SERS -Self-Esteem Rating Scale. Global score
Measured: week 11 and 6 month follow up
Change from baseline in social functioning measure
EAS -Social Autonomy Scale. Global score and relationship with others score
Measured: week 11 and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMay 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Center Alpes-Isère, Centre Hospitalier St Anne, Centre Hospitalier Intercommunal Clermont de l'Oise
- Responsible party
- Sponsor
- Investigators
- Franck Nicolas, PUPH, Principal investigator, Hôpital le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110771
- Sponsor's protocol ID
- 2011-A00793-38
- Status last verified
- Sep 2015
- First submitted
- 24 Feb 2014
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vianin P.Cognitive Remediation for schizophrenia. Presentation of the RECOS program.Anales Medico psychologiques 165: 200-205, 2007
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; Other members of the 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.
PubMed 23583327Gaudelus 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.
Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
PubMed 3616518Peters 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. doi: 10.1093/oxfordjournals.schbul.a007116.
PubMed 15954204Birchwood 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. doi: 10.1111/j.1600-0447.1994.tb01487.x.
PubMed 7908156Lecomte T, Corbiere M, Laisne 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. doi: 10.1016/j.psychres.2005.08.019. Epub 2006 May 24.
PubMed 16725210Leguay 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.
PubMed 9622789Corcoran R, Frith CD. Thematic reasoning and theory of mind. Accounting for social inference difficulties in schizophrenia. Evolutionary Psychology 3, 2005.
Bazin N, Brunet-Gouet E, Bourdet C, Kayser N, Falissard B, Hardy-Bayle 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.
PubMed 19346006Baron-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.
PubMed 11280420Combs 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. doi: 10.1080/13546800600787854.
PubMed 17453895Reniers RL, Corcoran R, Drake R, Shryane NM, Vollm 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.
PubMed 21184334Bydlowski 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.
PubMed 12232540Gaudelus 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.
PubMed 25240938
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia
- ClinicalTrials.gov ID
- NCT02110771
- Acronym / sponsor ID
- 2011-A00793-38
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, social cognition, facial affects recognition, cognitive remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Collaborators
- Hospital Center Alpes-Isère, Centre Hospitalier St Anne, Centre Hospitalier Intercommunal Clermont de l'Oise
- Study start
- May 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAÏA - facial affect recognition targeted | Experimental | Behavioral: GAÏA - facial affect recognition targetedGAÏA: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. |
| RECOS - attentional process targeted | Active comparator | Behavioral: RECOS - attentional process targetedRECOS (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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAÏA - facial affect recognition targeted2 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. | Behavioural | GAÏA - facial affect recognition targeted |
| RECOS - attentional process targeted2 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. | Behavioural | RECOS - attentional process targeted |
Primary outcome
Facial Emotions Recognition Task(TREF)
Time frame: 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.
8 secondary outcomes
TREF (Facial emotions recognition task)
Time frame: 6 month follow up
Change from baseline in symptoms measure 1
Time frame: week 11 and 6 month follow-up
Change from baseline in social cognition measures
Time frame: week 11 and 6 month follow-up
Change from baseline in neurocognitive functioning measures
Time frame: week 11and 6 month follow-up
Change from baseline in symptoms measure 2
Time frame: week 11 and 6 month follow-up
Change from baseline in insight measure
Time frame: week 11 and 6 month follow-up
Change from baseline in self estime measure
Time frame: week 11 and 6 month follow up
Change from baseline in social functioning measure
Time frame: week 11 and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- BackgroundVianin P.Cognitive Remediation for schizophrenia. Presentation of the RECOS program.Anales Medico psychologiques 165: 200-205, 2007
- Background: PubMed 23583327Franck 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; Other members of the 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.
- BackgroundGaudelus 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.
- Background: PubMed 3616518Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
- Background: PubMed 15954204Peters 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. doi: 10.1093/oxfordjournals.schbul.a007116.
- Background: PubMed 7908156Birchwood 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. doi: 10.1111/j.1600-0447.1994.tb01487.x.
- Background: PubMed 16725210Lecomte T, Corbiere M, Laisne 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. doi: 10.1016/j.psychres.2005.08.019. Epub 2006 May 24.
- Background: PubMed 9622789Leguay 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.
- BackgroundCorcoran R, Frith CD. Thematic reasoning and theory of mind. Accounting for social inference difficulties in schizophrenia. Evolutionary Psychology 3, 2005.
- Background: PubMed 19346006Bazin N, Brunet-Gouet E, Bourdet C, Kayser N, Falissard B, Hardy-Bayle 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.
- Background: PubMed 11280420Baron-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.
- Background: PubMed 17453895Combs 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. doi: 10.1080/13546800600787854.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck Nicolas, PUPH principal investigator
Hôpital le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAÏA - facial affect recognition targeted and RECOS - attentional process targeted in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Emotions Recognition Task(TREF) (time frame: week 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02110771, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.