Cognitive Remediation and Sheltered Employment in Schizophrenia

NCT01891929 | Completed DMC

• 1 other identifier: 2012-A01676-37
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 13

Brief Summary

This study, driven on schizophrenic patients, is aimed at :

1. 1.Measuring the efficiency of the cognitive remediation program RECOS (COgnitive REmediation in Schizophrenia) on the capacity of the patients suffering from schizophrenia to improve the integration in sheltered employment (ESAT and EA).
2. 2.Comparing the efficiency of the program of cognitive remediation RECOS (RECOS arm) to the one of an usual program of coverage/care (TAU arm = Treatment As Usual) on integration in sheltered employment of patients suffering from schizophrenia.
3. 3.Realizing a comparative analysis, in both arms, of :
4. 4.the number of working hours achieved in sheltered environment during the 6 months following the two programs (reported to the working time planned by the contract of employment)
5. 5.the duration of such employments in sheltered areas.
6. 6.Estimating the impact of RECOS on the neuropsychological variables, the symptomatology, the consciousness of the disorders(insight), the quality of life and the social autonomy before the treatment (month M0), at the end of the treatment (month M3), and 6 months later (month M9), and looking for a correlation between the improvement of these parameters and sheltered employment.
7. 7.Estimating the impact of cognitive remediation on integration in sheltered employment.

Conditions

Chronic Schizophrenia

Keywords

Schizophrenia; Cognitive Remediation; Working abilities and social functioning

Outcome Measures

Primary Outcomes (1)

• Number of worked hours during the first 6 months of the contract of employment

  Compared evolution in both arms (RECOS and TAU) of the number of worked hours, with regard to the number of hours planned in the contract of employment, during the 6 months following the entry in sheltered working environment (i.e. an external, validated and strong measure of the capacity of the patient to fit professionally).

  Outcome measures are daily assessed during 6 months (M4 to M9)

Secondary Outcomes (2)

• Compared evolution of the neuropsychological and clinical balance sheets between the beginning and the end of the Cognitive Remediation period (or the end of the "Treatment As Usual" period for the TAU arm)

  Scores are assessed 3 times: at M0 (Inclusion), at M3 (after Cognitive Remediation or Treatment As Usual), and at M9 (6 month after end of treatment).

• Compared evolution of the neuropsychological and clinical balance sheets during the 6 first months of working contract (i.e. following the end of the training Cognitive Remediation period or after the "Treatment As Usual" period for the TAU arm).

  Neuropsychological and clinical scores are assessed twice : at M3 (after Cognitive Remediation or Treatment As Usual), and at M9 (after 6 months of working period). Occupational integration (EATR) is assessed twice at the same moments (M3 & M9).

Study Arms (2)

RECOS

EXPERIMENTAL

The RECOS program (COgnitive REmediation for Schizophrenia) was designed by SBT Company and adapted by Vianin et al (2007) for specific use in schizophrenia. It includes computer based and paper and pencil exercises that target 6 main cognitive functions (selective attention; verbal memory; visuo-spatiale attention and memory, working memory, reasoning, and speed of execution) which have been recommended by the MATRICS consensus. Each exercise has 10 difficulty levels. Allocation of the training modules in RECOS is determined according to the standard scores obtained in the comprehensive neuropsychological assessment. Each patient participates in the module corresponding to his/her most altered cognitive area.

Behavioral: RECOS (COgnitive REmediation for Schizophrenia)

TAU (Treatment as Usual)

ACTIVE COMPARATOR

The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by every service of the various inquiring centers involved. No additional session will be proposed.

Behavioral: TAU (Treatment As Usual)

Interventions

RECOS (COgnitive REmediation for Schizophrenia) BEHAVIORAL

Every RECOS patient will benefit, with his therapist, from 2 sessions of 1 hour of training per week over a 14 weeks period (M1 to M3), plus 1 hour per week of task to be realized at home. All in all, it is thus about a training period of 42 hours. After remediation, the follow-up of the patient will be led by his therapist with monthly appointments during 6 months (M4 to M9). In parallel, neuropsychological and clinical scores will be assessed before (M0) and after the training period (M3), as well as at the end of the study (M9). Working and relational abilities will be assessed at the beginning and at the end of the working period (M4 and M9).

RECOS

TAU (Treatment As Usual) BEHAVIORAL

The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by every service of the various inquiring centers involved. No additional session will be proposed. In parallel, neuropsychological and clinical scores will be assessed before (M0) and after the training period (M3), as well as at the end of the study (M9). Working and relational abilities will be assessed at the beginning and at the end of the working period (M4 and M9).

TAU (Treatment as Usual)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 18 to 50 years.
• Schizophrenia according to the criteria of the DSM-IV-TR.
• Project of entry to ESAT or to EA in the 6 weeks which follow.
• IQ \> 70 (F-NART).
• Overdrawn performances in at least one of the 6 functions estimated by the kit of neuropsychological tests.
• French mother tongue.
• Informed and signed consent by the patient.
• Agreement of the guardian (for protected adults).
• Membership in a national insurance scheme.

You may not qualify if:

• Dependence and recent abuses of cannabis (\> 2 / week) or in any other substance (according to the criteria of the DSM-IV-TR), except tobacco.
• Neurological disorders of vascular, infectious or neurodegenerative origin; dyschromatopsie.
• Taking of medicine with somatic tropism having a cerebral or psychic impact (eg: corticoids).
• Simultaneous participation to any other program of remediation targeting the neurocognitive deficits.
• Resistance to neuroleptic.
• Reading and writing not acquired.

Sponsors & Collaborators

• Hôpital le Vinatier: lead
• Sainte Anne Hospital (Paris): collaborator
• Clermont-de-l'Oise Hospital (Clermont-de-l'Oise): collaborator
• Saint-Egrève Hospital (Saint-Egrève): collaborator
• Centre Hospitalier de Niort: collaborator
• Sainte-Marguerite Hospital (Marseille): collaborator
• Centre Hospitalier Henri Laborit: collaborator
• University Hospital, Tours: collaborator
• Mental Health Center MGEN (Rueil-Malmaison): collaborator
• Nantes University Hospital: collaborator
• Mental Health Center MGEN (Lille): collaborator

Study Sites (13)

Hôpital Le Vinatier Pôle Centre

Bron, 69378, France

Location

Hôpital Le Vinatier Pôle Est

Bron, 69677, France

Location

Mental Health Center (MGEN)

Lille, 59000, France

Location

Hôpital Ste Marguerite

Marseille, 13009, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Centre Hospitalier de Niort

Niort, 79000, France

Location

Hôpital Ste Anne

Paris, 75014, France

Location

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

Location

Mental Health Center (MGEN)

Rueil-Malmaison, 92500, France

Location

Saint-Cyr Hospital

Saint-Cyr-au-Mont-d'Or, 69450, France

Location

Centre Hospitalier de St-Egrève

Saint-Egrève, 38120, France

Location

Centre de Santé Mentale Angevin (CESAME)

Sainte-Gemmes-sur-Loire, 49130, France

Location

Tours University Hospital

Tours, 37100, France

Location

Related Publications (2)

• Deppen P, Sarrasin Bruchez P, Dukes R, Pellanda V, Vianin P. [Cognitive remediation program for individuals living with schizophrenia (Recos): preliminary results]. Encephale. 2011 Sep;37(4):314-21. doi: 10.1016/j.encep.2011.02.002. Epub 2011 Apr 9. French.

  PMID: 21981893 BACKGROUND

• 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.

  PMID: 23583327 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Social Adjustment

Interventions

Cognitive Remediation; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nicolas FRANCK, Professor

  University Service of Rehabilitation (SUR) of the Vinatier Hospital

  PRINCIPAL INVESTIGATOR

• Brice MARTIN, Doctor

  University Service of Rehabilitation (SUR) of the Vinatier Hospital

  STUDY DIRECTOR

• Isabelle AMADO, Doctor

  Center of Study and Clinical Research (CERC) of the Ste Anne Hospital

  STUDY DIRECTOR

• Corinne LAUNAY, Doctor

  Center of Study and Clinical Research (CERC) of the Ste Anne Hospital

  STUDY DIRECTOR

• Marie-Cécile BRALET, Doctor

  Service CRISALID of the Clermont-de-l'Oise's Hospital

  STUDY DIRECTOR

• Elisabeth GIRAUD-BARO, Doctor

  Saint-Egrève's Hospital

  STUDY DIRECTOR

• Julien DUBREUCQ, Doctor

  Saint-Egrève's Hospital

  STUDY DIRECTOR

• Pascal BLOCH, Doctor

  Niort's Hopsital

  STUDY DIRECTOR

• Christophe LANCON, Professor

  Sainte Marguerite Hospital

  STUDY DIRECTOR

• Eric FAKRA, Doctor

  Sainte Marguerite Hospital

  STUDY DIRECTOR

• Jean-Michel ZAKOIAN, Professor

  Ecole Nationale de la statistique

  STUDY CHAIR

• Christian FRANCQ, Professor

  Ecole Nationale de la statistique

  STUDY CHAIR

• Pascal VIANIN, Doctor

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

• Nathalie GUILLARD-BOUHET, Doctor

  Henri Laborit Hospital

  STUDY DIRECTOR

• Muriel BONAÏTI, Doctor

  Saint Cyr Hospital

  STUDY DIRECTOR

• Jérome GRAUX, Doctor

  Tours University Hospital

  STUDY DIRECTOR

• Bernard DUBOUIS, Doctor

  Mental Health Center MGEN (Rueil-Malmaison)

  STUDY DIRECTOR

• Vincent SCHAER, Doctor

  Mental Health Center MGEN (Rueil-Malmaison)

  STUDY DIRECTOR

• Jérome SETTON, Doctor

  Mental Health Center MGEN (Rueil-Malmaison)

  STUDY DIRECTOR

• Vincent DELAUNAY, Doctor

  Nantes University Hospital

  STUDY DIRECTOR

• Marion CHIRIO-ESPITALIER, Doctor

  Nantes University Hospital

  STUDY DIRECTOR

• Ingrid DUR, Doctor

  Mental Health Center MGEN (Lille)

  STUDY DIRECTOR

• Sophie DELILLE, Doctor

  Mental Health Center MGEN (Lille)

  STUDY DIRECTOR

• Olivier MAZAS, Doctor

  Mental Health Center MGEN (Lille)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University professor - Hospital practitioner

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: July 1, 2013
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)