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Cognitive Remediation and Sheltered Employment in Schizophrenia (RemedRehab)

Primary Purpose

Chronic Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

RECOS (COgnitive REmediation for Schizophrenia)

TAU (Treatment As Usual)

About this trial

This is an interventional treatment trial for Chronic Schizophrenia focused on measuring Schizophrenia, Cognitive Remediation, Working abilities and social functioning

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
Stable symptomatology during the month preceding the inclusion.
Psychotropic treatment unchanged during the month preceding the inclusion (change no more than 25 % posology).
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.

Exclusion Criteria:

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RECOS

TAU (Treatment as Usual)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Compared evolution, in both arms (RECOS and TAU) of the scores obtained in the different neuropsychological tests, and in the scales of clinical symptomatology (PANSS, questionnaires of insight, self-respect, well being, social autonomy, and cognitive complaint) at the moment of the inclusion (month M0), early after the training period of Cognitive Remediation or Treatment as Usual (M3), and 6 month after (M9).

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).

Compared evolution, in both arms (RECOS and TAU) of the scores obtained in the different neuropsychological tests, and in the scales of occupational integration (EATR), clinical symptomatology (PANSS, questionnaires of insight, self-respect, well being, social autonomy, and cognitive complaint) after the training period of Remediation and at the moment of the entry in sheltered working environment (month M3), and 6 months later (month M9).

Full Information

NCT ID

NCT01891929

First Posted

June 28, 2013

Last Updated

February 22, 2019

Sponsor

Hôpital le Vinatier

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01891929

Brief Title

Cognitive Remediation and Sheltered Employment in Schizophrenia

Acronym

RemedRehab

Official Title

Specific Cognitive Remediation for Schizophrenia (RECOS) and Sheltered Employment: a Multicentre Controlled Randomized Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

July 2013 (Actual)

Primary Completion Date

October 22, 2018 (Actual)

Study Completion Date

October 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hôpital le Vinatier

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study, driven on schizophrenic patients, is aimed at : 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). 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. Realizing a comparative analysis, in both arms, of : 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) the duration of such employments in sheltered areas. 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. Estimating the impact of cognitive remediation on integration in sheltered employment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Schizophrenia

Keywords

Schizophrenia, Cognitive Remediation, Working abilities and social functioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RECOS

Arm Type

Experimental

Arm Description

Arm Title

TAU (Treatment as Usual)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

RECOS (COgnitive REmediation for Schizophrenia)

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

TAU (Treatment As Usual)

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Description

Time Frame

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).

Title

Description

Time Frame

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Stable symptomatology during the month preceding the inclusion. Psychotropic treatment unchanged during the month preceding the inclusion (change no more than 25 % posology). 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. Exclusion Criteria: 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.

Overall Study Officials: