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Completed

NCT Number: NCT01891929

Cognitive Remediation and Sheltered Employment in Schizophrenia

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

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. 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. Realizing a comparative analysis, in both arms, of :

1. 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) 2. the duration of such employments in sheltered areas. 4. 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. 5. Estimating the impact of cognitive remediation on integration in sheltered employment.

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Key information

Conditions

Chronic Schizophrenia Behavior Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Social Adjustment Social Behavior

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Le Vinatier Pôle Centre, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

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

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

    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 outcomes

  1. 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)

    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).

    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).

  2. 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).

    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).

    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).

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RemedRehab

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 3, 2013
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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