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Chronic SchizophreniaRemedRehabNCT01891929

Cognitive Remediation and Sheltered Employment in Schizophrenia

A study testing RECOS (COgnitive REmediation for Schizophrenia) and TAU (Treatment As Usual) in people with Chronic Schizophrenia, run by Hôpital le Vinatier at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Chronic Schizophrenia
What is being tested?
RECOS (COgnitive REmediation for Schizophrenia) and TAU (Treatment As Usual)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
13 sitesFrance
Study dates
Jul 2013to 22 Oct 2018
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • Hôpital Le Vinatier Pôle Centre

    Bron, 69378

  • Hôpital Le Vinatier Pôle Est

    Bron, 69677

  • Mental Health Center (MGEN)

    Lille, 59000

  • Hôpital Ste Marguerite

    Marseille, 13009

  • Nantes University Hospital

    Nantes, 44093

  • Centre Hospitalier de Niort

    Niort, 79000

  • Hôpital Ste Anne

    Paris, 75014

  • Centre Hospitalier Henri Laborit

    Poitiers, 86021

  • Mental Health Center (MGEN)

    Rueil-Malmaison, 92500

  • Saint-Cyr Hospital

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

  • Centre Hospitalier de St-Egrève

    Saint-Egrève, 38120

  • Centre de Santé Mentale Angevin (CESAME)

    Sainte-Gemmes-sur-Loire, 49130

  • Tours University Hospital

    Tours, 37100

Other trials in France

About this study

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

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 :
  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. the duration of such employments in sheltered areas.
  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. Estimating the impact of cognitive remediation on integration in sheltered employment.
Being tested
RECOS (COgnitive REmediation for Schizophrenia), TAU (Treatment As Usual)
Keywords
Schizophrenia, Cognitive Remediation, Working abilities and social functioning
Medical subject headings
Schizophrenia, Social Adjustment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RECOS (COgnitive REmediation for Schizophrenia)Behavioural

    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)Behavioural

    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).

Study groups in NCT01891929
Study groupRoleWhat they receive
RECOSExperimentalThe 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.
Receives: Behavioral: RECOS (COgnitive REmediation for Schizophrenia)
TAU (Treatment as Usual)Active comparatorThe 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.
Receives: Behavioral: TAU (Treatment As Usual)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (2)

  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)

    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).

    Measured: 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).

  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).

    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).

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completion22 Oct 2018
  4. Study completion22 Oct 2018

Resources

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
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01891929
Sponsor's protocol ID
2012-A01676-37
Acronym
RemedRehab
Status last verified
Feb 2019
First submitted
28 Jun 2013
Last updated
25 Feb 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 21981893

  • 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 23583327

Questions about this trial

What is this clinical trial studying?

A study testing RECOS (COgnitive REmediation for Schizophrenia) and TAU (Treatment As Usual) in people with Chronic Schizophrenia, run by Hôpital le Vinatier at 13 sites 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 11 inclusion and 6 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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?

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)). 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 NCT01891929, which also lists 2 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 25 Feb 2019.

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