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CompletedNCT01078129Updated Feb 25, 2014

Cognitive Remediation Therapy and Schizophrenia

An interventional study of cognitive remediation therapy and non-CRT in Schizophrenia, sponsored by Hôpital le Vinatier. Completed at 1 site in France. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-25.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study summary

Objectives:

The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with schizophrenia.

Read the detailed description

Methods:

In a 2 arms blind study versus sham,80 patients with schizophrenia were enrolled in a program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software. Measures of cognitive functioning using the Cogtest® battery as well as social autonomy (Social Autonomy Scale, EAS) and schizophrenia symptoms (Positive And Negative Syndrome Scale, PANSS) were undertaken at the beginning and the end of the meetings of remediation.

Among those 80 participants, 30 patients to (15 active / 15 sham) were randomized to participate in an fMRI study in order to investigate the impact of such CRT program on brain functioning (n-back task before CRT and 3 months later).

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Conditions studied

  • Schizophrenia

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Keywords

  • cognitive deficits
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 77 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • schizophrenia (DSM IV criteria)
  • remitted symptoms
  • french language
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • addiction, neurological disease
  • only for second randomized patient participating in MRI study (n=30) : MRI counterindications
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
77 participants (actual)

Study arms

  • Active comparator
    behavior therapy - CRT

    behavior program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions) by means REHACOM® software

    Behavioral: cognitive remediation therapy

  • Sham comparator
    non-CRT

    no intervention

    Behavioral: non-CRT

Interventions

  • Behavioralcognitive remediation therapy

    program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software

    Also known as: CRT, behavioral intervention

  • Behavioralnon-CRT

    waiting list

    Also known as: no intervention

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What researchers measure

Primary outcomes

  1. cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)

    standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).

    Time frame: before and after CRT (3 months later)

Secondary outcomes

  1. brain functioning (fMRI)

    fMRI during a n-back task, 2 times, before CRT and 3 months later. The 2 sub-groups of 15 patients will be compared with healthy subjects performances at the same task.

    Time frame: before and after CRT (3 months later)

  2. schizophrenia symptoms

    standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)

    Time frame: before CRT and 3 months later

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Study locations

1 site
  • Hôpital le vinatier
    Bron, 69677, France
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References and documents

Publications

  • Bor J, Brunelin J, d'Amato T, Costes N, Suaud-Chagny MF, Saoud M, Poulet E. How can cognitive remediation therapy modulate brain activations in schizophrenia? An fMRI study. Psychiatry Res. 2011 Jun 30;192(3):160-6. doi: 10.1016/j.pscychresns.2010.12.004. Epub 2011 May 2. PubMed 21543191 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01078129
Lead sponsor
Hôpital le Vinatier
Collaborators
University Hospital, Grenoble, University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Mar 2, 2010
Start date
Jan 2006
Primary completion
Mar 2008
Completion
Dec 2010
Last update
Feb 25, 2014

Study contacts

Thierry d'amato, MD, PhD
principal investigator · Hopital le Vinatier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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