Cognitive Remediation Therapy and Schizophrenia

NCT ID: NCT01078129

Last Updated: 2014-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

cognitive remediation therapy

Intervention Type BEHAVIORAL

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

non-CRT

no intervention

Group Type SHAM_COMPARATOR

non-CRT

Intervention Type BEHAVIORAL

waiting list

Interventions

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cognitive remediation therapy

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

Intervention Type BEHAVIORAL

non-CRT

waiting list

Intervention Type BEHAVIORAL

Other Intervention Names

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CRT behavioral intervention no intervention

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* addiction, neurological disease
* only for second randomized patient participating in MRI study (n=30) : MRI counterindications
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role collaborator

Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry d'amato, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital le Vinatier

Locations

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Hôpital le vinatier

Bron, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 21543191 (View on PubMed)

Other Identifiers

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2005-094B

Identifier Type: -

Identifier Source: org_study_id

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