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Cognitive Remediation Therapy and Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive remediation therapy
non-CRT
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring cognitive deficits

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital le vinatier

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

behavior therapy - CRT

non-CRT

Arm Description

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

no intervention

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
schizophrenia symptoms
standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)

Full Information

First Posted
February 22, 2010
Last Updated
February 24, 2014
Sponsor
Hôpital le Vinatier
Collaborators
University Hospital, Grenoble, University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01078129
Brief Title
Cognitive Remediation Therapy and Schizophrenia
Official Title
Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
Collaborators
University Hospital, Grenoble, University Hospital, Clermont-Ferrand

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
cognitive deficits

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
behavior therapy - CRT
Arm Type
Active Comparator
Arm Description
behavior program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions) by means REHACOM® software
Arm Title
non-CRT
Arm Type
Sham Comparator
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
cognitive remediation therapy
Other Intervention Name(s)
CRT, behavioral intervention
Intervention Description
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
Intervention Name(s)
non-CRT
Other Intervention Name(s)
no intervention
Intervention Description
waiting list
Primary Outcome Measure Information:
Title
cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)
Description
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 Outcome Measure Information:
Title
brain functioning (fMRI)
Description
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)
Title
schizophrenia symptoms
Description
standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)
Time Frame
before CRT and 3 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry d'amato, MD, PhD
Organizational Affiliation
Hopital le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital le vinatier
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21543191
Citation
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.
Results Reference
derived

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Cognitive Remediation Therapy and Schizophrenia

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