NCT01078129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

2.2 years

First QC Date

February 22, 2010

Last Update Submit

February 24, 2014

Conditions

Schizophrenia

Keywords

cognitive deficits

Outcome Measures

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).

    before and after CRT (3 months later)

Secondary Outcomes (2)

  • brain functioning (fMRI)

    before and after CRT (3 months later)

  • schizophrenia symptoms

    before CRT and 3 months later

Study Arms (2)

behavior therapy - CRT

ACTIVE COMPARATOR

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

non-CRT

SHAM COMPARATOR

no intervention

Behavioral: non-CRT

Interventions

cognitive remediation therapyBEHAVIORAL

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
behavior therapy - CRT
non-CRTBEHAVIORAL

waiting list

Also known as: no intervention
non-CRT

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital le vinatier

Bron, 69677, France

Location

Related Publications (1)

  • 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.

    PMID: 21543191DERIVED

MeSH Terms

Conditions

SchizophreniaCognition Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Thierry d'amato, MD, PhD

    Hopital le Vinatier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

March 2, 2010

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

December 1, 2010

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

FR(1)