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Cognitive Remediation Therapy and Schizophrenia

Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01078129
Enrollment
77
Registered
2010-03-02
Start date
2006-01-31
Completion date
2010-12-31
Last updated
2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

cognitive deficits

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).

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

BEHAVIORALnon-CRT

waiting list

Sponsors

University Hospital, Grenoble
CollaboratorOTHER
University Hospital, Clermont-Ferrand
CollaboratorOTHER
Hôpital le Vinatier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)before and after CRT (3 months later)standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).

Secondary

MeasureTime frameDescription
brain functioning (fMRI)before and after CRT (3 months later)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 symptomsbefore CRT and 3 months laterstandardised psychometric scale measuring Positive an Negative Symptoms (PANSS)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026