Clinical trial NCT01598220: Computer Assisted Cognitive Remediation Program in Schizophrenia
Official title: Efficacy Study of a Computer Cognitive Remediation Program in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
cognitive remediation therapy
cognition
quality of life
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether computer-assisted cognitive remediation therapy is effective in the treatment of cognitive deficits in schizophrenia.

Detailed description: Schizophrenia can be considered a chronic illness that affects all aspects of daily life. Cognitive deficits seems to play a key role that interferes directly in the functional adaptation.

Cognitive remediation therapy (CRT) emerges as a psychological intervention that target cognitive impairment. But, the use of computerized or papel an pencil procedures for remediation cognitive deficits remains controversial. Nonetheless, computer tasks offer a number of advantages compared to those of paper and pencil. The most noteworthy advantages are to enhance patient's motivation just because the sensory variety that the exercises presented or the possibility to provide immediate feedback. Furthermore, the possibility to present custom-tailored and adapted tasks taking into accounts the patients deficits and their evolution in the process of the psychological therapy is another important feature of computer-assisted cognitive remediation therapy.

Eligibility criteria: Inclusion Criteria:

* DSM-IV (APA, 1994)criteria for schizophrenia disorder
* Estimated IQ of 85 or superior by Vocabulary subtest, Wechsler Adult Intelligence Scale-III (WAIS-III)
* Patients were considered sufficiently stable if they had a Global Assessment of Functioning Scale (GAF)score of 40 or superior and they maintained a stable dose and type of psychiatric medication for at least 1 moth prior to inclusion.

Exclusion Criteria:

* Non presence of cognitive impairment confirmed by neurocognitive assessment
* Traumatic brain injury or history of neurologic illness.
* Electroconvulsive therapy in the last year.
* Psychiatric comorbidity.
* Plan to change medication during the trial.

Primary outcomes:
measure: Change in neurocognitive outcomes
timeFrame: Change from Baseline in neurocognitive measures up to the end of intervention at 6 months
Secondary outcomes:
measure: Change in functional outcomes
timeFrame: Change from Baseline in functional measures up to the end of intervention at 6 months
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Gemma Garrido Garcia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wykes T, Reeder C, Landau S, Everitt B, Knapp M, Patel A, Romeo R. Cognitive remediation therapy in schizophrenia: randomised controlled trial. Br J Psychiatry. 2007 May;190:421-7. doi: 10.1192/bjp.bp.106.026575.
citation: Grynszpan O, Perbal S, Pelissolo A, Fossati P, Jouvent R, Dubal S, Perez-Diaz F. Efficacy and specificity of computer-assisted cognitive remediation in schizophrenia: a meta-analytical study. Psychol Med. 2011 Jan;41(1):163-73. doi: 10.1017/S0033291710000607. Epub 2010 Apr 12.