Schizophrenia Clinical Trial
Official title:
Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study
Verified date | July 2014 |
Source | FIDMAG Germanes Hospitalàries |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence suggests has consequences for functional adaptation and which cause difficulties in social re-integration after hospitalization. The investigators propose a large scale, multicentric study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed at answering outstanding questions concerning the effectiveness of cognitive estimulation therapy for schizophrenic cognitive impairment. Specifically, the study will examine a) issues related to the size of the effect compared to treatment as usual and compared to a control intervention; b) generalizability of improvement to cognitive function and social cognition in daily life; and c) the durability of therapeutic gains after the end of treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three treatment conditions: a computer- assisted cognitive estimulation program (n=64), non-structured time on computer (n=64) and treatment as usual (n=64). A battery of neurocognitive tests of memory and executive function, including 'ecologically valid' measures, will be administered by blind evaluators at baseline, after 6 months of cognitive estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will be also be assessed at baseline, after the treatment and at follow-up.
Status | Completed |
Enrollment | 130 |
Est. completion date | February 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - schizophrenia or schizoaffective disorder fulfilling the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosis - estimated premorbid intelligence quotient (IQ) in the normal range - chronic illness (i.e. duration =two years) - relative clinical stability (i.e. the patients had not experienced any recent exacerbation of symptoms). Exclusion Criteria: - history of brain trauma - alcohol or substance abuse/dependence within the previous six months. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | FIDMAG Germanes Hospitalàries Research Foundation | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Salvador Sarró, MD | Centro de Investigación Biomédica en Red de Salud Mental, Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain, Instituto de Salud Carlos III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Memory test battery | memory test battery Rivermead Behavioural Memory Test (RBMT)(Wilson, 1985) a memory test battery and the executive test battery, the Behavioural Assessment of the Dysexecutive Syndrome (BADS)(Wilson, 1996) | Six months | No |
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