Clinical trial NCT02201888: Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study
Official title: Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Rehabilitation
Cognition
Lead sponsor: FIDMAG Germanes Hospitalàries
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Centro de Investigación Biomédica en Red de Salud Mental
name: Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain
First posted: 2014-07-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Memory test battery
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: FIDMAG Germanes Hospitalàries Research Foundation
Study officials:
affiliation: FIDMAG Germanes Hospitalàries Research Foundation
name: Peter J McKenna, MD
role: STUDY_DIRECTOR
affiliation: FIDMAG Germanes Hospitalàries Research Foundation
name: Jesus J Gomar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: FIDMAG Germanes Hospitalàries Research Foundation
name: Edith Pomarol-Clotet, MD, PhD
role: STUDY_CHAIR
References: