Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study

Schizophrenia Clinical Trial

Official title:

Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201888
• Other study ID #: PR-2009-15
• Secondary ID: PI09/90483
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: July 25, 2014
• Start date: January 2010
• Est. completion date: February 2014

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Computer-assisted cognitive training
Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.

Other:
• Computerized active condition
Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
• Treatment as usual (TAU)
TAU: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities.

Locations

Country	Name	City	State
Spain	FIDMAG Germanes Hospitalàries Research Foundation	Barcelona

Sponsors (4)

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

Country where clinical trial is conducted

Spain, 

Outcome

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