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Clinical Trials/NCT01279070
NCT01279070
Completed
Phase 4

Efficacy of Repyflec Cognitive Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia.

Fundació Sant Joan de Déu1 site in 1 country62 target enrollmentSeptember 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Indication for Modification of Patient Cognitive Status
Sponsor
Fundació Sant Joan de Déu
Enrollment
62
Locations
1
Primary Endpoint
Executive Function
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study was to develop an integrative intervention for schizophrenia taking into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of our cognitive remediation group training: Problem Solving and Cognitive Flexibility training (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We hypothesized that training executive function and metacognition would allow us to achieve improvements in neurocognition, functioning and psychiatric symptoms of patients with schizophrenia.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
March 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aida Farreny

Dr. Aida Farreny

Fundació Sant Joan de Déu

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of schizophrenia or schizoaffective disorder
  • More than 2 years illness duration
  • Mini Mental Status Examination score over 24
  • Global Assessment of Functioning scores between 40 and 70

Exclusion Criteria

  • Current acute illness exacerbation
  • Mental Retardation
  • Neurological disorder which impairs cognition
  • Currently participating in social skills training or cognitive remediation
  • Change of antipsychotic medication one month before the trial or during the 40 study weeks
  • Diagnosis of alcohol or drug dependence within 6 months of trial commencement.

Outcomes

Primary Outcomes

Executive Function

Time Frame: Change from baseline in executive functioning at 40 weeks

Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Wilson et al., 1996). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgement, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min. 12-max. 129). A higher score indicates better performance.

Secondary Outcomes

  • Psychosocial Functioning(Change from baseline in social functioning scales at 40 weeks)
  • Psychiatric Symptoms(Change from baseline in psychiatric symptoms scales at 40 weeks)

Study Sites (1)

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