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Efficacy of Repyflec Cognitive Training for Patients With Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Fundació Sant Joan de Déu.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT01279070
First received: January 14, 2011
Last updated: January 18, 2011
Last verified: November 2009
History of Changes

January 14, 2011
January 18, 2011
September 2006
January 2008   (final data collection date for primary outcome measure)
Baseline [ Time Frame: At 0 weeks ] [ Designated as safety issue: No ]
Screening and Assessment: To assess cognitive functioning, social functioning, symptomatology and Theory of Mind.
Same as current
Complete list of historical versions of study NCT01279070 on ClinicalTrials.gov Archive Site
  • Half-treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    To assess social functioning, symptomatology and Theory of Mind.

    Neuropsychological evaluation was not carried out the second month of training to avoid the effects of learning.

  • Post-treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    To assess cognitive functioning,social functioning, symptomatology and Theory of Mind.
  • Follow-up [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    To assess cognitive functioning, social functioning, symptomatology and Theory of Mind, 6 month after finishing treatment.
Same as current
Not Provided
Not Provided
 
Efficacy of Repyflec Cognitive Training for Patients With Schizophrenia
Efficacy of Repyflec Cognitive Training on Cognitive Functioning, Social Adjustment, Symptomatology and Theory of Mind of Outpatients With Schizophrenia.

Background: Cognitive difficulties are prevalent in people with a diagnosis of schizophrenia and are associated with poor long-term functioning.

Aims: To evaluate the efficacy of a Problem Solving and Cognitive Flexibility structured training program (REPYFLEC) addressed to improve the cognitive functioning, the social adjustment, the symptomatology and Theory of Mind of outpatients with schizophrenia.

Method: Participants with a diagnosis of schizophrenia (n=52) were randomised to 32 group sessions of REPYFLEC training or activities without specific objectives and focused to leisure. Social adjustment, Theory of Mind (ToM), symptoms and cognitive function, were measured at weeks 0, 8, 16 and 40. Mixed Models were conducted where 8 weeks, 16 weeks and 40 weeks assessments are dependent variables and baseline measures are covariables.

Results: Patients in the cognitive training (REPYFLEC) group demonstrated significantly improvements on social functioning (global measures, work-occupation, social relationships)and executive function (mainly planning) 6 months after finishing the treatment (following assessment at 40 weeks), compared with control group. Results in global measures of symptoms and ToM were not obtained,nevertheless, some symptoms as poor rapport shown a consistent benefit in the experimental group.

Conclusions: REPYFLEC cognitive training is associated with significant improvements on executive functions and social functioning in outpatients with schizophrenia. Intervention on executive function has shown an improvement on social functioning.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Implementation of a Cognitive Training for Schizophrenia
Behavioral: Repyflec cognitive remediation training
Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.
  • Experimental: Cognitive training
    Repyflec cognitive remediation training as a Problem solving and Cognitive flexibility training.
    Intervention: Behavioral: Repyflec cognitive remediation training
  • Active Comparator: Leisure group
    Leisure group has got same number of sessions and timing than experimental group
    Intervention: Behavioral: Repyflec cognitive remediation training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
February 2011
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Schizophrenia or Schizoaffective Disorder diagnosis
  • Illness onset at least 2 years before recruitment
  • Literate
  • Mini Mental State Exam scores over 24
  • Global Assessment of Functioning scores between 70-40

Exclusion Criteria:

  • Illness acute phase
  • Mental Disability diagnosis
  • To have neurological illness that impair cognition
  • To be receiving social skills training or cognitive remediation
  • To receive a change of antipsychotic one month before the trial or during the 40 study weeks
  • To have dependence diagnosis of alcohol or drugs 6 months before the trial.
Both
18 Years to 60 Years
No
Contact: Aida Farreny, PhD Psychol. +34 936406350 ext 12373 afarreny@pssjd.org
Contact: Judith Usall, PhD Psychia. +34 936406350 ext 12356 jusall@pssjd.org
Spain
 
NCT01279070
REPYFLEC Clinical Trial
No
Aida Farreny, Fundació Sant Joan de Déu
Fundació Sant Joan de Déu
Not Provided
Principal Investigator: Aida Farreny, PhD Psycho. Fundació Sant Joan de Déu
Fundació Sant Joan de Déu
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP