Efficacy of Repyflec Cognitive Training for Patients With Schizophrenia
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Implementation of a Cognitive Training for Schizophrenia |
Behavioral: Repyflec cognitive remediation training |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Repyflec Cognitive Training on Cognitive Functioning, Social Adjustment, Symptomatology and Theory of Mind of Outpatients With Schizophrenia. |
- 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.
- 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.
| Estimated Enrollment: | 62 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | February 2011 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cognitive training
Repyflec cognitive remediation training as a Problem solving and Cognitive flexibility training.
|
Behavioral: Repyflec cognitive remediation training
Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.
|
|
Active Comparator: Leisure group
Leisure group has got same number of sessions and timing than experimental group
|
Behavioral: Repyflec cognitive remediation training
Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| 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 | |
| Parc Sanitari Sant Joan de Déu | Recruiting |
| Sant Boi de Llobregat, Barcelona, Spain, 08930 | |
| Principal Investigator: | Aida Farreny, PhD Psycho. | Fundació Sant Joan de Déu |
More Information
No publications provided
| Responsible Party: | Aida Farreny, Fundació Sant Joan de Déu |
| ClinicalTrials.gov Identifier: | NCT01279070 History of Changes |
| Other Study ID Numbers: | REPYFLEC Clinical Trial |
| Study First Received: | January 14, 2011 |
| Last Updated: | January 18, 2011 |
| Health Authority: | Spain: Departament de Salut de la Generalitat de Catalunya |
Keywords provided by Fundació Sant Joan de Déu:
|
Schizophrenia Cognitive remediation training |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013