Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aida Farreny, Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT01279070
First received: January 14, 2011
Last updated: August 14, 2013
Last verified: May 2013

January 14, 2011
August 14, 2013
September 2006
January 2009   (final data collection date for primary outcome measure)
  • Executive Function [ Time Frame: Change from baseline in executive function at 16 weeks (post-treatment) ] [ Designated as safety issue: No ]

    Behavioral Assessment of the Dysexecutive Syndrome (BADS). 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 judgment, 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.

  • Executive Function [ Time Frame: Change from baseline in executive functioning at 40 weeks ] [ Designated as safety issue: No ]

    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.

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.
Complete list of historical versions of study NCT01279070 on ClinicalTrials.gov Archive Site
  • Psychosocial Functioning [ Time Frame: Change from baseline in social functioning scales at 16 weeks ] [ Designated as safety issue: No ]

    The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39-max. 156) with a higher score indicating a better result.

    The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0-max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation.

  • Psychosocial Functioning [ Time Frame: Change from baseline in social functioning scales at 40 weeks ] [ Designated as safety issue: No ]

    The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39-max. 156) with a higher score indicating a better result.

    The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0-max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation.

  • Psychiatric Symptoms [ Time Frame: Change from baseline in psychiatric symptoms scales at 16 weeks ] [ Designated as safety issue: No ]
    The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30-max. 210) with a score of 30 representing an absence of psychiatric symptoms.
  • Psychiatric Symptoms [ Time Frame: Change from baseline in psychiatric symptoms scales at 40 weeks ] [ Designated as safety issue: No ]
    The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30-max. 210) with a score of 30 representing an absence of psychiatric symptoms.
  • 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.
Not Provided
Not Provided
 
Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia
Efficacy of Repyflec Cognitive Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Indication for Modification of Patient Cognitive Status
Behavioral: Repyflec cognitive remediation training
Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.
Other Names:
  • Cognitive remediation therapy
  • Cognitive rehabilitation
  • Cognitive training
  • Experimental: REPYFLEC cognitive remediation training
    REPYFLEC cognitive remediation as a Problem solving and Cognitive flexibility group training.
    Intervention: Behavioral: Repyflec cognitive remediation training
  • Active Comparator: Leisure group
    Leisure group is a stimulating activity focused on socialization through group dynamics, board games, "coffee and talk".
    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.
 
Completed
62
March 2011
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • More than 2 years illness duration
  • Literate
  • 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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
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
May 2013

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