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
  Purpose

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.


Condition Intervention Phase
Indication for Modification of Patient Cognitive Status
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 Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Fundació Sant Joan de Déu:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 62
Study Start Date: September 2006
Study Completion Date: March 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REPYFLEC cognitive remediation training
REPYFLEC cognitive remediation as a Problem solving and Cognitive flexibility group training.
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
Active Comparator: Leisure group
Leisure group is a stimulating activity focused on socialization through group dynamics, board games, "coffee and talk".
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279070

Locations
Spain
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, Spain, 08930
Sponsors and Collaborators
Fundació Sant Joan de Déu
Investigators
Principal Investigator: Aida Farreny, PhD Psycho. Fundació Sant Joan de Déu
  More Information

No publications provided

Responsible Party: Aida Farreny, Dr. 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
Results First Received: November 16, 2011
Last Updated: August 14, 2013
Health Authority: Spain: Departament de Salut de la Generalitat de Catalunya

Keywords provided by Fundació Sant Joan de Déu:
Schizophrenia
Cognitive remediation
Group training
Executive function
Social functioning

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014