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.

Study Overview

• Status: Completed
• Conditions: Indication for Modification of Patient Cognitive Status
• Intervention / Treatment: Behavioral: Repyflec cognitive remediation training

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Boi de Llobregat, Barcelona, Spain, 08930
      • Parc Sanitari Sant Joan de Déu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 training; Cognitive rehabilitation; Cognitive remediation therapy
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 training; Cognitive rehabilitation; Cognitive remediation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive Function	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.	Change from baseline in executive function at 16 weeks (post-treatment)
Executive Function	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.	Change from baseline in executive functioning at 40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial Functioning	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.	Change from baseline in social functioning scales at 16 weeks
Psychosocial Functioning	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.	Change from baseline in social functioning scales at 40 weeks
Psychiatric Symptoms	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.	Change from baseline in psychiatric symptoms scales at 16 weeks
Psychiatric Symptoms	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.	Change from baseline in psychiatric symptoms scales at 40 weeks

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Investigators: Principal Investigator: Aida Farreny, PhD Psycho., Fundació Sant Joan de Deu

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 14, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognitive remediation; Executive function; Group training; Social functioning
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: REPYFLEC Clinical Trial