search
Back to results

Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

Primary Purpose

Indication for Modification of Patient Cognitive Status

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Repyflec cognitive remediation training
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indication for Modification of Patient Cognitive Status focused on measuring Schizophrenia, Cognitive remediation, Group training, Executive function, Social functioning

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Parc Sanitari Sant Joan de Déu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REPYFLEC cognitive remediation training

Leisure group

Arm Description

REPYFLEC cognitive remediation as a Problem solving and Cognitive flexibility group training.

Leisure group is a stimulating activity focused on socialization through group dynamics, board games, "coffee and talk".

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 14, 2011
Last Updated
August 14, 2013
Sponsor
Fundació Sant Joan de Déu
search

1. Study Identification

Unique Protocol Identification Number
NCT01279070
Brief Title
Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia
Official Title
Efficacy of Repyflec Cognitive Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundació Sant Joan de Déu

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indication for Modification of Patient Cognitive Status
Keywords
Schizophrenia, Cognitive remediation, Group training, Executive function, Social functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REPYFLEC cognitive remediation training
Arm Type
Experimental
Arm Description
REPYFLEC cognitive remediation as a Problem solving and Cognitive flexibility group training.
Arm Title
Leisure group
Arm Type
Active Comparator
Arm Description
Leisure group is a stimulating activity focused on socialization through group dynamics, board games, "coffee and talk".
Intervention Type
Behavioral
Intervention Name(s)
Repyflec cognitive remediation training
Other Intervention Name(s)
Cognitive remediation therapy, Cognitive rehabilitation, Cognitive training
Intervention Description
Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.
Primary Outcome Measure Information:
Title
Executive Function
Description
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.
Time Frame
Change from baseline in executive function at 16 weeks (post-treatment)
Title
Executive Function
Description
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.
Time Frame
Change from baseline in executive functioning at 40 weeks
Secondary Outcome Measure Information:
Title
Psychosocial Functioning
Description
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.
Time Frame
Change from baseline in social functioning scales at 16 weeks
Title
Psychosocial Functioning
Description
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.
Time Frame
Change from baseline in social functioning scales at 40 weeks
Title
Psychiatric Symptoms
Description
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.
Time Frame
Change from baseline in psychiatric symptoms scales at 16 weeks
Title
Psychiatric Symptoms
Description
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.
Time Frame
Change from baseline in psychiatric symptoms scales at 40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aida Farreny, PhD Psycho.
Organizational Affiliation
Fundació Sant Joan de Déu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc Sanitari Sant Joan de Déu
City
Sant Boi de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08930
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

We'll reach out to this number within 24 hrs