Back to resultsThe Efficacy of REHACOP Program in Schizophrenia (CSrehacopSZ)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
REHACOP
Occupational activities
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- diagnostic criteria for Schizophrenia according to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Exclusion Criteria:
- evidence of alcohol or drug abuse in the last 30 days
- previous history of significant lack of consciousness
- mental retardation
- relevant neurological or medical condition
Sites / Locations
- University of Deusto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehacop group
Control group
Arm Description
Cognitive rehabilitation
Occupational activities
Outcomes
Primary Outcome Measures
Change in functional competence after receiving cognitive remediation
functional competence was measured with San Diego UCSD Performance-Based Skills Assessment- UPSA
Change in global functioning after receiving cognitive remediation
global functioning measured with Global Assessment of Functioning (GAF)
change in verbal memory after receiving cognitive remediation
Verbal memory performance was assessed with the Hopkins Verbal Learning Test-HVLT (Brandt and Benedict 2001)
change in processing speed after receiving cognitive remediation
Processing speed was assessed with Digit Symbol subtest from Wechsler Adult Intelligence Scale-III (Wechsler 1997)
Secondary Outcome Measures
change in emotion perception after receiving cognitive remediation
emotion perception was assessed with Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
change in clinical symptoms after receiving cognitive remediation
Clinical symptoms was measured with Positive and Negative Syndrome Scale (PANSS)
change in social perception after receiving cognitive remediation
Social perception was assessed with the Social Featuring Recognition Test (SFRT)
change in theory of mind after receiving cognitive remediation
Theory of mind was assessed with Happe Strange Stories Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02796417
Brief Title
The Efficacy of REHACOP Program in Schizophrenia
Acronym
CSrehacopSZ
Official Title
Implementation of REHACOP Cognitive Training Program in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Deusto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to improve cognition, social cognition, clinical symptoms and functional outcome in patients with schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehacop group
Arm Type
Experimental
Arm Description
Cognitive rehabilitation
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Occupational activities
Intervention Type
Behavioral
Intervention Name(s)
REHACOP
Intervention Description
REHACOP group consists of 90-minute-long sessions 3 days per week. Specifically, REHACOP group remediation consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas
Intervention Type
Behavioral
Intervention Name(s)
Occupational activities
Intervention Description
Occupational group activities conducted included drawing, gardening, reading the daily news and constructing using different materials (such as paper or wood).
Primary Outcome Measure Information:
Title
Change in functional competence after receiving cognitive remediation
Description
functional competence was measured with San Diego UCSD Performance-Based Skills Assessment- UPSA
Time Frame
4 months
Title
Change in global functioning after receiving cognitive remediation
Description
global functioning measured with Global Assessment of Functioning (GAF)
Time Frame
4 months
Title
change in verbal memory after receiving cognitive remediation
Description
Verbal memory performance was assessed with the Hopkins Verbal Learning Test-HVLT (Brandt and Benedict 2001)
Time Frame
4 months
Title
change in processing speed after receiving cognitive remediation
Description
Processing speed was assessed with Digit Symbol subtest from Wechsler Adult Intelligence Scale-III (Wechsler 1997)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
change in emotion perception after receiving cognitive remediation
Description
emotion perception was assessed with Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Time Frame
4 months
Title
change in clinical symptoms after receiving cognitive remediation
Description
Clinical symptoms was measured with Positive and Negative Syndrome Scale (PANSS)
Time Frame
4 months
Title
change in social perception after receiving cognitive remediation
Description
Social perception was assessed with the Social Featuring Recognition Test (SFRT)
Time Frame
4 months
Title
change in theory of mind after receiving cognitive remediation
Description
Theory of mind was assessed with Happe Strange Stories Test
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnostic criteria for Schizophrenia according to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Exclusion Criteria:
evidence of alcohol or drug abuse in the last 30 days
previous history of significant lack of consciousness
mental retardation
relevant neurological or medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Ojeda, PhD
Organizational Affiliation
University of Deusto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Deusto
City
Bilbao
State/Province
Biskai
ZIP/Postal Code
48007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29525739
Citation
Pena J, Ibarretxe-Bilbao N, Sanchez P, Uriarte JJ, Elizagarate E, Gutierrez M, Ojeda N. Mechanisms of functional improvement through cognitive rehabilitation in schizophrenia. J Psychiatr Res. 2018 Jun;101:21-27. doi: 10.1016/j.jpsychires.2018.03.002. Epub 2018 Mar 6.
Results Reference
derived
PubMed Identifier
27868083
Citation
Pena J, Ibarretxe-Bilbao N, Sanchez P, Iriarte MB, Elizagarate E, Garay MA, Gutierrez M, Iribarren A, Ojeda N. Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial. NPJ Schizophr. 2016 Nov 9;2:16037. doi: 10.1038/npjschz.2016.37. eCollection 2016.
Results Reference
derived
Learn more about this trial
The Efficacy of REHACOP Program in Schizophrenia
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