The Efficacy of REHACOP Program in Schizophrenia

Schizophrenia Clinical Trial

— CSrehacopSZ  

Official title:

Implementation of REHACOP Cognitive Training Program in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796417
• Other study ID #: NSMC-003-UD
• Status: Completed
• Phase: N/A
• First received: May 13, 2016
• Last updated: June 6, 2016
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2016
• Source: University of Deusto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• REHACOP
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
• Occupational activities
Occupational group activities conducted included drawing, gardening, reading the daily news and constructing using different materials (such as paper or wood).

Locations

Country	Name	City	State
Spain	University of Deusto	Bilbao	Biskai

Sponsors (1)

Lead Sponsor	Collaborator
University of Deusto

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional competence after receiving cognitive remediation	functional competence was measured with San Diego UCSD Performance-Based Skills Assessment- UPSA	4 months	Yes
Primary	Change in global functioning after receiving cognitive remediation	global functioning measured with Global Assessment of Functioning (GAF)	4 months	Yes
Primary	change in verbal memory after receiving cognitive remediation	Verbal memory performance was assessed with the Hopkins Verbal Learning Test-HVLT (Brandt and Benedict 2001)	4 months	Yes
Primary	change in processing speed after receiving cognitive remediation	Processing speed was assessed with Digit Symbol subtest from Wechsler Adult Intelligence Scale-III (Wechsler 1997)	4 months	Yes
Secondary	change in emotion perception after receiving cognitive remediation	emotion perception was assessed with Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)	4 months	Yes
Secondary	change in clinical symptoms after receiving cognitive remediation	Clinical symptoms was measured with Positive and Negative Syndrome Scale (PANSS)	4 months	Yes
Secondary	change in social perception after receiving cognitive remediation	Social perception was assessed with the Social Featuring Recognition Test (SFRT)	4 months	Yes
Secondary	change in theory of mind after receiving cognitive remediation	Theory of mind was assessed with Happe Strange Stories Test	4 months	Yes