The Efficacy of REHACOP Program in Schizophrenia (CSrehacopSZ)

Implementation of REHACOP Cognitive Training Program in Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: REHACOP; Behavioral: Occupational activities

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Biskai
    • Bilbao, Biskai, Spain, 48007
      • University of Deusto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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: Rehacop group; Cognitive rehabilitation	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
Active Comparator: Control group; Occupational activities	Behavioral: Occupational activities; Occupational group activities conducted included drawing, gardening, reading the daily news and constructing using different materials (such as paper or wood).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional competence after receiving cognitive remediation	functional competence was measured with San Diego UCSD Performance-Based Skills Assessment- UPSA	4 months
Change in global functioning after receiving cognitive remediation	global functioning measured with Global Assessment of Functioning (GAF)	4 months
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in emotion perception after receiving cognitive remediation	emotion perception was assessed with Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)	4 months
change in clinical symptoms after receiving cognitive remediation	Clinical symptoms was measured with Positive and Negative Syndrome Scale (PANSS)	4 months
change in social perception after receiving cognitive remediation	Social perception was assessed with the Social Featuring Recognition Test (SFRT)	4 months
change in theory of mind after receiving cognitive remediation	Theory of mind was assessed with Happe Strange Stories Test	4 months

Collaborators and Investigators

• Sponsor: University of Deusto
• Investigators: Principal Investigator: Natalia Ojeda, PhD, University of Deusto

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Estimate): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: NSMC-003-UD