NCT02796417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

2.1 years

First QC Date

May 13, 2016

Last Update Submit

June 6, 2016

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • change in emotion perception after receiving cognitive remediation

    4 months

  • change in clinical symptoms after receiving cognitive remediation

    4 months

  • change in social perception after receiving cognitive remediation

    4 months

  • change in theory of mind after receiving cognitive remediation

    4 months

Study Arms (2)

Rehacop group

EXPERIMENTAL

Cognitive rehabilitation

Behavioral: REHACOP

Control group

ACTIVE COMPARATOR

Occupational activities

Behavioral: Occupational activities

Interventions

REHACOPBEHAVIORAL

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

Rehacop group
Occupational activitiesBEHAVIORAL

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

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnostic criteria for Schizophrenia according to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Deusto

Bilbao, Biskai, 48007, Spain

Location

Related Publications (2)

  • 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.

    PMID: 29525739DERIVED

  • 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.

    PMID: 27868083DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Natalia Ojeda, PhD

    University of Deusto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

June 10, 2016

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 10, 2016

Record last verified: 2016-06

Locations

ES(1)