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Cognitive Remediation Therapy (CRT) in Adolescents With EOS

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ClinicalTrials.gov Identifier: NCT01701609
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Centro de Investigación Biomédica en Red de Salud Mental
Information provided by (Responsible Party):
Olga Puig, Hospital Clinic of Barcelona

Study Description
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Brief Summary:
Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia improving functional outcome. But most of the studies have involved participants who are in average in their mid 30s, and little is known about the efficacy of CRT in adolescents with early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in improving cognitive performance and functional outcome in adolescents with EOS. We expect to find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive Remediation Therapy Not Applicable

Detailed Description:

Early-onset schizophrenia (EOS) is associated with worse course and poor outcome than adulthood schizophrenia. Cognitive deficits are known to be a core feature in EOS, with large deficits on almost all cognitive domains. Importantly, cognitive deficits are known to be strong predictors of psychosocial and functional outcomes in schizophrenia and also in the early-onset form of the illness. Cognitive Remediation Therapy (CRT) is a behavioral training based intervention that aims to improve cognitive processes (attention, memory, executive function, social cognition or metacognition) with the goal of durability and generalization. It has been demonstrated that CRT improve cognitive deficits and functional outcome in adult patients but there are very few studies with adolescent samples.

A controlled randomized study will be carry out with two groups: patients receiving treatment as usual plus CRT, and patients receiving treatment as usual (TAU). The independent variable is the cognitive remediation treatment. The CRT will be applied according to the manual of Wykes and Reeder (2005). The program has a duration of 40 sessions, with two session for week. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding in a context of learning without errors.

The main dependent variable is the cognitive performance measured through neuropsychological tests. Other secondary dependent variables are functional outcome and clinical symptoms obtained from the psychometric evaluation.

All participants will be evaluated before and after the experimental intervention in several neurocognitive domains, clinical symptoms and functional outcome. The evaluations will be carried out by expert evaluators. Intention-to-treat analysis will be carry out using the statistical package SPSS v 18.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Cognitive Remediation Treatment in Adolescents With Schizophrenia Spectrum Disorders
Actual Study Start Date : January 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitive Remediation Therapy
CRT: Frontal/Executive Program. The program has a duration of 40 sessions, with two session for week. Is is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding in a context of learning without errors.
 Behavioral: Cognitive Remediation Therapy
Other Names:
  • Cognitive training
  • Cognitive enhancement


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive performance [ Time Frame: 20 weeks ]
    Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation


Secondary Outcome Measures :
  1. Functional outcome [ Time Frame: 20 weeks ]
    Change in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation

  2. Symptoms [ Time Frame: 20 weeks ]
    Change from baseline in measures of clinical symptoms at post-treatment evaluation


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 12 and 18 years
  • a DSM-IV-TR schizophrenia-type disorder (schizophrenia or schizoaffective disorder), with onset before the age of 17
  • being clinically and pharmacologically stabilized during the last 6 weeks before the baseline assessment
  • the estimation of not modifying pharmacological antipsychotic treatment
  • presence of cognitive deficit confirmed by the neuropsychological battery

Exclusion Criteria:

  • IQ below 70
  • presence of an active misuse disorder
  • presence of organic brain syndromes or neurological disorders
  • having received electroconvulsive therapy in the previous 6 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701609


Locations
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Spain
Department of Child and Adolescent Pyshicatry and Psychology
Barcelona, Catalunya, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Instituto de Salud Carlos III
Centro de Investigación Biomédica en Red de Salud Mental
Investigators
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Principal Investigator: Olga Puig, PhD Hospital Clinic of Barcelona
Study Director: Rafael Penadés, PhD Hospital Clínic de Barcelona
Study Director: Josefina Castro-Fornieles, MD Hospital Clínic de Barcelona
More Information
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Publications of Results:

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Responsible Party: Olga Puig, Olga Puig Navarro, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01701609    
Other Study ID Numbers: PI07/90054
ETES07/90054 ( Other Grant/Funding Number: ISCIII )
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Keywords provided by Olga Puig, Hospital Clinic of Barcelona:
early-onset schizophrenia
adolescents
cognition
cognitive remediation therapy
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders