<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01701609</url>
  </required_header>
  <id_info>
    <org_study_id>PI07/90054</org_study_id>
    <secondary_id>ETES07/90054</secondary_id>
    <nct_id>NCT01701609</nct_id>
  </id_info>
  <brief_title>Cognitive Remediation Therapy (CRT) in Adolescents With EOS</brief_title>
  <official_title>Efficacy of a Cognitive Remediation Treatment in Adolescents With Schizophrenia Spectrum Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro de Investigación Biomédica en Red de Salud Mental</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia&#xD;
      improving functional outcome. But most of the studies have involved participants who are in&#xD;
      average in their mid 30s, and little is known about the efficacy of CRT in adolescents with&#xD;
      early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in&#xD;
      improving cognitive performance and functional outcome in adolescents with EOS. We expect to&#xD;
      find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early-onset schizophrenia (EOS) is associated with worse course and poor outcome than&#xD;
      adulthood schizophrenia. Cognitive deficits are known to be a core feature in EOS, with large&#xD;
      deficits on almost all cognitive domains. Importantly, cognitive deficits are known to be&#xD;
      strong predictors of psychosocial and functional outcomes in schizophrenia and also in the&#xD;
      early-onset form of the illness. Cognitive Remediation Therapy (CRT) is a behavioral training&#xD;
      based intervention that aims to improve cognitive processes (attention, memory, executive&#xD;
      function, social cognition or metacognition) with the goal of durability and generalization.&#xD;
      It has been demonstrated that CRT improve cognitive deficits and functional outcome in adult&#xD;
      patients but there are very few studies with adolescent samples.&#xD;
&#xD;
      A controlled randomized study will be carry out with two groups: patients receiving treatment&#xD;
      as usual plus CRT, and patients receiving treatment as usual (TAU). The independent variable&#xD;
      is the cognitive remediation treatment. The CRT will be applied according to the manual of&#xD;
      Wykes and Reeder (2005). The program has a duration of 40 sessions, with two session for&#xD;
      week. It is carried out individually and utilizes paper and pencil tasks. The main technique&#xD;
      utilized is the scaffolding in a context of learning without errors.&#xD;
&#xD;
      The main dependent variable is the cognitive performance measured through neuropsychological&#xD;
      tests. Other secondary dependent variables are functional outcome and clinical symptoms&#xD;
      obtained from the psychometric evaluation.&#xD;
&#xD;
      All participants will be evaluated before and after the experimental intervention in several&#xD;
      neurocognitive domains, clinical symptoms and functional outcome. The evaluations will be&#xD;
      carried out by expert evaluators. Intention-to-treat analysis will be carry out using the&#xD;
      statistical package SPSS v 18.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2007</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive performance</measure>
    <time_frame>20 weeks</time_frame>
    <description>Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>20 weeks</time_frame>
    <description>Change in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms</measure>
    <time_frame>20 weeks</time_frame>
    <description>Change from baseline in measures of clinical symptoms at post-treatment evaluation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Cognitive Remediation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Remediation Therapy</intervention_name>
    <arm_group_label>Cognitive Remediation Therapy</arm_group_label>
    <other_name>Cognitive training</other_name>
    <other_name>Cognitive enhancement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 12 and 18 years&#xD;
&#xD;
          -  a DSM-IV-TR schizophrenia-type disorder (schizophrenia or schizoaffective disorder),&#xD;
             with onset before the age of 17&#xD;
&#xD;
          -  being clinically and pharmacologically stabilized during the last 6 weeks before the&#xD;
             baseline assessment&#xD;
&#xD;
          -  the estimation of not modifying pharmacological antipsychotic treatment&#xD;
&#xD;
          -  presence of cognitive deficit confirmed by the neuropsychological battery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IQ below 70&#xD;
&#xD;
          -  presence of an active misuse disorder&#xD;
&#xD;
          -  presence of organic brain syndromes or neurological disorders&#xD;
&#xD;
          -  having received electroconvulsive therapy in the previous 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga Puig, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rafael Penadés, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josefina Castro-Fornieles, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Child and Adolescent Pyshicatry and Psychology</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Puig O, Penades R, Baeza I, De la Serna E, Sanchez-Gistau V, Bernardo M, Castro-Fornieles J. Cognitive remediation therapy in adolescents with early-onset schizophrenia: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):859-68. doi: 10.1016/j.jaac.2014.05.012. Epub 2014 Jun 21.</citation>
    <PMID>25062593</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Olga Puig</investigator_full_name>
    <investigator_title>Olga Puig Navarro</investigator_title>
  </responsible_party>
  <keyword>early-onset schizophrenia</keyword>
  <keyword>adolescents</keyword>
  <keyword>cognition</keyword>
  <keyword>cognitive remediation therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01701609
org study id: PI07/90054
secondary id: ETES07/90054
nct id: NCT01701609
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Cognitive performance
time frame: 20 weeks
description: Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation
measure: Functional outcome
time frame: 20 weeks
description: Change in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation
measure: Symptoms
time frame: 20 weeks
description: Change from baseline in measures of clinical symptoms at post-treatment evaluation
arm group label: Cognitive Remediation Therapy
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Cognitive Remediation Therapy
arm group label: Cognitive Remediation Therapy
other name: Cognitive training
other name: Cognitive enhancement
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Olga Puig, PhD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
last name: Rafael Penadés, PhD
role: Study Director
affiliation: Hospital Clinic of Barcelona
last name: Josefina Castro-Fornieles, MD
role: Study Director
affiliation: Hospital Clinic of Barcelona
facility: 
country: Spain
citation: Puig O, Penades R, Baeza I, De la Serna E, Sanchez-Gistau V, Bernardo M, Castro-Fornieles J. Cognitive remediation therapy in adolescents with early-onset schizophrenia: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):859-68. doi: 10.1016/j.jaac.2014.05.012. Epub 2014 Jun 21.
PMID: 25062593
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Olga Puig
investigator title: Olga Puig Navarro
mesh term: Schizophrenia