<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/NCT02201888</url>
  </required_header>
  <id_info>
    <org_study_id>PR-2009-15</org_study_id>
    <secondary_id>PI09/90483</secondary_id>
    <nct_id>NCT02201888</nct_id>
  </id_info>
  <brief_title>Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study</brief_title>
  <official_title>Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salvador Sarró, MD</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>
    <collaborator>
      <agency>Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>FIDMAG Germanes Hospitalàries</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence&#xD;
      suggests has consequences for functional adaptation and which cause difficulties in social&#xD;
      re-integration after hospitalization. The investigators propose a large scale, multicentric&#xD;
      study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed&#xD;
      at answering outstanding questions concerning the effectiveness of cognitive estimulation&#xD;
      therapy for schizophrenic cognitive impairment. Specifically, the study will examine a)&#xD;
      issues related to the size of the effect compared to treatment as usual and compared to a&#xD;
      control intervention; b) generalizability of improvement to cognitive function and social&#xD;
      cognition in daily life; and c) the durability of therapeutic gains after the end of&#xD;
      treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three&#xD;
      treatment conditions: a computer- assisted cognitive estimulation program (n=64),&#xD;
      non-structured time on computer (n=64) and treatment as usual (n=64). A battery of&#xD;
      neurocognitive tests of memory and executive function, including 'ecologically valid'&#xD;
      measures, will be administered by blind evaluators at baseline, after 6 months of cognitive&#xD;
      estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will&#xD;
      be also be assessed at baseline, after the treatment and at follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Memory test battery</measure>
    <time_frame>Six months</time_frame>
    <description>memory test battery Rivermead Behavioural Memory Test (RBMT)(Wilson, 1985) a memory test battery and the executive test battery, the Behavioural Assessment of the Dysexecutive Syndrome (BADS)(Wilson, 1996)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Computer-assisted cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention (4 minutes), attention/perception (5 minutes), working memory (8 minutes), auditory and visual memory (8 minutes), executive function (10 minutes), language (6 minutes), and games (4 minutes).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computerized active condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients allocated to this condition completed the same number of sessions as the cognitive training group but followed a computerized typing program (www.rapidtyping.com). This had similar design characteristics to the CRT condition, in that it was hierarchically organized with exercise level of difficulty being adjusted to the individual's level of performance and feedback being given at the end of each exercise. Additionally, patients in this condition played computerized games requiring typing (crosswords, word puzzles, etc) and were taught basic internet navigation by a supervisor. Exposure to the computer was of equivalent duration to the CRT condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer-assisted cognitive training</intervention_name>
    <description>Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.</description>
    <arm_group_label>Computer-assisted cognitive training</arm_group_label>
    <other_name>Computer-assisted cognitive training (CRT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computerized active condition</intervention_name>
    <description>Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.</description>
    <arm_group_label>Computerized active condition</arm_group_label>
    <other_name>Computerized active condition (CC)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual (TAU)</intervention_name>
    <description>TAU: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities.</description>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  schizophrenia or schizoaffective disorder fulfilling the Diagnostic and Statistical&#xD;
             Manual of Mental Disorders (DSM-IV) criteria diagnosis&#xD;
&#xD;
          -  estimated premorbid intelligence quotient (IQ) in the normal range&#xD;
&#xD;
          -  chronic illness (i.e. duration ≥two years)&#xD;
&#xD;
          -  relative clinical stability (i.e. the patients had not experienced any recent&#xD;
             exacerbation of symptoms).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of brain trauma&#xD;
&#xD;
          -  alcohol or substance abuse/dependence within the previous six months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter J McKenna, MD</last_name>
    <role>Study Director</role>
    <affiliation>FIDMAG Germanes Hospitalàries Research Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jesus J Gomar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FIDMAG Germanes Hospitalàries Research Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edith Pomarol-Clotet, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>FIDMAG Germanes Hospitalàries Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FIDMAG Germanes Hospitalàries Research Foundation</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>FIDMAG Germanes Hospitalàries</investigator_affiliation>
    <investigator_full_name>Salvador Sarró, MD</investigator_full_name>
    <investigator_title>Chief administrator</investigator_title>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Cognition</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/NCT02201888
org study id: PR-2009-15
secondary id: PI09/90483
nct id: NCT02201888
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence
      suggests has consequences for functional adaptation and which cause difficulties in social
      re-integration after hospitalization. The investigators propose a large scale, multicentric
      study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed
      at answering outstanding questions concerning the effectiveness of cognitive estimulation
      therapy for schizophrenic cognitive impairment. Specifically, the study will examine a)
      issues related to the size of the effect compared to treatment as usual and compared to a
      control intervention; b) generalizability of improvement to cognitive function and social
      cognition in daily life; and c) the durability of therapeutic gains after the end of
      treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three
      treatment conditions: a computer- assisted cognitive estimulation program (n=64),
      non-structured time on computer (n=64) and treatment as usual (n=64). A battery of
      neurocognitive tests of memory and executive function, including 'ecologically valid'
      measures, will be administered by blind evaluators at baseline, after 6 months of cognitive
      estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will
      be also be assessed at baseline, after the treatment and at follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Memory test battery
time frame: Six months
description: memory test battery Rivermead Behavioural Memory Test (RBMT)(Wilson, 1985) a memory test battery and the executive test battery, the Behavioural Assessment of the Dysexecutive Syndrome (BADS)(Wilson, 1996)
arm group label: Computer-assisted cognitive training
arm group type: Experimental
description: Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention (4 minutes), attention/perception (5 minutes), working memory (8 minutes), auditory and visual memory (8 minutes), executive function (10 minutes), language (6 minutes), and games (4 minutes).
arm group label: Computerized active condition
arm group type: Active Comparator
description: Patients allocated to this condition completed the same number of sessions as the cognitive training group but followed a computerized typing program (www.rapidtyping.com). This had similar design characteristics to the CRT condition, in that it was hierarchically organized with exercise level of difficulty being adjusted to the individual's level of performance and feedback being given at the end of each exercise. Additionally, patients in this condition played computerized games requiring typing (crosswords, word puzzles, etc) and were taught basic internet navigation by a supervisor. Exposure to the computer was of equivalent duration to the CRT condition.
arm group label: Treatment as usual
arm group type: Placebo Comparator
description: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities
intervention type: Behavioral
intervention name: Computer-assisted cognitive training
description: Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
arm group label: Computer-assisted cognitive training
other name: Computer-assisted cognitive training (CRT)
intervention type: Other
intervention name: Computerized active condition
description: Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
arm group label: Computerized active condition
other name: Computerized active condition (CC)
intervention type: Other
intervention name: Treatment as usual (TAU)
description: TAU: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities.
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Peter J McKenna, MD
role: Study Director
affiliation: FIDMAG Germanes Hospitalàries Research Foundation
last name: Jesus J Gomar, PhD
role: Principal Investigator
affiliation: FIDMAG Germanes Hospitalàries Research Foundation
last name: Edith Pomarol-Clotet, MD, PhD
role: Study Chair
affiliation: FIDMAG Germanes Hospitalàries Research Foundation
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: FIDMAG Germanes Hospitalàries
investigator full name: Salvador Sarró, MD
investigator title: Chief administrator
mesh term: Schizophrenia