<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/NCT02184481</url>
  </required_header>
  <id_info>
    <org_study_id>Franken 5</org_study_id>
    <nct_id>NCT02184481</nct_id>
  </id_info>
  <brief_title>Working Memory Training for Dysphoric Students</brief_title>
  <official_title>Working Memory Training to Decrease Depression, Anxiety and Rumination in Dysphoric Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression is associated with impairments in executive functions, including working memory&#xD;
      (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM&#xD;
      impairments depressed individuals have difficulties inhibiting and shifting from irrelevant&#xD;
      (negative) information and updating goal relevant information. This study explored whether&#xD;
      training WM decreases these impairments and reduces clinical symptoms of depression, anxiety&#xD;
      and rumination. Sixty-one students with an elevated score on the BDI-II, representing a&#xD;
      dysphoric mood state, executed a working memory training (n = 34) or placebo training (n =&#xD;
      27). Before and after training their depression, anxiety, rumination and working memory were&#xD;
      assessed. Furthermore, they executed a working memory task while their pupil dilation was&#xD;
      measured to assess their fatigue. Moreover, the investigators compared the dysphoric students&#xD;
      with a healthy student population on all measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <primary_completion_date type="Actual">June 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement</measure>
    <time_frame>Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)</time_frame>
    <description>Depression is measured with the BDI-II</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement</measure>
    <time_frame>Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)</time_frame>
    <description>The STAI measures state, trait and total anxiety</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ruminative Response Scale (RRS) score change between pre and post training</measure>
    <time_frame>Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)</time_frame>
    <description>The RRS measures rumination</description>
  </other_outcome>
  <other_outcome>
    <measure>Spanboard task</measure>
    <time_frame>Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)</time_frame>
    <description>The Spanboard task measures working memory capacity</description>
  </other_outcome>
  <other_outcome>
    <measure>N-back task</measure>
    <time_frame>Pre training (baseline), post training (6 weeks after baseline, training starts 1 day after baseline)</time_frame>
    <description>The n-back task was assessed while participants pupil dilation was measured with the eyetracker. The aim of this measurement was to measure fatigue.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Working memory training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants executed the training for three weeks, three times a week, half an hour per session. The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure. The person could become stronger when giving the right answers in eight different working memory tasks. The level adapted to the working memory capacity of the participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo training</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants executed the training for three weeks, three times a week, half an hour per session. The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure. The person could become stronger when giving the right answers in eight different working memory tasks. The level in the placebo condition was easy and did not adapt to the working memory capacity of the participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Working memory training</intervention_name>
    <arm_group_label>Working memory training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo training</intervention_name>
    <arm_group_label>Placebo training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BDI 10 of higher for dysphoric group&#xD;
&#xD;
          -  BDI 5 or lower for healthy control group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Erasmus University Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid Holland</state>
        <zip>3000 DR</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Ingmar Franken</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Working memory</keyword>
  <keyword>Rumination</keyword>
  <keyword>Cognitive training</keyword>
  <keyword>Executive functioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT02184481
org study id: Franken 5
nct id: NCT02184481
lead sponsor: 
has dmc: No
Depression is associated with impairments in executive functions, including working memory
      (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM
      impairments depressed individuals have difficulties inhibiting and shifting from irrelevant
      (negative) information and updating goal relevant information. This study explored whether
      training WM decreases these impairments and reduces clinical symptoms of depression, anxiety
      and rumination. Sixty-one students with an elevated score on the BDI-II, representing a
      dysphoric mood state, executed a working memory training (n = 34) or placebo training (n =
      27). Before and after training their depression, anxiety, rumination and working memory were
      assessed. Furthermore, they executed a working memory task while their pupil dilation was
      measured to assess their fatigue. Moreover, the investigators compared the dysphoric students
      with a healthy student population on all measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement
time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
description: Depression is measured with the BDI-II
measure: State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement
time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
description: The STAI measures state, trait and total anxiety
measure: Ruminative Response Scale (RRS) score change between pre and post training
time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
description: The RRS measures rumination
measure: Spanboard task
time frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
description: The Spanboard task measures working memory capacity
measure: N-back task
time frame: Pre training (baseline), post training (6 weeks after baseline, training starts 1 day after baseline)
description: The n-back task was assessed while participants pupil dilation was measured with the eyetracker. The aim of this measurement was to measure fatigue.
arm group label: Working memory training
arm group type: Experimental
description: Participants executed the training for three weeks, three times a week, half an hour per session. The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure. The person could become stronger when giving the right answers in eight different working memory tasks. The level adapted to the working memory capacity of the participant.
arm group label: Placebo training
arm group type: Placebo Comparator
description: Participants executed the training for three weeks, three times a week, half an hour per session. The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure. The person could become stronger when giving the right answers in eight different working memory tasks. The level in the placebo condition was easy and did not adapt to the working memory capacity of the participant.
intervention type: Behavioral
intervention name: Working memory training
arm group label: Working memory training
intervention type: Behavioral
intervention name: Placebo training
arm group label: Placebo training
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Ingmar Franken
investigator title: Professor
mesh term: Depression
mesh term: Depressive Disorder