<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/NCT03278756</url>
  </required_header>
  <id_info>
    <org_study_id>B/14730/RMD</org_study_id>
    <nct_id>NCT03278756</nct_id>
  </id_info>
  <brief_title>Online Cognitive Control Training for Remitted Depressed Patients</brief_title>
  <official_title>Online Cognitive Control Training for Remitted Depressed Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effectiveness of an internet-delivered cognitive control training as&#xD;
      a preventive intervention for remitted depressed patients. Half of the participants will&#xD;
      receive a cognitive control training, while the other half will receive a low cognitive load&#xD;
      training that acts as an active control condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective studies have linked impaired cognitive control to increased cognitive&#xD;
      vulnerability for future depression. Importantly, experimental studies indicate that&#xD;
      cognitive control training can be used to reduce rumination and depressive symptomatology in&#xD;
      MDD (major depressive disorder) and RMD (remitted depressed) samples. Provided that remitted&#xD;
      depressed patients form a high-risk group for developing future depressive episodes, the&#xD;
      current study will explore whether an internet-delivered cognitive control training can be&#xD;
      used to reduce vulnerability for future depression in remitted depressed patients.&#xD;
&#xD;
      A computer training, consisting of 10 sessions of 15 minutes each, will be administered to&#xD;
      participants, which are remitted depressed patients. This training can either be a cognitive&#xD;
      control training, using an adaptive paced auditory serial addition task, or an active control&#xD;
      training, with a low cognitive load task.&#xD;
&#xD;
      Dependent variables will be assessed pre- and post-training, as well as 3 and 6 months after&#xD;
      the training, and consist of depressive symptomatology, related variables and cognitive&#xD;
      control measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">March 13, 2019</completion_date>
  <primary_completion_date type="Actual">March 13, 2019</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>
    <intervention_model_description>Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depressive symptomatology</measure>
    <time_frame>Assessed at pre-training assessment and at 6 months follow-up</time_frame>
    <description>Measured by the Beck Depression Inventory - II (BDI-II)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depressive symptomatology</measure>
    <time_frame>Assessed at pre-training assessment, at post-training assessment (within 1 week of completing the training), at 3 months follow-up and at 6 months follow-up</time_frame>
    <description>Measured by the Depression Anxiety Stress Scales (DASS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depressive rumination (brooding)</measure>
    <time_frame>Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up</time_frame>
    <description>Measured by the Ruminative Response Scale (RRS), especially the brooding subscale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive emotion regulation strategies</measure>
    <time_frame>Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up</time_frame>
    <description>Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up</time_frame>
    <description>Measured by the Quality of Life in Depression Scale (QLDS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission from depression</measure>
    <time_frame>Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up</time_frame>
    <description>Measured by the Remission of Depression Questionnaire (RDQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up</time_frame>
    <description>Measured by the Connor-Davidson Resilience Scale (CD-RISC)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>User engagement</measure>
    <time_frame>Assessed at post-training assessment (within 1 week of completing the training) and at 3 months follow-up</time_frame>
    <description>Measured by the User Engagement Scale (UES)</description>
  </other_outcome>
  <other_outcome>
    <measure>Threatening experiences</measure>
    <time_frame>Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up</time_frame>
    <description>Measured by the List of Threatening Experiences (LTE)</description>
  </other_outcome>
  <other_outcome>
    <measure>Effortful control</measure>
    <time_frame>Assessed at pre-training assessment and at 6 months follow-up</time_frame>
    <description>Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Credibility and Expectancy</measure>
    <time_frame>Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up</time_frame>
    <description>Measured by the Credibility/Expectancy Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Behavioral measure for cognitive control</measure>
    <time_frame>Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up</time_frame>
    <description>Measured by the non-adaptive Paced Auditory Serial Addition Task (PASAT)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Major Depression in Remission</condition>
  <arm_group>
    <arm_group_label>Cognitive Control Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A cognitive control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive paced auditory serial addition task, where participants need to click on the sum of the last two heard digits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Control Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An active control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive low load cognitive task, where participants need to click on the last heard digit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive control training</intervention_name>
    <description>10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.</description>
    <arm_group_label>Cognitive Control Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active control training</intervention_name>
    <description>10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.</description>
    <arm_group_label>Active Control Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of ≥ 1 depressive episodes (major or bipolar)&#xD;
&#xD;
          -  Currently in stable full or partial remission (≥ 3 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major depressive disorder (current or less than 3 months in remission)&#xD;
&#xD;
          -  Bipolar disorder (current or less than 3 months in remission)&#xD;
&#xD;
          -  Psychotic disorder (current and/or previous)&#xD;
&#xD;
          -  Neurological impairments (current and/or previous)&#xD;
&#xD;
          -  Excessive substance abuse (current and/or previous)&#xD;
&#xD;
          -  No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a&#xD;
             frequency of less than once every three weeks)&#xD;
&#xD;
          -  Use of antidepressant medication is allowed if kept at a constant level&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ernst HW Koster, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Remission</keyword>
  <keyword>Relapse prevention</keyword>
  <keyword>Cognitive control training</keyword>
  <keyword>Internet intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03278756
org study id: B/14730/RMD
nct id: NCT03278756
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectiveness of an internet-delivered cognitive control training as
      a preventive intervention for remitted depressed patients. Half of the participants will
      receive a cognitive control training, while the other half will receive a low cognitive load
      training that acts as an active control condition.
Prospective studies have linked impaired cognitive control to increased cognitive
      vulnerability for future depression. Importantly, experimental studies indicate that
      cognitive control training can be used to reduce rumination and depressive symptomatology in
      MDD (major depressive disorder) and RMD (remitted depressed) samples. Provided that remitted
      depressed patients form a high-risk group for developing future depressive episodes, the
      current study will explore whether an internet-delivered cognitive control training can be
      used to reduce vulnerability for future depression in remitted depressed patients.

      A computer training, consisting of 10 sessions of 15 minutes each, will be administered to
      participants, which are remitted depressed patients. This training can either be a cognitive
      control training, using an adaptive paced auditory serial addition task, or an active control
      training, with a low cognitive load task.

      Dependent variables will be assessed pre- and post-training, as well as 3 and 6 months after
      the training, and consist of depressive symptomatology, related variables and cognitive
      control measures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in depressive symptomatology
time frame: Assessed at pre-training assessment and at 6 months follow-up
description: Measured by the Beck Depression Inventory - II (BDI-II)
measure: Change in depressive symptomatology
time frame: Assessed at pre-training assessment, at post-training assessment (within 1 week of completing the training), at 3 months follow-up and at 6 months follow-up
description: Measured by the Depression Anxiety Stress Scales (DASS)
measure: Change in depressive rumination (brooding)
time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
description: Measured by the Ruminative Response Scale (RRS), especially the brooding subscale
measure: Change in cognitive emotion regulation strategies
time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
description: Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)
measure: Change in quality of life
time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
description: Measured by the Quality of Life in Depression Scale (QLDS)
measure: Remission from depression
time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
description: Measured by the Remission of Depression Questionnaire (RDQ)
measure: Resilience
time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
description: Measured by the Connor-Davidson Resilience Scale (CD-RISC)
measure: User engagement
time frame: Assessed at post-training assessment (within 1 week of completing the training) and at 3 months follow-up
description: Measured by the User Engagement Scale (UES)
measure: Threatening experiences
time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
description: Measured by the List of Threatening Experiences (LTE)
measure: Effortful control
time frame: Assessed at pre-training assessment and at 6 months follow-up
description: Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ)
measure: Credibility and Expectancy
time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
description: Measured by the Credibility/Expectancy Questionnaire
measure: Behavioral measure for cognitive control
time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
description: Measured by the non-adaptive Paced Auditory Serial Addition Task (PASAT)
arm group label: Cognitive Control Training
arm group type: Experimental
description: A cognitive control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive paced auditory serial addition task, where participants need to click on the sum of the last two heard digits.
arm group label: Active Control Training
arm group type: Active Comparator
description: An active control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive low load cognitive task, where participants need to click on the last heard digit.
intervention type: Behavioral
intervention name: Cognitive control training
description: 10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.
arm group label: Cognitive Control Training
intervention type: Behavioral
intervention name: Active control training
description: 10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.
arm group label: Active Control Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ernst HW Koster, PhD
role: Principal Investigator
affiliation: University Ghent
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Depression
sharing ipd: Undecided