<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/NCT04400162</url>
  </required_header>
  <id_info>
    <org_study_id>248/2019BO1</org_study_id>
    <nct_id>NCT04400162</nct_id>
  </id_info>
  <brief_title>Augmentation of Depression Treatment by Gamified Network Retraining</brief_title>
  <official_title>Augmentation of Depression Treatment by Gamified Network Retraining: Feasibility, Effect Size Estimates, and User Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Major depressive disorder (MDD) is a highly prevalent and debilitating mental disorder with a&#xD;
      high lifetime prevalence of 16-20%. Particularly for people with low socio-economic status,&#xD;
      the existing and effective treatment options are hard to reach and show weaker effectivities.&#xD;
      There is a potential to ameliorate depressive symptoms and improve quality of life in persons&#xD;
      with mild-to-moderate depression by providing access to stimulating computerized trainings.&#xD;
      Single computerized trainings that target depressive symptoms have been tested in laboratory&#xD;
      and clinical settings so far. To date, innovative market access and confirmatory studies are&#xD;
      missing for a large-scale implementation of such trainings. Thereby, the present work will&#xD;
      foster a digitalized training paradigm (Paced-Auditory Serial Addition Task; PASAT) which was&#xD;
      previously shown to reduce depressive symptoms, but in a novel innovative and gamified form&#xD;
      on a tablet-PC handed out to participants. Different versions of the same training paradigm&#xD;
      that comprise additional game elements will be compared. The feasibility study will gather&#xD;
      data on effect size estimates of symptom severity reduction, user experience and usage in an&#xD;
      ecological valid setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2020</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability and feasibility on the UsExQ [User Experience Questionnaire]</measure>
    <time_frame>2-4 weeks</time_frame>
    <description>Usage frequency, performed calculations during each session and over the course of the participation. Feedback on perceived quality of the device and software. Acceptance of training and willingness to continue (open text questionnaires; usability ranging from -- to ++ on a 5 point scale with negative responses corresponding to a more negative user experience).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MADRS [Montgomery-Asberg Depression Rating Scale]</measure>
    <time_frame>18-20 weeks</time_frame>
    <description>Evaluation of depressive symptoms over the course of the intervention on the MADRS (lower numberes show decrease in depressive symptoms; range from 0-60).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)</measure>
    <time_frame>18-20 weeks</time_frame>
    <description>Changes of the score over the course of the experiment (lower numbers showing decrease of perceived wellbeing; range from 0-25).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)</measure>
    <time_frame>18-20 weeks</time_frame>
    <description>Changes of the score over the course of the experiment (lower numbers showing decrease of symptoms; range from 0-84).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RSES [Rosenberg Self Esteem Scale] (self esteem)</measure>
    <time_frame>18-20 weeks</time_frame>
    <description>Changes of the score over the course of the experiment (higher scores showing increase of self-esteem; range from 0-30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SRQ [State Rumination Questionnaire] (rumination)</measure>
    <time_frame>18-20 weeks</time_frame>
    <description>Changes of the score over the course of the experiment (lower scores showing decrease of ruminating thoughts; range from 10-50).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Depression Mild</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Cognitive Dysfunction</condition>
  <condition>Depressive Disorder</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>CCT (standard)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm consists of the CCT in a standard variant that provides the basic training experience without any added gaming elements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CCT (game)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm consists of the same CCT as the standard version, however pre-defined gaming elements that are thought to increase usability as well as interest in the intervention have been added.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usability of the CCT</intervention_name>
    <description>Evaluation of the usability of the provided training.</description>
    <arm_group_label>CCT (game)</arm_group_label>
    <arm_group_label>CCT (standard)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Changes in regards to the depressive disorder</intervention_name>
    <description>Evaluation of depressive symptoms and whether they change in regards to the provided training.</description>
    <arm_group_label>CCT (game)</arm_group_label>
    <arm_group_label>CCT (standard)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full age (&gt; 18 years old)&#xD;
&#xD;
          -  Consent&#xD;
&#xD;
          -  German mother tongue&#xD;
&#xD;
          -  Presence of mild-to-moderate depressive symptoms (MADRS &gt; 10 and &lt; 34 and confirmation&#xD;
             of depressive symptoms in M.I.N.I. diagnostic interview)&#xD;
&#xD;
          -  Stable or no medication with antidepressant drugs or other psychoactive agents (at&#xD;
             least for 6 weeks)&#xD;
&#xD;
          -  No or current psychotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of schizophrenia / psychotic disorder (according to M.I.N.I. diagnostic&#xD;
             interview)&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Plewnia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tübingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychiatry and Psychotherapy, University of Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 9, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Christian Plewnia, MD</investigator_full_name>
    <investigator_title>Doctor of Psychiatry and Psychotherapy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT04400162
org study id: 248/2019BO1
nct id: NCT04400162
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Major depressive disorder (MDD) is a highly prevalent and debilitating mental disorder with a
      high lifetime prevalence of 16-20%. Particularly for people with low socio-economic status,
      the existing and effective treatment options are hard to reach and show weaker effectivities.
      There is a potential to ameliorate depressive symptoms and improve quality of life in persons
      with mild-to-moderate depression by providing access to stimulating computerized trainings.
      Single computerized trainings that target depressive symptoms have been tested in laboratory
      and clinical settings so far. To date, innovative market access and confirmatory studies are
      missing for a large-scale implementation of such trainings. Thereby, the present work will
      foster a digitalized training paradigm (Paced-Auditory Serial Addition Task; PASAT) which was
      previously shown to reduce depressive symptoms, but in a novel innovative and gamified form
      on a tablet-PC handed out to participants. Different versions of the same training paradigm
      that comprise additional game elements will be compared. The feasibility study will gather
      data on effect size estimates of symptom severity reduction, user experience and usage in an
      ecological valid setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Usability and feasibility on the UsExQ [User Experience Questionnaire]
time frame: 2-4 weeks
description: Usage frequency, performed calculations during each session and over the course of the participation. Feedback on perceived quality of the device and software. Acceptance of training and willingness to continue (open text questionnaires; usability ranging from -- to ++ on a 5 point scale with negative responses corresponding to a more negative user experience).
measure: MADRS [Montgomery-Asberg Depression Rating Scale]
time frame: 18-20 weeks
description: Evaluation of depressive symptoms over the course of the intervention on the MADRS (lower numberes show decrease in depressive symptoms; range from 0-60).
measure: WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)
time frame: 18-20 weeks
description: Changes of the score over the course of the experiment (lower numbers showing decrease of perceived wellbeing; range from 0-25).
measure: IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)
time frame: 18-20 weeks
description: Changes of the score over the course of the experiment (lower numbers showing decrease of symptoms; range from 0-84).
measure: RSES [Rosenberg Self Esteem Scale] (self esteem)
time frame: 18-20 weeks
description: Changes of the score over the course of the experiment (higher scores showing increase of self-esteem; range from 0-30).
measure: SRQ [State Rumination Questionnaire] (rumination)
time frame: 18-20 weeks
description: Changes of the score over the course of the experiment (lower scores showing decrease of ruminating thoughts; range from 10-50).
arm group label: CCT (standard)
arm group type: Active Comparator
description: This arm consists of the CCT in a standard variant that provides the basic training experience without any added gaming elements.
arm group label: CCT (game)
arm group type: Experimental
description: This arm consists of the same CCT as the standard version, however pre-defined gaming elements that are thought to increase usability as well as interest in the intervention have been added.
intervention type: Behavioral
intervention name: Usability of the CCT
description: Evaluation of the usability of the provided training.
arm group label: CCT (game)
arm group label: CCT (standard)
intervention type: Behavioral
intervention name: Changes in regards to the depressive disorder
description: Evaluation of depressive symptoms and whether they change in regards to the provided training.
arm group label: CCT (game)
arm group label: CCT (standard)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Plewnia, MD
role: Principal Investigator
affiliation: University Hospital Tübingen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Christian Plewnia, MD
investigator title: Doctor of Psychiatry and Psychotherapy
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Cognitive Dysfunction
sharing ipd: Undecided