<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/NCT04463914</url>
  </required_header>
  <id_info>
    <org_study_id>00096156</org_study_id>
    <secondary_id>5R42MH108219-04</secondary_id>
    <nct_id>NCT04463914</nct_id>
  </id_info>
  <brief_title>Evaluation of a Mobile Therapy for Elevated Depressive Symptoms</brief_title>
  <official_title>Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</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>
      The purpose of this research study is to evaluate a mobile application (app) for depression&#xD;
      treatment. Participants will be randomly assigned to either receive the mobile app,&#xD;
      &quot;Moodivate&quot;, or not. If provided with Moodivate, participants will be asked to use the app&#xD;
      regularly, at least once per day, throughout the study duration. Participants will be asked&#xD;
      to complete electronic questionnaire measures throughout the study period. Participation in&#xD;
      this study will take about 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">October 12, 2021</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Score of Depressive Symptoms</measure>
    <time_frame>Between baseline and week 12</time_frame>
    <description>Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">650</enrollment>
  <condition>Depressive Symptoms</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Group A- Treatment as Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in the treatment as usual group will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B- Moodivate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood. Participants in the Moodivate group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C- Moodivate + EHR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the Moodivate + EHR condition will receive similar instructions as those randomized to Moodivate, but will also be instructed that their PCP will have access to metrics related to their app utilization and may choose to follow-up with them regarding treatment utilization and response. The PCP for each participant randomized to this condition will be provided EHR access to Moodivate metrics which will include metrics related to change in mood, frequency of app utilization, and frequency of activity completion. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Activation Therapy app</intervention_name>
    <description>Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.</description>
    <arm_group_label>Group B- Moodivate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Activation Therapy app + EHR</intervention_name>
    <description>Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. The participant's primary care provider at MUSC will be provided access to a Moodivate provider portal that was developed by study team. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.</description>
    <arm_group_label>Group C- Moodivate + EHR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Participants will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.</description>
    <arm_group_label>Group A- Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elevated depressive symptoms, defined as a score of &gt; 10 on the Patient Health&#xD;
             Questionnaire-9 (PHQ-9)57&#xD;
&#xD;
          -  Age 18+&#xD;
&#xD;
          -  Currently own an iOS- or Android-compatible smartphone&#xD;
&#xD;
          -  Report willingness to utilize a mobile app for the treatment of depressed mood&#xD;
             (response of &quot;yes&quot; on yes/no item)&#xD;
&#xD;
          -  Have a current, valid e-mail address that is checked at least once per day or have&#xD;
             regular access to text messages (to access follow-up assessments)&#xD;
&#xD;
          -  Enrolled in Epic's MyChart program&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Current suicidal ideation at study screening, defined as a response &gt;1 (several days) on&#xD;
        item nine of the PHQ-9 (&quot;Over the last two weeks, how often have you been bothered by&#xD;
        thoughts that you would be better off dead, or of hurting yourself?&quot;)&#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>Jennifer Dahne, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Jennifer Dahne</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04463914
org study id: 00096156
secondary id: 5R42MH108219-04
nct id: NCT04463914
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to evaluate a mobile application (app) for depression
      treatment. Participants will be randomly assigned to either receive the mobile app,
      "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app
      regularly, at least once per day, throughout the study duration. Participants will be asked
      to complete electronic questionnaire measures throughout the study period. Participation in
      this study will take about 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Score of Depressive Symptoms
time frame: Between baseline and week 12
description: Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.
arm group label: Group A- Treatment as Usual
arm group type: Other
description: Participants in the treatment as usual group will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
arm group label: Group B- Moodivate
arm group type: Experimental
description: Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood. Participants in the Moodivate group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
arm group label: Group C- Moodivate + EHR
arm group type: Experimental
description: Participants randomized to the Moodivate + EHR condition will receive similar instructions as those randomized to Moodivate, but will also be instructed that their PCP will have access to metrics related to their app utilization and may choose to follow-up with them regarding treatment utilization and response. The PCP for each participant randomized to this condition will be provided EHR access to Moodivate metrics which will include metrics related to change in mood, frequency of app utilization, and frequency of activity completion. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
intervention type: Behavioral
intervention name: Behavioral Activation Therapy app
description: Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
arm group label: Group B- Moodivate
intervention type: Behavioral
intervention name: Behavioral Activation Therapy app + EHR
description: Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. The participant's primary care provider at MUSC will be provided access to a Moodivate provider portal that was developed by study team. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
arm group label: Group C- Moodivate + EHR
intervention type: Behavioral
intervention name: Treatment as Usual
description: Participants will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
arm group label: Group A- Treatment as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Dahne, PhD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Jennifer Dahne
investigator title: Assistant Professor
mesh term: Depression
sharing ipd: No