<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/NCT04502186</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00176192</org_study_id>
    <secondary_id>K01MH110605</secondary_id>
    <nct_id>NCT04502186</nct_id>
  </id_info>
  <brief_title>A Systems-Level Intervention for Rural Adults With Depression</brief_title>
  <official_title>A Systems-Level Intervention for Rural Adults With Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</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 aims to test the effectiveness of a computer-assisted cognitive behavioral therapy&#xD;
      for depression among rural adults. The intervention, called Raising Our Spirits Together&#xD;
      (ROST), was developed via a community-based participatory approach and will be delivered in&#xD;
      small groups, facilitated by local pastors. Groups will be held virtually, or in-person at&#xD;
      two churches in rural Michigan. Eighty-four individuals will be recruited from Hillsdale,&#xD;
      Michigan, to test the effect of ROST on depressive symptoms, compared to an Enhanced Control&#xD;
      Condition (ECC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 20, 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in self-report measure of depressive symptoms</measure>
    <time_frame>Outcome will be assessed at baseline, immediately post-treatment, and 12-weeks post-treatment</time_frame>
    <description>Participants will self report depressive symptoms utilizing the Patient Health Questionnaire-9 (PHQ-9; range 0-27 with higher scores indicating worse outcome)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Raising Our Spirits Together Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Control Condition</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Raising Our Spirits Together</intervention_name>
    <description>Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.</description>
    <arm_group_label>Raising Our Spirits Together Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Control Condition</intervention_name>
    <description>The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.</description>
    <arm_group_label>Enhanced Control Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must live in Hillsdale, Lenawee, Jackson, or Calhoun County, Michigan&#xD;
&#xD;
          -  Positive screen for at least mild depressive symptoms based on the the Patient Health&#xD;
             Questionnaire-9 (PHQ-9&gt;=5)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Currently receiving cognitive behavioral therapy (CBT) for depression&#xD;
&#xD;
          -  Ever completed a course of cognitive behavioral therapy (CBT; &gt;=8 sessions)&#xD;
&#xD;
          -  Diagnosis of a psychotic disorder&#xD;
&#xD;
          -  Current use of opiates or freebase cocaine&#xD;
&#xD;
          -  Prominent suicidal/homicidal ideation with imminent risk.&#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>Addie Weaver, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Addie Weaver, PhD</last_name>
    <phone>7346152122</phone>
    <email>weaverad@umich.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Trinity Lutheran Church</name>
      <address>
        <city>Hillsdale</city>
        <state>Michigan</state>
        <zip>49242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Hahn</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jonesville First Presbyterian Church</name>
      <address>
        <city>Jonesville</city>
        <state>Michigan</state>
        <zip>49250</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lynne McQuown</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Addie Weaver</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>Yes</sharing_ipd>
    <ipd_description>IPD will be made available through NIMH Data Archive (NDAR) after the end of the study.</ipd_description>
  </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/NCT04502186
org study id: HUM00176192
secondary id: K01MH110605
nct id: NCT04502186
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to test the effectiveness of a computer-assisted cognitive behavioral therapy
      for depression among rural adults. The intervention, called Raising Our Spirits Together
      (ROST), was developed via a community-based participatory approach and will be delivered in
      small groups, facilitated by local pastors. Groups will be held virtually, or in-person at
      two churches in rural Michigan. Eighty-four individuals will be recruited from Hillsdale,
      Michigan, to test the effect of ROST on depressive symptoms, compared to an Enhanced Control
      Condition (ECC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in self-report measure of depressive symptoms
time frame: Outcome will be assessed at baseline, immediately post-treatment, and 12-weeks post-treatment
description: Participants will self report depressive symptoms utilizing the Patient Health Questionnaire-9 (PHQ-9; range 0-27 with higher scores indicating worse outcome)
arm group label: Raising Our Spirits Together Intervention
arm group type: Experimental
arm group label: Enhanced Control Condition
arm group type: Other
intervention type: Behavioral
intervention name: Raising Our Spirits Together
description: Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.
arm group label: Raising Our Spirits Together Intervention
intervention type: Other
intervention name: Enhanced Control Condition
description: The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.
arm group label: Enhanced Control Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Addie Weaver, PhD
role: Principal Investigator
affiliation: University of Michigan
last name: Addie Weaver, PhD
phone: 7346152122
email: weaverad@umich.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Addie Weaver
investigator title: Assistant Professor
mesh term: Depression
sharing ipd: Yes
ipd description: IPD will be made available through NIMH Data Archive (NDAR) after the end of the study.