<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/NCT03788408</url>
  </required_header>
  <id_info>
    <org_study_id>1001</org_study_id>
    <nct_id>NCT03788408</nct_id>
  </id_info>
  <brief_title>Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care</brief_title>
  <official_title>Effects of Intensive Psychotherapy and Case Management for Karen Refugees in Primary Care: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Center for Victims of Torture, United States</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HealthEast Care System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Center for Victims of Torture, United States</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>
      Patients in the IPCM group (n = 112) received intensive psychotherapy and case management,&#xD;
      and those in the CAU group (n = 102) received care as usual, including behavioral health&#xD;
      referrals and/or brief onsite interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IPCM patients received routine services from both a psychotherapist and separate mental&#xD;
      health case manager for one year; duration of each appointment was 45 minutes - 1 hour;&#xD;
      frequency of appointments was weekly or every other week, dependent on participant&#xD;
      availability. A face-to-face professional interpreter was utilized unless the CVT provider&#xD;
      was a native Karen speaker.&#xD;
&#xD;
      Participants in the control group received care as usual, without CVT involvement other than&#xD;
      administration of the outcome measures. Once randomized, CAU patients could be referred to a&#xD;
      full range of outpatient and community-based behavioral health services by their primary care&#xD;
      physician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 1, 2013</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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 Depression over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Hopkins Symptom Trauma Checklist (HSCL-25) consists of 25 items with 15 items evaluating depression symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Anxiety over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Hopkins Symptom Trauma Checklist (HSCL-25) consists of 25 items with 10 items assessing anxiety symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PTSD over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Posttraumatic Stress Disorder (PDS-5) consists of 21 items evaluating symptoms of posttraumatic stress with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of PTSD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pain over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Pain Complaints Scale consists of 5 items assessing general pain symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Safety/Basic Needs over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Safety/basic needs measures frequency and quality of basic needs met in housing, clothing, food, and transportation. Subscale scores are calculated as total scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Immigration Stability over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Immigration stability measures legal status and stability for work, healthcare and residence in the country and progress towards citizenship. Subscale scores are calculated as total scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Employment over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Employment subscale consists of 5 items measuring motivation for, and frequency and quality of employment. Subscale scores are calculated as total scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Social Support over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). The social support subscale consists of 5 items measuring frequency and quality of social connections in family and friends. Subscale scores are calculated as total scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cultural Adjustment over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (lower functioning) to 4 (higher functioning). Cultural Adjustment consists of 5 items measuring adaptation to new cultural and geographic community.&#xD;
Subscale scores are calculated as total scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Community Engagement over time</measure>
    <time_frame>Collected at baseline, 3, 6, and 12 months</time_frame>
    <description>Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Community engagement consists of 6 items measuring participation in civic, political, social and educational activities in the geographic community. Subscale scores are calculated as total scores.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">214</enrollment>
  <condition>Delivery of Intensive Behavioral Services to Refugees in Primary Care</condition>
  <arm_group>
    <arm_group_label>Intensive Psychotherapy Case Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group received Intensive Psychotherapy and Case Management (IPCM) delivered by psychotherapists and social worker with expertise in refugee trauma and mental health.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as Usual group received ongoing care from their primary care providers without the involvement of CVT (except for the collection of outcomes). TAU patients could be referred to a full range of outpatient and community-based behavioral health services by their primary care physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Psychotherapy and case management for refugee trauma</intervention_name>
    <description>CVT's approach emphasized active interdisciplinary coordination and a relational focus anchored in cultural humilityX to address survivors' priorities, empower survivors as the primary architects of their healing, and work alongside each survivor to co-construct meaning and behavioral change.</description>
    <arm_group_label>Intensive Psychotherapy Case Management</arm_group_label>
    <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligibility criteria included Major Depression diagnosis by SCID interview, Karen&#xD;
             refugee, ages 18-65.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were current participation in individual psychotherapy or case&#xD;
             management, psychosis, or substance use problems on the CAGE-AID.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Center for Victims of Torture, United States</investigator_affiliation>
    <investigator_full_name>Maria Vukovich</investigator_full_name>
    <investigator_title>Research Associate</investigator_title>
  </responsible_party>
  <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/NCT03788408
org study id: 1001
nct id: NCT03788408
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients in the IPCM group (n = 112) received intensive psychotherapy and case management,
      and those in the CAU group (n = 102) received care as usual, including behavioral health
      referrals and/or brief onsite interventions.
IPCM patients received routine services from both a psychotherapist and separate mental
      health case manager for one year; duration of each appointment was 45 minutes - 1 hour;
      frequency of appointments was weekly or every other week, dependent on participant
      availability. A face-to-face professional interpreter was utilized unless the CVT provider
      was a native Karen speaker.

      Participants in the control group received care as usual, without CVT involvement other than
      administration of the outcome measures. Once randomized, CAU patients could be referred to a
      full range of outpatient and community-based behavioral health services by their primary care
      physician.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Depression over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Hopkins Symptom Trauma Checklist (HSCL-25) consists of 25 items with 15 items evaluating depression symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of depression.
measure: Change in Anxiety over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Hopkins Symptom Trauma Checklist (HSCL-25) consists of 25 items with 10 items assessing anxiety symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of anxiety.
measure: Change in PTSD over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Posttraumatic Stress Disorder (PDS-5) consists of 21 items evaluating symptoms of posttraumatic stress with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of PTSD.
measure: Change in Pain over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Pain Complaints Scale consists of 5 items assessing general pain symptoms with response scale scores ranging from 1 (not at all) to 4 (extremely) indicating the frequency and severity of symptoms. Low scores indicate low symptoms while higher scores indicate greater symptoms of pain.
measure: Change in Safety/Basic Needs over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Safety/basic needs measures frequency and quality of basic needs met in housing, clothing, food, and transportation. Subscale scores are calculated as total scores.
measure: Change in Immigration Stability over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Immigration stability measures legal status and stability for work, healthcare and residence in the country and progress towards citizenship. Subscale scores are calculated as total scores.
measure: Change in Employment over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Employment subscale consists of 5 items measuring motivation for, and frequency and quality of employment. Subscale scores are calculated as total scores.
measure: Change in Social Support over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). The social support subscale consists of 5 items measuring frequency and quality of social connections in family and friends. Subscale scores are calculated as total scores.
measure: Change in Cultural Adjustment over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (lower functioning) to 4 (higher functioning). Cultural Adjustment consists of 5 items measuring adaptation to new cultural and geographic community.
Subscale scores are calculated as total scores.
measure: Change in Community Engagement over time
time frame: Collected at baseline, 3, 6, and 12 months
description: Social Circumstances and Social Functioning Inventory (SCFI-37), consists of 37 items that measure adaptive social functioning in 6 subscales (safety/basic needs, immigration stability, employment, social support, cultural adjustment and community engagement) with response scale scores ranging from 0 (low functioning) to 4 (high functioning). Community engagement consists of 6 items measuring participation in civic, political, social and educational activities in the geographic community. Subscale scores are calculated as total scores.
arm group label: Intensive Psychotherapy Case Management
arm group type: Experimental
description: Treatment group received Intensive Psychotherapy and Case Management (IPCM) delivered by psychotherapists and social worker with expertise in refugee trauma and mental health.
arm group label: Treatment as Usual (TAU)
arm group type: Active Comparator
description: Treatment as Usual group received ongoing care from their primary care providers without the involvement of CVT (except for the collection of outcomes). TAU patients could be referred to a full range of outpatient and community-based behavioral health services by their primary care physician.
intervention type: Behavioral
intervention name: Intensive Psychotherapy and case management for refugee trauma
description: CVT's approach emphasized active interdisciplinary coordination and a relational focus anchored in cultural humilityX to address survivors' priorities, empower survivors as the primary architects of their healing, and work alongside each survivor to co-construct meaning and behavioral change.
arm group label: Intensive Psychotherapy Case Management
arm group label: Treatment as Usual (TAU)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: The Center for Victims of Torture, United States
investigator full name: Maria Vukovich
investigator title: Research Associate
sharing ipd: No