<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/NCT04418778</url>
  </required_header>
  <id_info>
    <org_study_id>54562</org_study_id>
    <nct_id>NCT04418778</nct_id>
  </id_info>
  <brief_title>The BEAR Therapeutic Program for Women</brief_title>
  <official_title>The Building Empowerment and Resilience Therapeutic Program for Women With a History of Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      The current study aims to test a novel therapeutic intervention for women who have a history&#xD;
      of interpersonal trauma. The Building Empowerment and Resilience (BEAR) Therapeutic group&#xD;
      incorporates psychological skills, psychoeducation, and physical empowerment training, all&#xD;
      within a therapeutic process. It will be implemented at several different sites, with women&#xD;
      who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect). We&#xD;
      aim to understand how this program effects one's self-efficacy and whether the program can&#xD;
      reduce rates mental health problems (such as depression and anxiety) and reduce the rates of&#xD;
      revictimization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2023</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Coping Self-Efficacy Scale (CSES)</measure>
    <time_frame>baseline to post-group (3 months)</time_frame>
    <description>The CSES is designed to measure an individual's perception of her competence to carry out coping strategies effectively when faced with a challenge or threat.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trauma Symptom Inventory-II (TSI-2).</measure>
    <time_frame>baseline to post-group (3 months)</time_frame>
    <description>The TSI-2 is a self-report measure of trauma-related symptoms and behaviors.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Trauma, Psychological</condition>
  <condition>Depression, Anxiety</condition>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>BEAR intervention group</arm_group_label>
    <description>BEAR Therapeutic group for women who have experienced interpersonal trauma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Condition</arm_group_label>
    <description>Treatment as usual group, women participating in individual or group therapy but not taking the BEAR group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BEAR</intervention_name>
    <description>Building Empowerment and Resilience Therapy group</description>
    <arm_group_label>BEAR intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who have experienced interpersonal violence broadly defined&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women ages 18-70&#xD;
&#xD;
          2. History of physical, sexual, and/or emotional abuse/neglect/violence, with subsequent&#xD;
             interpersonal or psychological distress (e.g., depression or anxiety) related to this&#xD;
             history.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active, significant substance abuse&#xD;
&#xD;
          2. Significant medical conditions that would preclude safe participation in the study&#xD;
&#xD;
          3. High levels of depression with significant suicide risk&#xD;
&#xD;
          4. Psychiatric instability&#xD;
&#xD;
          5. History of assaultive behavior or is judged to be at potential risk to assault others.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female identified participants</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jennifer Keller, PhD</last_name>
    <phone>650-723-8330</phone>
    <email>BEARstudy@stanford.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Keller, PHD</last_name>
      <phone>650-723-8330</phone>
      <email>jkeller@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>Maureen Chang, B.S.</last_name>
      <phone>(650) 723-8330</phone>
      <email>maureen.chang@stanford.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jennifer Keller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Jennifer Keller</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>empowerment</keyword>
  <keyword>therapeutic intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychological Trauma</mesh_term>
  </condition_browse>
  <!-- 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/NCT04418778
org study id: 54562
nct id: NCT04418778
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study aims to test a novel therapeutic intervention for women who have a history
      of interpersonal trauma. The Building Empowerment and Resilience (BEAR) Therapeutic group
      incorporates psychological skills, psychoeducation, and physical empowerment training, all
      within a therapeutic process. It will be implemented at several different sites, with women
      who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect). We
      aim to understand how this program effects one's self-efficacy and whether the program can
      reduce rates mental health problems (such as depression and anxiety) and reduce the rates of
      revictimization.
observational model: Cohort
time perspective: Prospective
measure: Change in Coping Self-Efficacy Scale (CSES)
time frame: baseline to post-group (3 months)
description: The CSES is designed to measure an individual's perception of her competence to carry out coping strategies effectively when faced with a challenge or threat.
measure: Trauma Symptom Inventory-II (TSI-2).
time frame: baseline to post-group (3 months)
description: The TSI-2 is a self-report measure of trauma-related symptoms and behaviors.
arm group label: BEAR intervention group
description: BEAR Therapeutic group for women who have experienced interpersonal trauma
arm group label: Control Condition
description: Treatment as usual group, women participating in individual or group therapy but not taking the BEAR group
intervention type: Behavioral
intervention name: BEAR
description: Building Empowerment and Resilience Therapy group
arm group label: BEAR intervention group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: female identified participants
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jennifer Keller, PhD
phone: 650-723-8330
email: BEARstudy@stanford.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Jennifer Keller
investigator title: Clinical Professor
mesh term: Psychological Trauma