<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/NCT03761732</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00005522</org_study_id>
    <nct_id>NCT03761732</nct_id>
  </id_info>
  <brief_title>Islamic Trauma Healing: Feasibility Study</brief_title>
  <official_title>Islamic Trauma Healing: Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seattle Pacific University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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 will examine the initial feasibility of a program called Islamic Trauma Healing by&#xD;
      conducting a small feasibility study (N = 20) of Islamic Trauma Healing in Somalia on key&#xD;
      targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that&#xD;
      those in Islamic Trauma Healing will show a reduction of PTSD symptoms, depressive symptoms,&#xD;
      and somatic symptoms and show improvement in quality of well-being. Feasibility will also be&#xD;
      examined by examining at retention, satisfaction, and community feedback.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Islamic Trauma Healing is a lay-led, small-group intervention specifically targeting healing&#xD;
      mental wounds of trauma within mosques. The six-session intervention combines empirically&#xD;
      supported exposure-based and cognitive restructuring techniques with Islamic principles. A&#xD;
      lay-led, group program promotes community building, acknowledges trauma's impact in the&#xD;
      community, and facilitates wider implementation. The program is not referred to as &quot;therapy&quot;&#xD;
      or &quot;treatment&quot; for &quot;mental illness.&quot; It incorporates community building (e.g., shared tea,&#xD;
      supplication), integrated Islamic principles that utilize cognitive restructuring through&#xD;
      discussion of prophet narratives (e.g., faith during hard times, Prophet Job [Ayyub]), and&#xD;
      exposure therapy through individual prayer, talking to Allah about the trauma. Ultimately,&#xD;
      the program will follow a self-sustaining train-the-trainer model, led by group leaders,&#xD;
      empowering lay leaders to facilitate healing in their communities. Further, training time is&#xD;
      dramatically reduced to two, 4-hour training sessions, focusing on teaching skills of group&#xD;
      discussion leading rather than training as a lay therapist or mental health counselor.&#xD;
      Preliminary data from a community sample and from initial men's and women's groups show a&#xD;
      strong perceived need and match with the Islamic faith, with large effects obtained for pre-&#xD;
      to post-group across measures (g = 0.76-3.22). Qualitative analysis identified the&#xD;
      intervention as operating on potential mechanisms of connectedness to the community, faith&#xD;
      integration, healing, and growth. The preliminary data point to the program being&#xD;
      well-received and offering a promising model for delivery of a trauma-focused intervention to&#xD;
      Muslim communities. The next steps are examining Islamic Trauma Healing in low and&#xD;
      moderate-income Muslim countries, examining the feasibility of implementing this lay-led&#xD;
      program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Actual">February 6, 2019</completion_date>
  <primary_completion_date type="Actual">February 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is an active intervention feasibility study, using a pre-post clinical trial design; there is no randomization and no control intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015</measure>
    <time_frame>Last 1 Week</time_frame>
    <description>PTSD symptoms will be measured using the PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015). Twenty items comprise the PTSD severity scale, with scores ranging from 0 to 80 and higher scores indicating higher PTSD severity. A total score is calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, &amp; Williams, 2001)</measure>
    <time_frame>Last 1 Week</time_frame>
    <description>The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, &amp; Williams, 2002)</measure>
    <time_frame>Last 1 Week</time_frame>
    <description>The PHQ-15 is a self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of well-being Index</measure>
    <time_frame>Last 1 Week</time_frame>
    <description>The WHO-5 Wellbeing Index (WHO-5; Bech, Olsen, Kjoller, &amp; Rasmussen, 2003) will be used to measure well-being. This five-item measure assesses emotional well-being on a 0-5 scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>PTSD lay-led group treatment program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group will go through the Islamic Trauma Healing Program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Islamic Trauma Healing</intervention_name>
    <description>6 session behavioral intervention program designed to reduce PTSD and related symptomatology</description>
    <arm_group_label>PTSD lay-led group treatment program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Experienced a DSM-5 trauma at least 12 weeks ago&#xD;
&#xD;
          -  Report current re-experiencing or avoidance symptoms&#xD;
&#xD;
          -  Islamic faith&#xD;
&#xD;
          -  18-65 year of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immediate suicide risk, with intent or plan&#xD;
&#xD;
          -  Cannot understand consent/visible cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Zoellner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Borama Mosque</name>
      <address>
        <city>Borama</city>
        <country>Somalia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hargeisa Mosque</name>
      <address>
        <city>Hargeisa</city>
        <country>Somalia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Somalia</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Lori Zoellner</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03761732/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>July 16, 2021</submitted>
    <returned>August 6, 2021</returned>
    <submitted>February 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03761732
org study id: STUDY00005522
nct id: NCT03761732
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will examine the initial feasibility of a program called Islamic Trauma Healing by
      conducting a small feasibility study (N = 20) of Islamic Trauma Healing in Somalia on key
      targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that
      those in Islamic Trauma Healing will show a reduction of PTSD symptoms, depressive symptoms,
      and somatic symptoms and show improvement in quality of well-being. Feasibility will also be
      examined by examining at retention, satisfaction, and community feedback.
Islamic Trauma Healing is a lay-led, small-group intervention specifically targeting healing
      mental wounds of trauma within mosques. The six-session intervention combines empirically
      supported exposure-based and cognitive restructuring techniques with Islamic principles. A
      lay-led, group program promotes community building, acknowledges trauma's impact in the
      community, and facilitates wider implementation. The program is not referred to as "therapy"
      or "treatment" for "mental illness." It incorporates community building (e.g., shared tea,
      supplication), integrated Islamic principles that utilize cognitive restructuring through
      discussion of prophet narratives (e.g., faith during hard times, Prophet Job [Ayyub]), and
      exposure therapy through individual prayer, talking to Allah about the trauma. Ultimately,
      the program will follow a self-sustaining train-the-trainer model, led by group leaders,
      empowering lay leaders to facilitate healing in their communities. Further, training time is
      dramatically reduced to two, 4-hour training sessions, focusing on teaching skills of group
      discussion leading rather than training as a lay therapist or mental health counselor.
      Preliminary data from a community sample and from initial men's and women's groups show a
      strong perceived need and match with the Islamic faith, with large effects obtained for pre-
      to post-group across measures (g = 0.76-3.22). Qualitative analysis identified the
      intervention as operating on potential mechanisms of connectedness to the community, faith
      integration, healing, and growth. The preliminary data point to the program being
      well-received and offering a promising model for delivery of a trauma-focused intervention to
      Muslim communities. The next steps are examining Islamic Trauma Healing in low and
      moderate-income Muslim countries, examining the feasibility of implementing this lay-led
      program.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is an active intervention feasibility study, using a pre-post clinical trial design; there is no randomization and no control intervention.
primary purpose: Treatment
masking: None (Open Label)
measure: PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015
time frame: Last 1 Week
description: PTSD symptoms will be measured using the PTSD Scale - Self-Report for DSM-5 (PS-SR-5; Foa et al., 2015). Twenty items comprise the PTSD severity scale, with scores ranging from 0 to 80 and higher scores indicating higher PTSD severity. A total score is calculated.
measure: Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
time frame: Last 1 Week
description: The PHQ-9 is a self-report measure of depression symptoms with each question rated from 0-3.
measure: Somatic symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15; Kroenke, Spitzer, & Williams, 2002)
time frame: Last 1 Week
description: The PHQ-15 is a self-report assessment of somatic symptoms (e.g., stomach pain, headaches, dizziness) .
measure: Quality of well-being Index
time frame: Last 1 Week
description: The WHO-5 Wellbeing Index (WHO-5; Bech, Olsen, Kjoller, & Rasmussen, 2003) will be used to measure well-being. This five-item measure assesses emotional well-being on a 0-5 scale
arm group label: PTSD lay-led group treatment program
arm group type: Experimental
description: The group will go through the Islamic Trauma Healing Program
intervention type: Behavioral
intervention name: Islamic Trauma Healing
description: 6 session behavioral intervention program designed to reduce PTSD and related symptomatology
arm group label: PTSD lay-led group treatment program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lori Zoellner, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
facility: 
country: Somalia
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Lori Zoellner
investigator title: Professor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
provided document: 
submitted: July 16, 2021
returned: August 6, 2021
submitted: February 20, 2023