<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/NCT03229525</url>
  </required_header>
  <id_info>
    <org_study_id>2016-06-0063</org_study_id>
    <nct_id>NCT03229525</nct_id>
  </id_info>
  <brief_title>Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder</brief_title>
  <official_title>Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</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>
      Post-traumatic Stress Disorder (PTSD) is a debilitating mental disorder that affects&#xD;
      approximately 7% of the general population. This project's aim is to develop a greater&#xD;
      understanding of the efficacy and underlying mechanisms of narrative exposure based&#xD;
      treatments for PTSD. Adult participants (N=162) who meet DSM-5 criteria for PTSD will be&#xD;
      enrolled in a 3-arm randomized clinical trial consisting of trauma-related expressive&#xD;
      writing, trauma-related expressive speaking, or a factual expressive writing control&#xD;
      condition. Treatments will be manualized and conducted entirely through the Qualtrics survey&#xD;
      platform. Treatment will consist of six sessions, three per week over two weeks, taking place&#xD;
      via the internet. Assessments will be conducted pre-treatment, post-treatment, and at 1-month&#xD;
      follow-up in the lab. Assessments will be comprised of symptom self-report measures as well&#xD;
      as two tasks completed in an eye tracker: a reading task to evaluate mechanisms underlying&#xD;
      trauma narrative processing and a sentence production task to evaluate attentional shifts&#xD;
      when producing verbal information&#xD;
&#xD;
      Specific Aims and Hypotheses:&#xD;
&#xD;
        1. Develop and test the relative efficacy of two cost-effective internet-based expressive&#xD;
           trauma therapies (written vs. spoken) relative to a non-trauma writing control for PTSD.&#xD;
           We hypothesize that both trauma-focused expressive therapies will achieve more favorable&#xD;
           outcomes at posttreatment and follow-up on measures of PTSD and depression symptoms,&#xD;
           posttraumatic growth, and quality of life compared to the writing control.&#xD;
&#xD;
        2. Conduct exploratory analyses testing baseline PTSD severity, depression severity, trauma&#xD;
           type, time since trauma, and emotional engagement in moderating the differential effects&#xD;
           of the selected expressive therapies.&#xD;
&#xD;
        3. Test the moderation of (1) active language processing with eye tracking (i.e. how long&#xD;
           certain words are fixated on). (2) selected linguistic elements (i.e., frequency of&#xD;
           emotional words, frequency of the pronoun &quot;I&quot;), (3) perceived self-efficacy to cope with&#xD;
           trauma memories; (4) perceived threat appraisals associated with intrusive trauma&#xD;
           memories on treatment outcome at follow-up. We hypothesize that (1) fewer and shorter&#xD;
           fixations on ideographic (i.e. personally relevant) trauma words when reading the trauma&#xD;
           narrative in the eye tracker will be associated with reductions in PTSD symptoms at&#xD;
           follow-up. (2) increased use of emotional words over the course of writing sessions will&#xD;
           be associated with reductions in PTSD and depression symptoms at follow-up; (3) pre- to&#xD;
           posttreatment increases in trauma memory acceptance self-efficacy; and (4) pre- to&#xD;
           posttreatment reductions in trauma memory threat appraisals will be associated with&#xD;
           greater symptom reduction at the follow-up assessment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in PTSD symptom severity</measure>
    <time_frame>Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month, 3 months, 6 months)</time_frame>
    <description>PTSD Symptom Checklist at each assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Depression symptoms</measure>
    <time_frame>Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)</time_frame>
    <description>Becks Depression Inventory at each assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Posttraumatic Growth</measure>
    <time_frame>Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)</time_frame>
    <description>Post Traumatic Growth Inventory at each assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Reading Task indices</measure>
    <time_frame>Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)</time_frame>
    <description>Reading narratives in an eye tracker at each assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sentence Production Task indices</measure>
    <time_frame>Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)</time_frame>
    <description>Describing images in an eye tracker at each assessment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">162</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Trauma Related Expressive Writing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this condition will complete six sessions during which they will write about their trauma for 20 minutes. The participant will receive instructions to write about the traumatic event that they feel affects them the most. For each session they will be instructed to write about the same event. For the first session, participants will complete psychoeducation and treatment rationale modules. The instructions for writing about the traumatic event will emphasize the importance of exploring their deepest emotions and thoughts at the time of the event, as well as providing detailed information about the event itself. For the remaining five writing sessions participants will be instructed to write about the same event and to focus on providing a detailed description of the part of the event that was most distressing to them, as well as how the event had affected their lives. A researcher will review the writing independently to ensure treatment compliance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neutral Expressive Writing</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants randomized to this condition will complete six sessions during which they will write about their day, without describing emotions or opinions. Previous research has shown a significant reduction of symptoms with this type of control writing condition in participants with PTSD (Sloan et al., 2011). A researcher will review the writing to ensure compliance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trauma Related Expressive Writing</intervention_name>
    <description>Participants will write about the traumatic event over the course of six sessions.</description>
    <arm_group_label>Trauma Related Expressive Writing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neutral Expressive Writing</intervention_name>
    <description>Participants will write about a neutral event over the course of six sessions.</description>
    <arm_group_label>Neutral Expressive Writing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females between the ages of 18 and 65&#xD;
&#xD;
          2. Meets Diagnostic and Statistical Manual 5 criteria for PTSD&#xD;
&#xD;
          3. Able to give consent&#xD;
&#xD;
          4. Access to a computer in a private place&#xD;
&#xD;
          5. Completes initial writing samples online&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Impaired vision&#xD;
&#xD;
          2. Bipolar Disorder&#xD;
&#xD;
          3. Psychosis&#xD;
&#xD;
          4. Suicidality&#xD;
&#xD;
          5. Current trauma related treatment&#xD;
&#xD;
          6. Psychotropic medication &lt;2 months or not stable (dosage variable) in past 2 months&#xD;
&#xD;
          7. Reading grade level &gt; 6th grade level&#xD;
&#xD;
          8. Obsessive Compulsive Disorder&#xD;
&#xD;
          9. Traumatic Brain Injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Telch, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas at Austin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mikael Rubin, MA</last_name>
    <role>Study Director</role>
    <affiliation>University of Texas at Austin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Telch, PhD</last_name>
    <phone>(512)-560-4100</phone>
    <email>telch@austin.utexas.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mikael Rubin, MA</last_name>
    <phone>6466854681</phone>
    <email>mikaelrubin@utexas.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Laboratory for the Study of Anxiety Disorders</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mikael Rubin, MA</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://utanxiety.com</url>
    <description>Description Website for the Laboratory for the Study of Anxiety Disorders</description>
  </link>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Michael J. Telch</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>
  <!-- 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/NCT03229525
org study id: 2016-06-0063
nct id: NCT03229525
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-traumatic Stress Disorder (PTSD) is a debilitating mental disorder that affects
      approximately 7% of the general population. This project's aim is to develop a greater
      understanding of the efficacy and underlying mechanisms of narrative exposure based
      treatments for PTSD. Adult participants (N=162) who meet DSM-5 criteria for PTSD will be
      enrolled in a 3-arm randomized clinical trial consisting of trauma-related expressive
      writing, trauma-related expressive speaking, or a factual expressive writing control
      condition. Treatments will be manualized and conducted entirely through the Qualtrics survey
      platform. Treatment will consist of six sessions, three per week over two weeks, taking place
      via the internet. Assessments will be conducted pre-treatment, post-treatment, and at 1-month
      follow-up in the lab. Assessments will be comprised of symptom self-report measures as well
      as two tasks completed in an eye tracker: a reading task to evaluate mechanisms underlying
      trauma narrative processing and a sentence production task to evaluate attentional shifts
      when producing verbal information

      Specific Aims and Hypotheses:

        1. Develop and test the relative efficacy of two cost-effective internet-based expressive
           trauma therapies (written vs. spoken) relative to a non-trauma writing control for PTSD.
           We hypothesize that both trauma-focused expressive therapies will achieve more favorable
           outcomes at posttreatment and follow-up on measures of PTSD and depression symptoms,
           posttraumatic growth, and quality of life compared to the writing control.

        2. Conduct exploratory analyses testing baseline PTSD severity, depression severity, trauma
           type, time since trauma, and emotional engagement in moderating the differential effects
           of the selected expressive therapies.

        3. Test the moderation of (1) active language processing with eye tracking (i.e. how long
           certain words are fixated on). (2) selected linguistic elements (i.e., frequency of
           emotional words, frequency of the pronoun "I"), (3) perceived self-efficacy to cope with
           trauma memories; (4) perceived threat appraisals associated with intrusive trauma
           memories on treatment outcome at follow-up. We hypothesize that (1) fewer and shorter
           fixations on ideographic (i.e. personally relevant) trauma words when reading the trauma
           narrative in the eye tracker will be associated with reductions in PTSD symptoms at
           follow-up. (2) increased use of emotional words over the course of writing sessions will
           be associated with reductions in PTSD and depression symptoms at follow-up; (3) pre- to
           posttreatment increases in trauma memory acceptance self-efficacy; and (4) pre- to
           posttreatment reductions in trauma memory threat appraisals will be associated with
           greater symptom reduction at the follow-up assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in PTSD symptom severity
time frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month, 3 months, 6 months)
description: PTSD Symptom Checklist at each assessment
measure: Change in Depression symptoms
time frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
description: Becks Depression Inventory at each assessment
measure: Change in Posttraumatic Growth
time frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
description: Post Traumatic Growth Inventory at each assessment
measure: Change in Reading Task indices
time frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
description: Reading narratives in an eye tracker at each assessment
measure: Change in Sentence Production Task indices
time frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
description: Describing images in an eye tracker at each assessment
arm group label: Trauma Related Expressive Writing
arm group type: Active Comparator
description: Participants randomized to this condition will complete six sessions during which they will write about their trauma for 20 minutes. The participant will receive instructions to write about the traumatic event that they feel affects them the most. For each session they will be instructed to write about the same event. For the first session, participants will complete psychoeducation and treatment rationale modules. The instructions for writing about the traumatic event will emphasize the importance of exploring their deepest emotions and thoughts at the time of the event, as well as providing detailed information about the event itself. For the remaining five writing sessions participants will be instructed to write about the same event and to focus on providing a detailed description of the part of the event that was most distressing to them, as well as how the event had affected their lives. A researcher will review the writing independently to ensure treatment compliance.
arm group label: Neutral Expressive Writing
arm group type: Sham Comparator
description: Participants randomized to this condition will complete six sessions during which they will write about their day, without describing emotions or opinions. Previous research has shown a significant reduction of symptoms with this type of control writing condition in participants with PTSD (Sloan et al., 2011). A researcher will review the writing to ensure compliance.
intervention type: Behavioral
intervention name: Trauma Related Expressive Writing
description: Participants will write about the traumatic event over the course of six sessions.
arm group label: Trauma Related Expressive Writing
intervention type: Behavioral
intervention name: Neutral Expressive Writing
description: Participants will write about a neutral event over the course of six sessions.
arm group label: Neutral Expressive Writing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michael Telch, Phd
role: Principal Investigator
affiliation: University of Texas at Austin
last name: Mikael Rubin, MA
role: Study Director
affiliation: University of Texas at Austin
last name: Michael Telch, PhD
phone: (512)-560-4100
email: telch@austin.utexas.edu
last name: Mikael Rubin, MA
phone: 6466854681
email: mikaelrubin@utexas.edu
facility: 
status: Recruiting
contact: 
country: United States
url: http://utanxiety.com
description: Description Website for the Laboratory for the Study of Anxiety Disorders
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Michael J. Telch
investigator title: Professor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No