<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/NCT02236377</url>
  </required_header>
  <id_info>
    <org_study_id>TU1458R1</org_study_id>
    <nct_id>NCT02236377</nct_id>
  </id_info>
  <brief_title>Dismantling Exposure, Relaxation, and Rescripting Therapy</brief_title>
  <acronym>ERRT</acronym>
  <official_title>Exposure, Relaxation, Rescripting Therapy (ERRT) Dismantling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tulsa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tulsa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this case series dismantling study is to extend previous findings regarding&#xD;
      the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose&#xD;
      effect and mechanism of change.&#xD;
&#xD;
      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological&#xD;
      intervention developed to target trauma-related nightmares and sleep disturbances. ERRT has&#xD;
      exhibited strong support in reducing the frequency and intensity of nightmares, as well as&#xD;
      improving overall sleep quality in both civilian and veteran samples. In addition,&#xD;
      significant decreases in PTSD and depression symptoms have been reported following treatment&#xD;
      (Davis et al., 2011; Davis &amp; Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, &amp;&#xD;
      Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis,&#xD;
      Rhudy, &amp; Favorite, 2011).&#xD;
&#xD;
      Despite this evidence, the mechanism of change for ERRT remains unclear. We propose to&#xD;
      conduct a set of case series in order to examine the possible mechanisms: psycho-education,&#xD;
      dose response for exposure, and no exposure components of the treatment. Each part of the&#xD;
      treatment is theorized to contribute to the improved treatment outcome and it is hypothesized&#xD;
      that participants will benefit no matter what group they are in. All participants will&#xD;
      receive 5 to 6 treatment sessions, conducted once per week for about 90 minutes, of a&#xD;
      modified version of ERRT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nightmare Frequency Past Week</measure>
    <time_frame>up to 6 months followup</time_frame>
    <description>This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Frequent Trauma-related Nightmares</condition>
  <arm_group>
    <arm_group_label>ERRT - Enhanced Exposure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERRT - Sleep and Relaxation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERRT-Rescription</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERRT-Sleep</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERRT - Consensus Manual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consensus Protocol, 6 sessions, includes components of ERRT and other nightmare protocols.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure, Relaxation, and Rescripting Therapy</intervention_name>
    <description>Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems</description>
    <arm_group_label>ERRT - Consensus Manual</arm_group_label>
    <arm_group_label>ERRT - Enhanced Exposure</arm_group_label>
    <arm_group_label>ERRT - Sleep and Relaxation</arm_group_label>
    <arm_group_label>ERRT-Rescription</arm_group_label>
    <arm_group_label>ERRT-Sleep</arm_group_label>
    <other_name>ERRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older at the time of the intake,&#xD;
&#xD;
          -  experienced a traumatic event, as defined by the Diagnostic and Statistical Manual&#xD;
             (DSM-5),&#xD;
&#xD;
          -  have approximately one nightmare each week for the past month&#xD;
&#xD;
          -  be able to read and speak English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age of 17 or younger&#xD;
&#xD;
          -  acute or apparent psychosis&#xD;
&#xD;
          -  unmedicated bipolar disorder&#xD;
&#xD;
          -  intellectual disability&#xD;
&#xD;
          -  active suicidality,&#xD;
&#xD;
          -  recent parasuicidal behaviors&#xD;
&#xD;
          -  untreated substance use disorder in past 6 months&#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>Joanne L Davis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tulsa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joanne L Davis, PhD</last_name>
    <phone>9186312875</phone>
    <email>joanne-davis@utulsa.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lucia D Villarreal, MS</last_name>
    <phone>9186313976</phone>
    <email>LDV0460@utulsa.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Joanne L. Davis</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanne L Davis, PhD</last_name>
      <phone>918-631-2875</phone>
      <email>joanne-davis@utulsa.edu</email>
    </contact>
    <contact_backup>
      <last_name>Lucia D Villarreal, MS</last_name>
      <phone>9186313976</phone>
      <email>LDV0460@utulsa.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Joanne L Davis, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Davis JL, Rhudy JL, Pruiksma KE, Byrd P, Williams AE, McCabe KM, Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med. 2011 Dec 15;7(6):622-31. doi: 10.5664/jcsm.1466.</citation>
    <PMID>22171201</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Tulsa</investigator_affiliation>
    <investigator_full_name>Joanne Davis</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>ERRT</keyword>
  <keyword>Nightmares</keyword>
  <keyword>Sleep</keyword>
  <keyword>Trauma</keyword>
  <keyword>PTSD</keyword>
  <!-- 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/NCT02236377
org study id: TU1458R1
nct id: NCT02236377
lead sponsor: 
has dmc: No
The purpose of this case series dismantling study is to extend previous findings regarding
      the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose
      effect and mechanism of change.

      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological
      intervention developed to target trauma-related nightmares and sleep disturbances. ERRT has
      exhibited strong support in reducing the frequency and intensity of nightmares, as well as
      improving overall sleep quality in both civilian and veteran samples. In addition,
      significant decreases in PTSD and depression symptoms have been reported following treatment
      (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, &
      Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis,
      Rhudy, & Favorite, 2011).

      Despite this evidence, the mechanism of change for ERRT remains unclear. We propose to
      conduct a set of case series in order to examine the possible mechanisms: psycho-education,
      dose response for exposure, and no exposure components of the treatment. Each part of the
      treatment is theorized to contribute to the improved treatment outcome and it is hypothesized
      that participants will benefit no matter what group they are in. All participants will
      receive 5 to 6 treatment sessions, conducted once per week for about 90 minutes, of a
      modified version of ERRT.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Nightmare Frequency Past Week
time frame: up to 6 months followup
description: This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).
arm group label: ERRT - Enhanced Exposure
arm group type: Active Comparator
description: Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques
arm group label: ERRT - Sleep and Relaxation
arm group type: Active Comparator
description: Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation
arm group label: ERRT-Rescription
arm group type: Active Comparator
description: Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure
arm group label: ERRT-Sleep
arm group type: Active Comparator
description: Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques
arm group label: ERRT - Consensus Manual
arm group type: Active Comparator
description: Consensus Protocol, 6 sessions, includes components of ERRT and other nightmare protocols.
intervention type: Behavioral
intervention name: Exposure, Relaxation, and Rescripting Therapy
description: Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
arm group label: ERRT - Consensus Manual
arm group label: ERRT - Enhanced Exposure
arm group label: ERRT - Sleep and Relaxation
arm group label: ERRT-Rescription
arm group label: ERRT-Sleep
other name: ERRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanne L Davis, PhD
role: Principal Investigator
affiliation: University of Tulsa
last name: Joanne L Davis, PhD
phone: 9186312875
email: joanne-davis@utulsa.edu
last name: Lucia D Villarreal, MS
phone: 9186313976
email: LDV0460@utulsa.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: Davis JL, Rhudy JL, Pruiksma KE, Byrd P, Williams AE, McCabe KM, Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med. 2011 Dec 15;7(6):622-31. doi: 10.5664/jcsm.1466.
PMID: 22171201
responsible party type: Principal Investigator
investigator affiliation: University of Tulsa
investigator full name: Joanne Davis
investigator title: Associate Professor