<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/NCT02236390</url>
  </required_header>
  <id_info>
    <org_study_id>TU1459R1</org_study_id>
    <secondary_id>HR14-127</secondary_id>
    <nct_id>NCT02236390</nct_id>
  </id_info>
  <brief_title>Integrating Sleep, Nightmare and PTSD Treatments</brief_title>
  <acronym>CPTERRT</acronym>
  <official_title>Integrating Sleep and PTSD Treatment: Examining the Role of Emotion Regulation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the proposed pilot study is to extend previous findings regarding the efficacy&#xD;
      of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this&#xD;
      treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive&#xD;
      processing therapy (CPT) (Resick &amp; Schnicke, 1996) is a well-established and efficacious&#xD;
      evidence-based psychological treatment for PTSD in both civilian and veteran populations&#xD;
      (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver,&#xD;
      Astin, &amp; Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the&#xD;
      first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without&#xD;
      the utilization of written exposure (CPT-C) may be more effective than the original protocol.&#xD;
      However, despite such promising evidence, individuals who experience chronic nightmares and&#xD;
      sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment&#xD;
      (Nappi, Drummond, &amp; Hall, 2012). Given that nightmares are considered the hallmark of PTSD&#xD;
      (Ross, Ball, Sullivan, &amp; Caroff, 1989) and their treatment-resistant nature (Davis &amp; Wright,&#xD;
      2007), specific psychological treatments have been developed to target sleep disturbances and&#xD;
      nightmares.&#xD;
&#xD;
      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological&#xD;
      intervention developed to target trauma-related nightmares and sleep disturbances. Though&#xD;
      further evidence is needed, ERRT has exhibited strong support in reducing the frequency and&#xD;
      intensity of nightmares, as well as improving overall sleep quality in both civilian and&#xD;
      veteran samples. In addition, significant decreases in PTSD and depression symptoms have been&#xD;
      reported following treatment (Davis et al., 2011; Davis &amp; Wright, 2007; Long et al., 2011;&#xD;
      Swanson, Favorite, Horin, &amp; Arnedt, 2009). ERRT is currently an evidence-level B suggested&#xD;
      treatment (Cranston, Davis, Rhudy, &amp; Favorite, 2011).&#xD;
&#xD;
      There is a call to research suggesting the importance of treatment studies which focus on&#xD;
      interventions that integrate nightmare and sleep symptom treatment with evidence-based&#xD;
      treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to&#xD;
      tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to&#xD;
      CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's&#xD;
      treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances.&#xD;
      Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively&#xD;
      (Bonn-Miller, Babson, Vujanovic, &amp; Feldner, 2010; Hofstetter, Lysaker, &amp; Mayeda, 2005;&#xD;
      Nishith, Resick, &amp; Mueser, 2001). Thus, with improved sleep an individual may have additional&#xD;
      personal coping resources for which s/he can use to address the broader trauma issues (Nappi&#xD;
      et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT&#xD;
      alone.&#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">August 2025</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>Nightmare Frequency</measure>
    <time_frame>up to 6-months follow-up</time_frame>
    <description>A fill-in-the blank question (range = 0-X nightmares) from the Trauma Related Nightmare Survey will be utilized to determine the past week nightmare frequency at baseline, and 3 and 6 months follow-up. Higher values indicate more nightmares.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinician Administered PTSD Scale</measure>
    <time_frame>Past Month symptoms measured at baseline, and 3 and 6 month follow-up</time_frame>
    <description>This semi-structured clinical interview assesses severity of each of 30 items measuring Diagnostic and Statistical Manual (DSM-5) criteria for PTSD on a 5-point scale (0 - 4), (possible range: 0-80). A symptom is considered present if the severity is rated 2 or higher. Total scores are comprised of four factors (reexperiencing, avoidance, cognitive/emotional and hyperarousal)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Nightmares</condition>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Cognitive Processing Therapy-Cognitive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 sessions of cognitive processing therapy-Cognitive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERRT + CPT-C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPT-C + ERRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure, Relaxation, and Rescripting Therapy</intervention_name>
    <description>5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms</description>
    <arm_group_label>CPT-C + ERRT</arm_group_label>
    <arm_group_label>ERRT + CPT-C</arm_group_label>
    <other_name>ERRT</other_name>
    <other_name>IRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Processing Therapy - Cognitive</intervention_name>
    <description>12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.</description>
    <arm_group_label>CPT-C + ERRT</arm_group_label>
    <arm_group_label>Cognitive Processing Therapy-Cognitive</arm_group_label>
    <arm_group_label>ERRT + CPT-C</arm_group_label>
    <other_name>CPT-C</other_name>
    <other_name>CPT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 Years of Age minimal&#xD;
&#xD;
          -  Experienced a trauma&#xD;
&#xD;
          -  One nightmare per week for past month, minimal&#xD;
&#xD;
          -  meet full criteria for PTSD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  17 years of age or younger&#xD;
&#xD;
          -  acute psychosis&#xD;
&#xD;
          -  bipolar disorder&#xD;
&#xD;
          -  intellectual disability&#xD;
&#xD;
          -  active suicidality&#xD;
&#xD;
          -  untreated substance use disorder within 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>University of Tulsa</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>
  <link>
    <url>http://nightmaretreatment.org</url>
    <description>Related Info</description>
  </link>
  <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 22, 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>Professor</investigator_title>
  </responsible_party>
  <keyword>Nightmare</keyword>
  <keyword>PTSD</keyword>
  <keyword>Sleep</keyword>
  <keyword>Emotion Regulation</keyword>
  <keyword>Exposure Relaxation and Rescripting Therapy</keyword>
  <keyword>Cognitive Processing Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT02236390
org study id: TU1459R1
secondary id: HR14-127
nct id: NCT02236390
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the proposed pilot study is to extend previous findings regarding the efficacy
      of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this
      treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive
      processing therapy (CPT) (Resick & Schnicke, 1996) is a well-established and efficacious
      evidence-based psychological treatment for PTSD in both civilian and veteran populations
      (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver,
      Astin, & Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the
      first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without
      the utilization of written exposure (CPT-C) may be more effective than the original protocol.
      However, despite such promising evidence, individuals who experience chronic nightmares and
      sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment
      (Nappi, Drummond, & Hall, 2012). Given that nightmares are considered the hallmark of PTSD
      (Ross, Ball, Sullivan, & Caroff, 1989) and their treatment-resistant nature (Davis & Wright,
      2007), specific psychological treatments have been developed to target sleep disturbances and
      nightmares.

      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological
      intervention developed to target trauma-related nightmares and sleep disturbances. Though
      further evidence is needed, 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).

      There is a call to research suggesting the importance of treatment studies which focus on
      interventions that integrate nightmare and sleep symptom treatment with evidence-based
      treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to
      tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to
      CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's
      treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances.
      Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively
      (Bonn-Miller, Babson, Vujanovic, & Feldner, 2010; Hofstetter, Lysaker, & Mayeda, 2005;
      Nishith, Resick, & Mueser, 2001). Thus, with improved sleep an individual may have additional
      personal coping resources for which s/he can use to address the broader trauma issues (Nappi
      et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT
      alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Nightmare Frequency
time frame: up to 6-months follow-up
description: A fill-in-the blank question (range = 0-X nightmares) from the Trauma Related Nightmare Survey will be utilized to determine the past week nightmare frequency at baseline, and 3 and 6 months follow-up. Higher values indicate more nightmares.
measure: Clinician Administered PTSD Scale
time frame: Past Month symptoms measured at baseline, and 3 and 6 month follow-up
description: This semi-structured clinical interview assesses severity of each of 30 items measuring Diagnostic and Statistical Manual (DSM-5) criteria for PTSD on a 5-point scale (0 - 4), (possible range: 0-80). A symptom is considered present if the severity is rated 2 or higher. Total scores are comprised of four factors (reexperiencing, avoidance, cognitive/emotional and hyperarousal)
arm group label: Cognitive Processing Therapy-Cognitive
arm group type: Active Comparator
description: 12 sessions of cognitive processing therapy-Cognitive
arm group label: ERRT + CPT-C
arm group type: Active Comparator
description: 5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive
arm group label: CPT-C + ERRT
arm group type: Active Comparator
description: 12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy
intervention type: Behavioral
intervention name: Exposure, Relaxation, and Rescripting Therapy
description: 5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms
arm group label: CPT-C + ERRT
arm group label: ERRT + CPT-C
other name: ERRT
other name: IRT
intervention type: Behavioral
intervention name: Cognitive Processing Therapy - Cognitive
description: 12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.
arm group label: CPT-C + ERRT
arm group label: Cognitive Processing Therapy-Cognitive
arm group label: ERRT + CPT-C
other name: CPT-C
other name: CPT
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
url: http://nightmaretreatment.org
description: Related Info
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: Professor
mesh term: Stress Disorders, Post-Traumatic