<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/NCT02242110</url>
  </required_header>
  <id_info>
    <org_study_id>TU1457R1</org_study_id>
    <nct_id>NCT02242110</nct_id>
  </id_info>
  <brief_title>Brief Treatment for Trauma Nightmares in Trauma-exposed Adults With Bipolar Disorder</brief_title>
  <acronym>BERRT</acronym>
  <official_title>Efficacy of a Brief Treatment for Chronic Nightmares Among Trauma-Exposed Persons With Bipolar Disorder</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>
      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 shown strong support in reducing the number and&#xD;
      intensity of nightmares, as well as improving overall sleep quality in both civilian and&#xD;
      veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar&#xD;
      disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study will examine the efficacy of Exposure, Relaxation, &amp; Rescripting Therapy&#xD;
      (ERRT) on chronic nightmares in trauma-exposed adults diagnosed with bipolar disorder&#xD;
      (B-ERRT), as these individuals have been excluded from past clinical trials. Eligible&#xD;
      participants will be assessed prior to starting treatment. B-ERRT will be conducted once a&#xD;
      week for approximately five consecutive weeks for approximately two hours per session. Each&#xD;
      treatment session focuses on one of the following topics/skills: psychoeducation regarding&#xD;
      trauma, nightmares, and sleep disturbances on bipolar disorder, relaxation techniques,&#xD;
      exposure to the trauma-nightmare, and relapse prevention. Participants will then be asked to&#xD;
      complete two to three follow-up assessments, 1-week, 3-months, and potentially 1-year after&#xD;
      the end of the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">May 2027</completion_date>
  <primary_completion_date type="Anticipated">May 2027</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Past Week Nightmare Frequency</measure>
    <time_frame>Pre, One week, Three Months</time_frame>
    <description>This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following treatment, and three months following treatment). Higher values indicate more nightmares (worse outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Clinician Administered PTSD Scale Symptoms</measure>
    <time_frame>Pre, One week, Three Months</time_frame>
    <description>This semi-structured clinical interview assesses severity of each of 30 items</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Nightmares</condition>
  <condition>Post-traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Nightmare Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The nightmare treatment, Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder (ERRT-Bipolar Disorder), is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ERRT-Bipolar Disorder</intervention_name>
    <description>The nightmare treatment, called Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder, is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.</description>
    <arm_group_label>Nightmare Treatment</arm_group_label>
    <other_name>ERRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nightmares at least once per week for the past month&#xD;
&#xD;
          -  Formal diagnosis of Bipolar disorder (I or II)&#xD;
&#xD;
          -  Exposure to traumatic event (1+ months ago)&#xD;
&#xD;
          -  Stable on bipolar medication for at least 2 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A traumatic event within the last month&#xD;
&#xD;
          -  Intellectual disability&#xD;
&#xD;
          -  Current or recent mania/hypomania within the last 3 months&#xD;
&#xD;
          -  Suicide attempt or hospitalization within the last 3 months&#xD;
&#xD;
          -  Current or untreated substance use disorder within the 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>918-631-3976</phone>
      <email>joanne-davis@utulsa.edu</email>
    </contact>
    <contact_backup>
      <last_name>Lucia D Villarreal, MS</last_name>
      <phone>918-379-0426</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 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 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>PI</investigator_title>
  </responsible_party>
  <keyword>Nightmares</keyword>
  <keyword>Sleep</keyword>
  <keyword>PTSD</keyword>
  <keyword>Exposure, Relaxation, and Rescripting Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Bipolar Disorder</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/NCT02242110
org study id: TU1457R1
nct id: NCT02242110
lead sponsor: 
has dmc: No
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 shown strong support in reducing the number and
      intensity of nightmares, as well as improving overall sleep quality in both civilian and
      veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar
      disorder.
This pilot study will examine the efficacy of Exposure, Relaxation, & Rescripting Therapy
      (ERRT) on chronic nightmares in trauma-exposed adults diagnosed with bipolar disorder
      (B-ERRT), as these individuals have been excluded from past clinical trials. Eligible
      participants will be assessed prior to starting treatment. B-ERRT will be conducted once a
      week for approximately five consecutive weeks for approximately two hours per session. Each
      treatment session focuses on one of the following topics/skills: psychoeducation regarding
      trauma, nightmares, and sleep disturbances on bipolar disorder, relaxation techniques,
      exposure to the trauma-nightmare, and relapse prevention. Participants will then be asked to
      complete two to three follow-up assessments, 1-week, 3-months, and potentially 1-year after
      the end of the treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Past Week Nightmare Frequency
time frame: Pre, One week, Three Months
description: This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following treatment, and three months following treatment). Higher values indicate more nightmares (worse outcome).
measure: Change in Clinician Administered PTSD Scale Symptoms
time frame: Pre, One week, Three Months
description: This semi-structured clinical interview assesses severity of each of 30 items
arm group label: Nightmare Treatment
arm group type: Experimental
description: The nightmare treatment, Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder (ERRT-Bipolar Disorder), is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.
intervention type: Behavioral
intervention name: ERRT-Bipolar Disorder
description: The nightmare treatment, called Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder, is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.
arm group label: Nightmare Treatment
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: PI
mesh term: Stress Disorders, Traumatic
mesh term: Bipolar Disorder
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No