<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/NCT03831412</url>
  </required_header>
  <id_info>
    <org_study_id>TU1802</org_study_id>
    <nct_id>NCT03831412</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy</brief_title>
  <official_title>CBT-I Versus ERRT: Impact on Sleep, Nightmares, and Suicidal Ideation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this project is to determine if directly addressing disturbed sleep and&#xD;
      nightmares will impact client reports of suicidal ideation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Insomnia Severity Index</measure>
    <time_frame>From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion</time_frame>
    <description>Change in frequency of insomnia symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Insomnia Severity Index</measure>
    <time_frame>From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion</time_frame>
    <description>Change in severity of insomnia symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sleep log</measure>
    <time_frame>From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion</time_frame>
    <description>Change in frequency of nightmares</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sleep log</measure>
    <time_frame>From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion</time_frame>
    <description>Change in severity of nightmares</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Beck Suicide Scale</measure>
    <time_frame>From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion</time_frame>
    <description>Change in severity of suicidal ideation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Insomnia</condition>
  <condition>Nightmare</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>CBT-I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 sessions of treating insomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 sessions of treating post-trauma nightmares</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-I</intervention_name>
    <description>Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.</description>
    <arm_group_label>CBT-I</arm_group_label>
    <other_name>Cognitive Behavioral Therapy for Insomnia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ERRT</intervention_name>
    <description>Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.</description>
    <arm_group_label>ERRT</arm_group_label>
    <other_name>Exposure, Relaxation, Rescripting Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  experiences at least one nightmare per week for the past month&#xD;
&#xD;
          -  having previously experienced a traumatic event&#xD;
&#xD;
          -  difficulty falling or staying asleep&#xD;
&#xD;
          -  suicidal ideation&#xD;
&#xD;
          -  actively under the care of another health care provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  untreated obstructive sleep apnea&#xD;
&#xD;
          -  acute or apparent psychosis&#xD;
&#xD;
          -  untreated or unstable bipolar disorder&#xD;
&#xD;
          -  past history of seizure disorder or neurological disorder&#xD;
&#xD;
          -  intellectual disability&#xD;
&#xD;
          -  current substance dependence or in past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lorton Hall</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://nightmaretreatment.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 27, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03831412
org study id: TU1802
nct id: NCT03831412
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this project is to determine if directly addressing disturbed sleep and
      nightmares will impact client reports of suicidal ideation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Insomnia Severity Index
time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
description: Change in frequency of insomnia symptoms
measure: Change in Insomnia Severity Index
time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
description: Change in severity of insomnia symptoms
measure: Change in Sleep log
time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
description: Change in frequency of nightmares
measure: Change in Sleep log
time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
description: Change in severity of nightmares
measure: Change in Beck Suicide Scale
time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
description: Change in severity of suicidal ideation
arm group label: CBT-I
arm group type: Active Comparator
description: 5 sessions of treating insomnia
arm group label: ERRT
arm group type: Active Comparator
description: 5 sessions of treating post-trauma nightmares
intervention type: Behavioral
intervention name: CBT-I
description: Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.
arm group label: CBT-I
other name: Cognitive Behavioral Therapy for Insomnia
intervention type: Behavioral
intervention name: ERRT
description: Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.
arm group label: ERRT
other name: Exposure, Relaxation, Rescripting Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: United States
url: http://nightmaretreatment.org
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University of Tulsa
investigator full name: Joanne Davis
investigator title: Professor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: Undecided