<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/NCT03261674</url>
  </required_header>
  <id_info>
    <org_study_id>B2319-I</org_study_id>
    <nct_id>NCT03261674</nct_id>
  </id_info>
  <brief_title>Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury</brief_title>
  <official_title>Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical trial is to assess the relative efficacy of two&#xD;
      non-pharmacological interventions for insomnia in Veterans suffering from chronic mild&#xD;
      traumatic brain injury (mTBI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insomnia is a serious health problem in Veterans suffering from chronic Traumatic Brain&#xD;
      Injury (TBI) and often associated with extensive prescription of sleeping medications.&#xD;
      Although safer, even the latest &quot;sleeping pills&quot; can lead to daytime impairment and risk of&#xD;
      abuse. Thus non-pharmacological treatments for insomnia have been pursued as alternatives to&#xD;
      medications. This trial will compare the relative efficacy of Cognitive Behavioral Therapy&#xD;
      for Insomnia (CBT-I) and Arousal-Based Therapy for Insomnia (ABT-I).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 28, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>
    <intervention_model_description>Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Change from baseline at week 8 after treatment</time_frame>
    <description>The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Insomnia</condition>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>CBTI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABTI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arousal-Based Therapy for Insomnia (ABT-I)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-I</intervention_name>
    <description>Cognitive Behavioral Therapy for Insomnia (CBT-I)</description>
    <arm_group_label>CBTI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ABT-I</intervention_name>
    <description>Arousal-Based Therapy for Insomnia (ABT-I)</description>
    <arm_group_label>ABTI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female chronic (&gt; 3 months since injury) mTBI Veterans of any racial or ethnic&#xD;
             group&#xD;
&#xD;
          -  Independent Living (not in nursing home or VA Extended Care facility)&#xD;
&#xD;
          -  Current chronic (3 months) subjective complaint of insomnia according to DUKE/DSM-5&#xD;
             criteria&#xD;
&#xD;
          -  Subjects with PTSD will be included in this study as long as they do not meet criteria&#xD;
             for depression described below&#xD;
&#xD;
          -  Use of CNS active medications that could significantly impact sleep or alertness is&#xD;
             allowed as long as the dose, timing, and formulation are stable (3 weeks)&#xD;
&#xD;
          -  Stable adult onset diabetes, controlled with insulin, oral medications or diet is&#xD;
             acceptable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Sleep-Related&#xD;
&#xD;
          -  Excessive caffeine consumption (5 cups of coffee per day) and unable to reduce to 3&#xD;
             cups before lunch a day for 3 weeks prior to treatment&#xD;
&#xD;
          -  Subjects will be initially screened by the Berlin Questionnaire (for sleep apnea) and&#xD;
             those with responses suggestive of high risk for sleep apnea, will be referred to&#xD;
             Pulmonary Medicine for standard clinical screening including polysomnography.&#xD;
&#xD;
          -  Subjects who have Obstructive Sleep Apnea (OSA) but who are adherent to CPAP will not&#xD;
             be excluded&#xD;
&#xD;
          -  Subjects working a rotating shift or an unconventional daytime shift (ending after&#xD;
             1700 h) will be ineligible&#xD;
&#xD;
        Neuropsychiatric&#xD;
&#xD;
          -  Current or lifetime history of a psychiatric disorder with primary psychotic features&#xD;
&#xD;
          -  Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation&#xD;
&#xD;
          -  Current exposure to trauma, or exposure to trauma in the past 3 months&#xD;
&#xD;
          -  Current or within the past 30 days: drug abuse or dependence (except nicotine)&#xD;
&#xD;
          -  Current or expected cognitive behavior therapy for another condition (e.g. depression)&#xD;
&#xD;
          -  More than one glass of wine or beer with dinner scheduled at least 3 to 4 hours before&#xD;
             bedtime&#xD;
&#xD;
          -  Presence of any acute or unstable psychiatric condition(s) that requires referral for&#xD;
             treatment&#xD;
&#xD;
          -  Folstein Mini-Mental State Exam (MMSE) &lt; 24 or TCogs &lt; 23&#xD;
&#xD;
        Medical&#xD;
&#xD;
          -  Acute or unstable chronic illness, including but not limited to:&#xD;
&#xD;
               -  uncontrolled thyroid disease&#xD;
&#xD;
               -  kidney&#xD;
&#xD;
               -  prostate or bladder conditions causing excessively frequent urination (&gt; 3 times&#xD;
                  per night)&#xD;
&#xD;
               -  medically unstable congestive heart failure&#xD;
&#xD;
               -  angina&#xD;
&#xD;
               -  other severe cardiac illness as defined by treatment regimen changes in the prior&#xD;
                  3 months&#xD;
&#xD;
               -  stroke with serious sequelae&#xD;
&#xD;
               -  cancer if &lt; 1 year since end of treatment&#xD;
&#xD;
               -  asthma&#xD;
&#xD;
               -  emphysema&#xD;
&#xD;
               -  or other severe respiratory diseases uncontrolled with medications&#xD;
&#xD;
               -  neurological disorders such as Alzheimer's disease, Parkinson's disease and&#xD;
                  unstable epilepsy as defined by treatment regimen changes in the prior 3 months&#xD;
&#xD;
               -  Unstable adult onset diabetes will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ansgar J. Furst, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Palo Alto Health Care System, Palo Alto, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System, Palo Alto, CA</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304-1207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Veterans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared through the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system: This system was developed to share data across the entire TBI research field and to facilitate collaboration between laboratories, as well as interconnectivity with other informatics platforms. Data will be uploaded to FITBIR according to the detailed instructions available on the FITBIR website.</ipd_description>
  </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/NCT03261674
org study id: B2319-I
nct id: NCT03261674
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this clinical trial is to assess the relative efficacy of two
      non-pharmacological interventions for insomnia in Veterans suffering from chronic mild
      traumatic brain injury (mTBI).
Insomnia is a serious health problem in Veterans suffering from chronic Traumatic Brain
      Injury (TBI) and often associated with extensive prescription of sleeping medications.
      Although safer, even the latest "sleeping pills" can lead to daytime impairment and risk of
      abuse. Thus non-pharmacological treatments for insomnia have been pursued as alternatives to
      medications. This trial will compare the relative efficacy of Cognitive Behavioral Therapy
      for Insomnia (CBT-I) and Arousal-Based Therapy for Insomnia (ABT-I).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Insomnia Severity Index (ISI)
time frame: Change from baseline at week 8 after treatment
description: The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change.
arm group label: CBTI
arm group type: Experimental
description: Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
arm group label: ABTI
arm group type: Experimental
description: Arousal-Based Therapy for Insomnia (ABT-I)
intervention type: Behavioral
intervention name: CBT-I
description: Cognitive Behavioral Therapy for Insomnia (CBT-I)
arm group label: CBTI
intervention type: Behavioral
intervention name: ABT-I
description: Arousal-Based Therapy for Insomnia (ABT-I)
arm group label: ABTI
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ansgar J. Furst, PhD
role: Principal Investigator
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: Data will be shared through the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system: This system was developed to share data across the entire TBI research field and to facilitate collaboration between laboratories, as well as interconnectivity with other informatics platforms. Data will be uploaded to FITBIR according to the detailed instructions available on the FITBIR website.