<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/NCT01686438</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 11-296</org_study_id>
    <nct_id>NCT01686438</nct_id>
  </id_info>
  <brief_title>Telemedicine Management of Chronic Insomnia</brief_title>
  <acronym>VIP</acronym>
  <official_title>Telemedicine Management of Veterans With PTSD and Chronic Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD).&#xD;
      Treatment of insomnia with a specialized type of psychotherapy has been shown to be more&#xD;
      effective than treatment with medications. Unfortunately, few psychologists are trained to&#xD;
      provide this treatment, limiting Veterans' access to care, especially those Veterans in&#xD;
      remote and rural areas. This project will evaluate the ability to deliver this psychotherapy&#xD;
      to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic&#xD;
      insomnia will receive the psychotherapy treatment either by meeting in-person with the&#xD;
      psychologist or by the psychologist delivering the treatment by video teleconferencing.&#xD;
      Finding that video teleconferencing is a cost effective way to deliver this treatment could&#xD;
      add an important new component to the care of Veterans with PTSD that provides an alternative&#xD;
      to medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives(s): The investigators are conducting a randomized, controlled trial of Veterans&#xD;
      with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia&#xD;
      (CBT-I) administered by video teleconferencing is not clinically inferior to in-person&#xD;
      treatment in terms of improvement in insomnia symptoms. Secondary aims are 1) comparing the&#xD;
      differences in cost and quality-adjusted life years between the treatment delivery approaches&#xD;
      and 2) determining the effectiveness of CBT-I on functional outcomes, sleep quality, and&#xD;
      non-sleep-related PTSD symptoms. The investigators are also conducting a patient- and&#xD;
      provider-focused formative evaluation of CBT-I delivery by video teleconferencing to assess&#xD;
      potential barriers to its widespread implementation.&#xD;
&#xD;
      Research Design: This prospective randomized controlled non-inferiority study will determine&#xD;
      if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an&#xD;
      improvement in insomnia severity, as determined by change in Insomnia Severity Index (ISI)&#xD;
      score, that is not clinically inferior to that in Veterans receiving in-person CBT-I.&#xD;
      Differences in cost and quality-adjusted life years (QALY) between groups will also be&#xD;
      compared.&#xD;
&#xD;
      Methodology: Veterans with PTSD and chronic insomnia receiving their primary care at&#xD;
      community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC are be&#xD;
      randomized to receive one of the following interventions in a group setting at their CBOC: 1)&#xD;
      a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program&#xD;
      delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active&#xD;
      control intervention. Participants are assessed at baseline, and 2 weeks and every 3 months&#xD;
      following the intervention. The primary outcome measure in Aim 1 is the change in the&#xD;
      Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority&#xD;
      analysis will be used to compare the effectiveness of the two delivery methods, with a&#xD;
      pre-specified margin. Results will be ascertained via intent to treat and per-protocol&#xD;
      procedures. The investigators hypothesize that the change in ISI score following CBT-I by&#xD;
      video teleconferencing will not be clinically inferior to that following in-person delivery.&#xD;
      In Aim 2, VA and non-VA total healthcare costs are being collected to test whether average&#xD;
      cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care.&#xD;
      Preference is being assessed by the EuroQol and Health Utilities Index 2. Differences in the&#xD;
      ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing&#xD;
      and in-person encounter will be compared to test the hypothesis that video teleconferencing&#xD;
      will have lower cost and equivalent outcomes. Aim 3 is assessing the effect of CBT-I on&#xD;
      functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality&#xD;
      (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the&#xD;
      non-sleep component of the PTSD Checklist-Military). The investigators hypothesize that these&#xD;
      functional outcomes and sleep quality measures will improve following each method of CBT-I&#xD;
      delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative&#xD;
      evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative (targeted&#xD;
      focus groups with participants and therapist interviews) and quantitative measures (Work&#xD;
      Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future&#xD;
      implementation of CBT-I by video teleconferencing&#xD;
&#xD;
      Anticipated Findings: The investigators believe these results will demonstrate that: 1)&#xD;
      Veterans in both CBT-I groups will have similar improvement in functional outcomes, and 2)&#xD;
      treatment delivery by video teleconferencing will be more cost effective than in-person care.&#xD;
      These findings should lead to wider acceptance of video teleconferencing, thereby increasing&#xD;
      patient access to care and reducing treatment costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2013</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</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 From Baseline in Insomnia Severity Index Score</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline PTSD Checklist-Military (PCL-M) Scores</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score &lt; 5 is associated with good sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Nightmare Distress Questionnaire Scores</measure>
    <time_frame>baseline to 3 month</time_frame>
    <description>Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Work and Social Adjustment Scale Scores</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks</measure>
    <time_frame>2-8 weeks</time_frame>
    <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks</measure>
    <time_frame>2-8 weeks</time_frame>
    <description>Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores</measure>
    <time_frame>baseline to 3 months, scores converted to yearly</time_frame>
    <description>Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores</measure>
    <time_frame>baseline to 3 months (converted to yearly)</time_frame>
    <description>Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks</measure>
    <time_frame>2-8 weeks</time_frame>
    <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks</measure>
    <time_frame>2-8 weeks</time_frame>
    <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <condition>Post-Traumatic Stress Disorders</condition>
  <arm_group>
    <arm_group_label>CBT-I delivery by video teleconferencing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groups of participants will receive a cognitive behavioral therapy for insomnia program delivered by a trained psychologist using video teleconferencing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-person CBT-I delivery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Groups of participants will receive a cognitive behavioral therapy for insomnia (CBT-I) program by meeting in-person with a trained psychologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy for insomnia</intervention_name>
    <description>A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.</description>
    <arm_group_label>CBT-I delivery by video teleconferencing</arm_group_label>
    <arm_group_label>In-person CBT-I delivery</arm_group_label>
    <other_name>CBT-I</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Veterans will have to meet the following inclusion criteria in order to be enrolled in this&#xD;
        RCT:&#xD;
&#xD;
          -  Men and women at least 18 years of age.&#xD;
&#xD;
          -  Meet current DSM-IV-TR criteria for PTSD as determined by the Clinician Administered&#xD;
             PTSD Scale (CAPS)&#xD;
&#xD;
          -  Insomnia Severity Index score &gt; 14, the commonly used threshold for clinical insomnia,&#xD;
             with self-reported duration of insomnia &gt;6 months.&#xD;
&#xD;
          -  Ability to read and speak English (assessment instruments and therapy will be&#xD;
             available only in English)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Veterans will be excluded from participation if they meet any of the following exclusion&#xD;
        criteria:&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent.&#xD;
&#xD;
          -  Unwilling to participate in supervised group sessions at the community based&#xD;
             outpatient clinic&#xD;
&#xD;
          -  No telephone access or inability to return for follow-up testing.&#xD;
&#xD;
          -  Individuals with an untreated sleep disorder [e.g., obstructive sleep apnea&#xD;
             (apnea-hypopnea index 15 events/hr), periodic limb movement disorder (10 leg&#xD;
             movements/hr of sleep with arousals), central sleep apnea ( 50% of apneas are&#xD;
             central), Cheyne-Stokes respiration, obesity hypoventilation syndrome, and&#xD;
             narcolepsy].&#xD;
&#xD;
          -  A clinically unstable medical condition as defined by a new diagnosis or change in&#xD;
             medical management in the previous 2 months.&#xD;
&#xD;
          -  Evidence of substance dependence during the preceding twelve months. Evidence of &quot;at&#xD;
             risk&quot; drinking behavior over the past month. Namely for men: more than 4 drinks on a&#xD;
             given night, drinking on more than 3 nights a week, or more than 14 total drinks in a&#xD;
             week; for women: more than 3 drinks in a given night, drinking on more than 3 nights a&#xD;
             week, or more than 7 total drinks in a week.&#xD;
&#xD;
          -  Individuals with bipolar disorder, delirium, dementia, amnestic disorder,&#xD;
             schizophrenia and other psychotic disorders as determined by the SCID questionnaire. A&#xD;
             concurrent anxiety disorder or depressive disorder diagnosis will be allowed.&#xD;
&#xD;
          -  Individuals with prominent current suicidal or homicidal ideation. This will be&#xD;
             assessed by the clinical psychologist administering the SCID and CAPS. In cases of&#xD;
             prominent current suicidal or homicidal ideation appropriate safety measures will be&#xD;
             taken. Following stabilization, Veterans who continue to be interested in&#xD;
             participating in the study may be re-assessed.&#xD;
&#xD;
          -  Unable to perform tests due to inability to communicate verbally, inability to read&#xD;
             and write; less than a 5th grade reading level; visual, hearing or cognitive&#xD;
             impairment (e.g., previous head injury).&#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>Samuel T. Kuna, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Philadelphia VA Medical Center, Philadelphia, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Philadelphia VA Medical Center, Philadelphia, PA</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Gehrman P, Shah MT, Miles A, Kuna S, Godleski L. Feasibility of Group Cognitive-Behavioral Treatment of Insomnia Delivered by Clinical Video Telehealth. Telemed J E Health. 2016 Dec;22(12):1041-1046. doi: 10.1089/tmj.2016.0032. Epub 2016 Jun 10.</citation>
    <PMID>27286369</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>February 7, 2019</results_first_submitted>
  <results_first_submitted_qc>July 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 29, 2019</results_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cost effectiveness</keyword>
  <keyword>patient satisfaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>114 participants were consented and randomized in the study. 87 of those participants started in treatment in this study. Of those, 57 completed treatment sessions. 55 of the 57 who completed treatment are included in the analysis of this study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Non-active intervention of sleep education delivered in-person</description>
        </group>
        <group group_id="P2">
          <title>CBT-I In-person</title>
          <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
        </group>
        <group group_id="P3">
          <title>CBT-I Telehealth</title>
          <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>2-Week Follow Up</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3-Month Follow Up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6-Month Follow Up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>patients who attended over 3 sessions and had a non-missing 3 month visit</population>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Non-active intervention of sleep education delivered in-person</description>
        </group>
        <group group_id="B2">
          <title>CBT-I In-person</title>
          <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
        </group>
        <group group_id="B3">
          <title>CBT-I Telehealth</title>
          <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="23"/>
            <count group_id="B4" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.57" spread="10.05"/>
                    <measurement group_id="B2" value="56.16" spread="10.84"/>
                    <measurement group_id="B3" value="56.57" spread="11.24"/>
                    <measurement group_id="B4" value="56.89" spread="10.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unavailable (do not wish to provide information)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.05" spread="2.79"/>
                    <measurement group_id="B2" value="34.02" spread="6.77"/>
                    <measurement group_id="B3" value="34.31" spread="4.97"/>
                    <measurement group_id="B4" value="33.89" spread="5.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Insomnia Severity Index Score</title>
        <description>Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.</description>
        <time_frame>Baseline to 3 months</time_frame>
        <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations). This analysis was intended to only compare the two CBT-I groups for non-inferiority analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Insomnia Severity Index Score</title>
          <description>Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.</description>
          <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations). This analysis was intended to only compare the two CBT-I groups for non-inferiority analysis.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.68" spread="1.09"/>
                    <measurement group_id="O2" value="5.13" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing will be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I.</non_inferiority_desc>
            <p_value>0.138</p_value>
            <method>t-test, 1 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.03</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.33</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.63</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline PTSD Checklist-Military (PCL-M) Scores</title>
        <description>Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.</description>
        <time_frame>baseline to 3 months</time_frame>
        <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline PTSD Checklist-Military (PCL-M) Scores</title>
          <description>Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.</description>
          <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.30" spread="3.33"/>
                    <measurement group_id="O2" value="5.73" spread="1.87"/>
                    <measurement group_id="O3" value="5.22" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores</title>
        <description>Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score &lt; 5 is associated with good sleep quality.</description>
        <time_frame>baseline to 3 months</time_frame>
        <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores</title>
          <description>Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score &lt; 5 is associated with good sleep quality.</description>
          <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" spread="1.36"/>
                    <measurement group_id="O2" value="3.34" spread="0.71"/>
                    <measurement group_id="O3" value="2.50" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)</title>
        <description>Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.</description>
        <time_frame>baseline to 3 months</time_frame>
        <population>Patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)</title>
          <description>Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.</description>
          <population>Patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="1.13"/>
                    <measurement group_id="O2" value="0.23" spread="0.66"/>
                    <measurement group_id="O3" value="0.51" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Nightmare Distress Questionnaire Scores</title>
        <description>Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.</description>
        <time_frame>baseline to 3 month</time_frame>
        <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Nightmare Distress Questionnaire Scores</title>
          <description>Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.</description>
          <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.78" spread="1.67"/>
                    <measurement group_id="O2" value="-2.65" spread="0.98"/>
                    <measurement group_id="O3" value="-0.11" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score</title>
        <description>Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.</description>
        <time_frame>baseline to 3 months</time_frame>
        <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score</title>
          <description>Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.</description>
          <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="2.79"/>
                    <measurement group_id="O2" value="0.70" spread="1.55"/>
                    <measurement group_id="O3" value="2.76" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score</title>
        <description>self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.</description>
        <time_frame>baseline to 3 months</time_frame>
        <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score</title>
          <description>self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.</description>
          <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.31" spread="2.24"/>
                    <measurement group_id="O2" value="-1.37" spread="1.22"/>
                    <measurement group_id="O3" value="0.14" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Work and Social Adjustment Scale Scores</title>
        <description>A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.</description>
        <time_frame>baseline to 3 months</time_frame>
        <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Work and Social Adjustment Scale Scores</title>
          <description>A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.</description>
          <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.54" spread="2.77"/>
                    <measurement group_id="O2" value="0.01" spread="1.46"/>
                    <measurement group_id="O3" value="-0.85" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks</title>
        <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
        <time_frame>2-8 weeks</time_frame>
        <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks</title>
          <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
          <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5" spread="6.24"/>
                    <measurement group_id="O2" value="76.8" spread="5.02"/>
                    <measurement group_id="O3" value="74.1" spread="8.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks</title>
        <description>Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.</description>
        <time_frame>2-8 weeks</time_frame>
        <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks</title>
          <description>Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.</description>
          <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5" spread="6.54"/>
                    <measurement group_id="O2" value="46.7" spread="9.09"/>
                    <measurement group_id="O3" value="44.8" spread="12.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores</title>
        <description>Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.</description>
        <time_frame>baseline to 3 months, scores converted to yearly</time_frame>
        <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores</title>
          <description>Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.</description>
          <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.</population>
          <units>nights per year</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.1" spread="20.13"/>
                    <measurement group_id="O2" value="11.35" spread="11.39"/>
                    <measurement group_id="O3" value="-3.04" spread="12.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores</title>
        <description>Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly</description>
        <time_frame>baseline to 3 months (converted to yearly)</time_frame>
        <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores</title>
          <description>Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly</description>
          <population>Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.</population>
          <units>number of nightmares</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.6" spread="23.87"/>
                    <measurement group_id="O2" value="6.41" spread="13.48"/>
                    <measurement group_id="O3" value="-8.09" spread="15.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks</title>
        <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
        <time_frame>2-8 weeks</time_frame>
        <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks</title>
          <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
          <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.8" spread="11.15"/>
                    <measurement group_id="O2" value="77.4" spread="7.57"/>
                    <measurement group_id="O3" value="76.8" spread="8.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks</title>
        <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
        <time_frame>2-8 weeks</time_frame>
        <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Non-active intervention of sleep education delivered in-person</description>
          </group>
          <group group_id="O2">
            <title>CBT-I In-person</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
          </group>
          <group group_id="O3">
            <title>CBT-I Telehealth</title>
            <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
          </group>
        </group_list>
        <measure>
          <title>Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks</title>
          <description>The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.</description>
          <population>patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5" spread="10.15"/>
                    <measurement group_id="O2" value="75.8" spread="7.54"/>
                    <measurement group_id="O3" value="75.3" spread="10.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Duration of study, an average of 2.5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Non-active intervention of sleep education delivered in-person</description>
        </group>
        <group group_id="E2">
          <title>CBT-I In-person</title>
          <description>Cognitive behavior therapy for insomnia (CBT-I) delivered in-person</description>
        </group>
        <group group_id="E3">
          <title>CBT-I Telehealth</title>
          <description>Cognitive behavior therapy for insomnia (CBT-I) delivered via video teleconferencing</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>hospitalized for suicide ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Tonsillectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Samuel T. Kuna</name_or_title>
      <organization>Crescenz VA Medical Center</organization>
      <phone>215-823-4400</phone>
      <email>Samuel.Kuna@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01686438
org study id: IIR 11-296
nct id: NCT01686438
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD).
      Treatment of insomnia with a specialized type of psychotherapy has been shown to be more
      effective than treatment with medications. Unfortunately, few psychologists are trained to
      provide this treatment, limiting Veterans' access to care, especially those Veterans in
      remote and rural areas. This project will evaluate the ability to deliver this psychotherapy
      to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic
      insomnia will receive the psychotherapy treatment either by meeting in-person with the
      psychologist or by the psychologist delivering the treatment by video teleconferencing.
      Finding that video teleconferencing is a cost effective way to deliver this treatment could
      add an important new component to the care of Veterans with PTSD that provides an alternative
      to medications.
Objectives(s): The investigators are conducting a randomized, controlled trial of Veterans
      with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia
      (CBT-I) administered by video teleconferencing is not clinically inferior to in-person
      treatment in terms of improvement in insomnia symptoms. Secondary aims are 1) comparing the
      differences in cost and quality-adjusted life years between the treatment delivery approaches
      and 2) determining the effectiveness of CBT-I on functional outcomes, sleep quality, and
      non-sleep-related PTSD symptoms. The investigators are also conducting a patient- and
      provider-focused formative evaluation of CBT-I delivery by video teleconferencing to assess
      potential barriers to its widespread implementation.

      Research Design: This prospective randomized controlled non-inferiority study will determine
      if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an
      improvement in insomnia severity, as determined by change in Insomnia Severity Index (ISI)
      score, that is not clinically inferior to that in Veterans receiving in-person CBT-I.
      Differences in cost and quality-adjusted life years (QALY) between groups will also be
      compared.

      Methodology: Veterans with PTSD and chronic insomnia receiving their primary care at
      community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC are be
      randomized to receive one of the following interventions in a group setting at their CBOC: 1)
      a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program
      delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active
      control intervention. Participants are assessed at baseline, and 2 weeks and every 3 months
      following the intervention. The primary outcome measure in Aim 1 is the change in the
      Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority
      analysis will be used to compare the effectiveness of the two delivery methods, with a
      pre-specified margin. Results will be ascertained via intent to treat and per-protocol
      procedures. The investigators hypothesize that the change in ISI score following CBT-I by
      video teleconferencing will not be clinically inferior to that following in-person delivery.
      In Aim 2, VA and non-VA total healthcare costs are being collected to test whether average
      cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care.
      Preference is being assessed by the EuroQol and Health Utilities Index 2. Differences in the
      ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing
      and in-person encounter will be compared to test the hypothesis that video teleconferencing
      will have lower cost and equivalent outcomes. Aim 3 is assessing the effect of CBT-I on
      functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality
      (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the
      non-sleep component of the PTSD Checklist-Military). The investigators hypothesize that these
      functional outcomes and sleep quality measures will improve following each method of CBT-I
      delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative
      evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative (targeted
      focus groups with participants and therapist interviews) and quantitative measures (Work
      Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future
      implementation of CBT-I by video teleconferencing

      Anticipated Findings: The investigators believe these results will demonstrate that: 1)
      Veterans in both CBT-I groups will have similar improvement in functional outcomes, and 2)
      treatment delivery by video teleconferencing will be more cost effective than in-person care.
      These findings should lead to wider acceptance of video teleconferencing, thereby increasing
      patient access to care and reducing treatment costs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Insomnia Severity Index Score
time frame: Baseline to 3 months
description: Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.
measure: Change From Baseline PTSD Checklist-Military (PCL-M) Scores
time frame: baseline to 3 months
description: Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.
measure: Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores
time frame: baseline to 3 months
description: Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score < 5 is associated with good sleep quality.
measure: Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
time frame: baseline to 3 months
description: Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.
measure: Change From Baseline in Nightmare Distress Questionnaire Scores
time frame: baseline to 3 month
description: Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.
measure: Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score
time frame: baseline to 3 months
description: Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.
measure: Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score
time frame: baseline to 3 months
description: self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.
measure: Change From Baseline in Work and Social Adjustment Scale Scores
time frame: baseline to 3 months
description: A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.
measure: Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks
time frame: 2-8 weeks
description: The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
measure: Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks
time frame: 2-8 weeks
description: Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.
measure: Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores
time frame: baseline to 3 months, scores converted to yearly
description: Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.
measure: Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores
time frame: baseline to 3 months (converted to yearly)
description: Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly
measure: Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks
time frame: 2-8 weeks
description: The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
measure: Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks
time frame: 2-8 weeks
description: The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
arm group label: CBT-I delivery by video teleconferencing
arm group type: Experimental
description: Groups of participants will receive a cognitive behavioral therapy for insomnia program delivered by a trained psychologist using video teleconferencing.
arm group label: In-person CBT-I delivery
arm group type: Active Comparator
description: Groups of participants will receive a cognitive behavioral therapy for insomnia (CBT-I) program by meeting in-person with a trained psychologist.
intervention type: Behavioral
intervention name: Cognitive behavioral therapy for insomnia
description: A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
arm group label: CBT-I delivery by video teleconferencing
arm group label: In-person CBT-I delivery
other name: CBT-I
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel T. Kuna, MD
role: Principal Investigator
affiliation: Philadelphia VA Medical Center, Philadelphia, PA
facility: 
country: United States
citation: Gehrman P, Shah MT, Miles A, Kuna S, Godleski L. Feasibility of Group Cognitive-Behavioral Treatment of Insomnia Delivered by Clinical Video Telehealth. Telemed J E Health. 2016 Dec;22(12):1041-1046. doi: 10.1089/tmj.2016.0032. Epub 2016 Jun 10.
PMID: 27286369
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 