<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/NCT02248675</url>
  </required_header>
  <id_info>
    <org_study_id>PPO 13-373</org_study_id>
    <secondary_id>I21HX001473</secondary_id>
    <nct_id>NCT02248675</nct_id>
  </id_info>
  <brief_title>Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)</brief_title>
  <official_title>An Adjunctive Behavioral Sleep Intervention to Prevent Veteran Suicides</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a strong association between sleep disturbance and suicidal thoughts and behaviors.&#xD;
      Sleep disturbance is also highly comorbid with other common conditions associated with&#xD;
      suicide such as depression and posttraumatic stress disorder. Accordingly, this application&#xD;
      focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a&#xD;
      broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral&#xD;
      Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in&#xD;
      Veterans who also suffer from additional conditions. The proposal further suggests that&#xD;
      adding this sleep intervention to usual care may further enhance overall care by increasing&#xD;
      the utilization of recommended treatments for depression and posttraumatic stress disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anticipated Benefit to VA Healthcare The proposed study will establish proof of concept that&#xD;
      suicidal ideation can be reduced by adjunctively treating insomnia, a common problem that is&#xD;
      both a risk factor for suicide and highly prevalent in common conditions associated with&#xD;
      suicide such as depression and PTSD. In addition, to the extent that insomnia is improved,&#xD;
      the investigators expect to both enhance Veteran's quality of life and increase their&#xD;
      engagement with treatments for co-occurring conditions.&#xD;
&#xD;
      Project Background Suicide is the tenth leading cause of death in the U.S., is a major&#xD;
      concern of the Department of Veterans Affairs (VA), and occurs at elevated rates among&#xD;
      Veterans. Veterans with common chronic conditions such as PTSD, depression, substance abuse&#xD;
      and chronic pain are at increased risk for suicide. Although evidence-based treatments exist&#xD;
      for these conditions, a significant number of Veterans do not engage in or complete such&#xD;
      treatments. This application focuses on an intervention target that co-occurs in each of the&#xD;
      listed conditions at high rates and is itself an independent risk factor for suicidal&#xD;
      thoughts and behaviors: the sleep disturbance of insomnia. Therefore, this proposal examines&#xD;
      the use of cognitive-behavioral therapy for insomnia (CBT-I), an efficacious intervention&#xD;
      that targets insomnia, as a novel way to reduce suicidal ideation in at-risk Veterans.&#xD;
      Importantly, CBT-I has been successfully used in patients with PTSD and depression.&#xD;
      Preliminary evidence from an uncontrolled trial in civilians suggests that CBT-I may also&#xD;
      decrease suicidal ideation, but this has not been tested in Veterans, in the context of&#xD;
      treatments for co-occurring conditions, or in a controlled trial.&#xD;
&#xD;
      Project Objectives The ultimate goal of the broader program of research is to reduce suicide&#xD;
      among Veterans, while the proposed pilot project will provide data to guide the development&#xD;
      of a larger trial. The primary objectives of this pilot project are to test whether using&#xD;
      CBT-I as an adjunctive treatment: (1) is feasible to deliver in the context of other ongoing&#xD;
      care and acceptable to participants; (2) can reduce the severity of suicidal ideation among&#xD;
      Veterans at risk for suicide; and (3) can increase rates of engagement in treatments that&#xD;
      address the co-morbid conditions that also put them at risk for suicide. The latter objective&#xD;
      will help refine the study methods, design, and intervention in anticipation of a larger&#xD;
      trial.&#xD;
&#xD;
      Project Methods In order to achieve these proof-of-concept objectives the investigators will&#xD;
      conduct a small randomized clinical trial. Veterans who are either flagged as high risk for&#xD;
      suicide or who have depression or PTSD will be recruited from VA sites only. Approximately 56&#xD;
      such Veterans who also endorse current suicidal ideation and current insomnia will be&#xD;
      randomized to receive either treatment-as-usual or a 4-session CBT-I treatment in addition to&#xD;
      treatment-as-usual. All participants will be encouraged to continue or to seek treatment for&#xD;
      co-occurring conditions as recommended by their VA treatment providers. Assessments of&#xD;
      suicidal ideation, insomnia, depression, PTSD, and quality of life will be conducted at&#xD;
      baseline and following the treatment period. In addition, the investigators will collect&#xD;
      provider and participant feedback at an exit interview immediately following the&#xD;
      post-treatment assessment. The investigators will use multiple linear and logistic regression&#xD;
      models to assess the effect of treatment on outcome measures across the study assessment time&#xD;
      points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>post-treatment (~6-8 weeks)</time_frame>
    <description>The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived Treatment Beliefs (PTS)</measure>
    <time_frame>post-treatment (~6-8 weeks)</time_frame>
    <description>A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations. This measure will focus on engagement in PTSD and depression treatments. The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>post-treatment (~6-8 weeks)</time_frame>
    <description>A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>post-treatment (~6-8 weeks)</time_frame>
    <description>A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Insomnia</condition>
  <condition>Depression</condition>
  <condition>Posttraumatic Stress Disorder</condition>
  <condition>Suicidal Ideation</condition>
  <arm_group>
    <arm_group_label>CBT-I + TAU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-I</intervention_name>
    <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.</description>
    <arm_group_label>CBT-I + TAU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TAU</intervention_name>
    <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
    <arm_group_label>CBT-I + TAU</arm_group_label>
    <arm_group_label>TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking male and female Veterans ages 18-70;&#xD;
&#xD;
          -  demonstrate an understanding of the informed consent;&#xD;
&#xD;
          -  seeking or receiving services at the Canandaigua VA Medical Center (VAMC) or Rochester&#xD;
             Outpatient Clinic;&#xD;
&#xD;
          -  endorse death/suicidal ideation on the Columbia Suicide Severity Rating Scale&#xD;
&#xD;
          -  either (i) a current diagnosis in their medical record of Major Depressive Disorder,&#xD;
             Depression not otherwise specified, PTSD,or (ii) evidence of current depression as&#xD;
             indicated by a score of &gt; 10 on the Patient Health Questionnaire (PHQ-9) or current&#xD;
             PTSD as indicated by a score of &gt; 38 on the PTSD Symptom Checklist (PCL-5)();&#xD;
&#xD;
          -  have an Insomnia Severity Index score &gt; 10 indicating clinically meaningful insomnia&#xD;
             with at least 1 insomnia-related daytime consequence (score of 1 on item #3) and&#xD;
             trouble sleeping 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of serious mental illness such as schizophrenia, Bipolar I or II disorder, or&#xD;
             current psychiatric conditions such as psychosis, mania, dementia, cognitive&#xD;
             impairment, OR suicidal ideation with plan and intent, a report of a suicide attempt&#xD;
             in the past 6 months in the Computerized Patient Record System (CPRS) or via&#xD;
             self-report, or a score of 4 on the Columbia-Suicide Severity Rating Scale&#xD;
&#xD;
          -  currently engaged in inpatient or partial hospitalization programs or ongoing/pending&#xD;
             medical procedures that could inhibit sleep&#xD;
&#xD;
          -  recent substance dependence disorder with &lt; 3 months in remission or abstinence;&#xD;
&#xD;
          -  suspicion of or evidence of untreated sleep apnea.&#xD;
&#xD;
          -  Diagnosis of a circadian rhythm disorder&#xD;
&#xD;
          -  Diagnosis of Narcolepsy&#xD;
&#xD;
          -  History of Seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wilfred R Pigeon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Syracuse VA Medical Center, Syracuse, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Syracuse VA Medical Center, Syracuse, NY</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>January 24, 2017</results_first_submitted>
  <results_first_submitted_qc>March 17, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 28, 2017</results_first_posted>
  <last_update_submitted>March 17, 2017</last_update_submitted>
  <last_update_submitted_qc>March 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sleep disorders</keyword>
  <keyword>insomnia</keyword>
  <keyword>suicidal ideation</keyword>
  <keyword>Depression</keyword>
  <keyword>Depressive disorders</keyword>
  <keyword>PTSD</keyword>
  <keyword>anxiety disorders</keyword>
  <keyword>suicide</keyword>
  <keyword>cognitive behavioral therapy</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>Depression</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>581 potential participants were identified from medical records and received a recruitment letter from their current treatment provider; 420 were reachable and screened by phone with 71 meeting initial eligibility criteria, completing written informed consent and baseline interview. 54 participants met all eligibility criteria and were randomized.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>CBT-I + TAU</title>
          <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).&#xD;
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
        </group>
        <group group_id="P2">
          <title>TAU Control</title>
          <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </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="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CBT-I + TAU</title>
          <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).&#xD;
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
        </group>
        <group group_id="B2">
          <title>TAU Control</title>
          <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
        </group>
        <group group_id="B3">
          <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="26"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="54"/>
          </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="53.9" spread="14.1"/>
                    <measurement group_id="B2" value="57.2" spread="10.8"/>
                    <measurement group_id="B3" value="55.4" spread="12.5"/>
                  </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="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Columbia Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.</description>
        <time_frame>post-treatment (~6-8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CBT-I + TAU</title>
            <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).&#xD;
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
          </group>
          <group group_id="O2">
            <title>TAU Control</title>
            <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Columbia Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.</description>
          <units>units 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="23"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="6.8"/>
                    <measurement group_id="O2" value="8.4" spread="6.3"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>.153</p_value>
            <method>Regression, Linear</method>
            <method_desc>multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived Treatment Beliefs (PTS)</title>
        <description>A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations. This measure will focus on engagement in PTSD and depression treatments. The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.</description>
        <time_frame>post-treatment (~6-8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CBT-I + TAU</title>
            <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).&#xD;
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
          </group>
          <group group_id="O2">
            <title>TAU Control</title>
            <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Treatment Beliefs (PTS)</title>
          <description>A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations. This measure will focus on engagement in PTSD and depression treatments. The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.</description>
          <units>units 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="23"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135.7" spread="18.0"/>
                    <measurement group_id="O2" value="133.04" spread="28.8"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>.627</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Health Questionnaire-9 (PHQ-9)</title>
        <description>A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).</description>
        <time_frame>post-treatment (~6-8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CBT-I + TAU</title>
            <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).&#xD;
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
          </group>
          <group group_id="O2">
            <title>TAU Control</title>
            <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire-9 (PHQ-9)</title>
          <description>A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).</description>
          <units>units 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="23"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="4.6"/>
                    <measurement group_id="O2" value="12.3" spread="5.4"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insomnia Severity Index (ISI)</title>
        <description>A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).</description>
        <time_frame>post-treatment (~6-8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CBT-I + TAU</title>
            <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).&#xD;
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
          </group>
          <group group_id="O2">
            <title>TAU Control</title>
            <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Insomnia Severity Index (ISI)</title>
          <description>A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).</description>
          <units>units 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="23"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="5.5"/>
                    <measurement group_id="O2" value="17.8" spread="5.2"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During study participation of approximately 8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CBT-I + TAU</title>
          <description>Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).&#xD;
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
        </group>
        <group group_id="E2">
          <title>TAU Control</title>
          <description>Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.&#xD;
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.</description>
        </group>
      </group_list>
      <serious_events>
        <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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Wilfred R. Pigeon, PhD</name_or_title>
      <organization>VA Center of Excellence for Suicide Prevention</organization>
      <phone>(585) 393-7945</phone>
      <email>wilfred.pigeon2@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/NCT02248675
org study id: PPO 13-373
secondary id: I21HX001473
nct id: NCT02248675
lead sponsor: 
has dmc: No
There is a strong association between sleep disturbance and suicidal thoughts and behaviors.
      Sleep disturbance is also highly comorbid with other common conditions associated with
      suicide such as depression and posttraumatic stress disorder. Accordingly, this application
      focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a
      broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral
      Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in
      Veterans who also suffer from additional conditions. The proposal further suggests that
      adding this sleep intervention to usual care may further enhance overall care by increasing
      the utilization of recommended treatments for depression and posttraumatic stress disorder.
Anticipated Benefit to VA Healthcare The proposed study will establish proof of concept that
      suicidal ideation can be reduced by adjunctively treating insomnia, a common problem that is
      both a risk factor for suicide and highly prevalent in common conditions associated with
      suicide such as depression and PTSD. In addition, to the extent that insomnia is improved,
      the investigators expect to both enhance Veteran's quality of life and increase their
      engagement with treatments for co-occurring conditions.

      Project Background Suicide is the tenth leading cause of death in the U.S., is a major
      concern of the Department of Veterans Affairs (VA), and occurs at elevated rates among
      Veterans. Veterans with common chronic conditions such as PTSD, depression, substance abuse
      and chronic pain are at increased risk for suicide. Although evidence-based treatments exist
      for these conditions, a significant number of Veterans do not engage in or complete such
      treatments. This application focuses on an intervention target that co-occurs in each of the
      listed conditions at high rates and is itself an independent risk factor for suicidal
      thoughts and behaviors: the sleep disturbance of insomnia. Therefore, this proposal examines
      the use of cognitive-behavioral therapy for insomnia (CBT-I), an efficacious intervention
      that targets insomnia, as a novel way to reduce suicidal ideation in at-risk Veterans.
      Importantly, CBT-I has been successfully used in patients with PTSD and depression.
      Preliminary evidence from an uncontrolled trial in civilians suggests that CBT-I may also
      decrease suicidal ideation, but this has not been tested in Veterans, in the context of
      treatments for co-occurring conditions, or in a controlled trial.

      Project Objectives The ultimate goal of the broader program of research is to reduce suicide
      among Veterans, while the proposed pilot project will provide data to guide the development
      of a larger trial. The primary objectives of this pilot project are to test whether using
      CBT-I as an adjunctive treatment: (1) is feasible to deliver in the context of other ongoing
      care and acceptable to participants; (2) can reduce the severity of suicidal ideation among
      Veterans at risk for suicide; and (3) can increase rates of engagement in treatments that
      address the co-morbid conditions that also put them at risk for suicide. The latter objective
      will help refine the study methods, design, and intervention in anticipation of a larger
      trial.

      Project Methods In order to achieve these proof-of-concept objectives the investigators will
      conduct a small randomized clinical trial. Veterans who are either flagged as high risk for
      suicide or who have depression or PTSD will be recruited from VA sites only. Approximately 56
      such Veterans who also endorse current suicidal ideation and current insomnia will be
      randomized to receive either treatment-as-usual or a 4-session CBT-I treatment in addition to
      treatment-as-usual. All participants will be encouraged to continue or to seek treatment for
      co-occurring conditions as recommended by their VA treatment providers. Assessments of
      suicidal ideation, insomnia, depression, PTSD, and quality of life will be conducted at
      baseline and following the treatment period. In addition, the investigators will collect
      provider and participant feedback at an exit interview immediately following the
      post-treatment assessment. The investigators will use multiple linear and logistic regression
      models to assess the effect of treatment on outcome measures across the study assessment time
      points.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: post-treatment (~6-8 weeks)
description: The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.
measure: Perceived Treatment Beliefs (PTS)
time frame: post-treatment (~6-8 weeks)
description: A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations. This measure will focus on engagement in PTSD and depression treatments. The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: post-treatment (~6-8 weeks)
description: A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).
measure: Insomnia Severity Index (ISI)
time frame: post-treatment (~6-8 weeks)
description: A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).
arm group label: CBT-I + TAU
arm group type: Experimental
description: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
arm group label: TAU
arm group type: Active Comparator
description: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
intervention type: Behavioral
intervention name: CBT-I
description: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
arm group label: CBT-I + TAU
intervention type: Other
intervention name: TAU
description: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
arm group label: CBT-I + TAU
arm group label: TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Wilfred R Pigeon, PhD
role: Principal Investigator
affiliation: Syracuse VA Medical Center, Syracuse, NY
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression
mesh term: Stress Disorders, Post-Traumatic
mesh term: Suicidal Ideation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 