<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/NCT02971150</url>
  </required_header>
  <id_info>
    <org_study_id>PRO0001567</org_study_id>
    <nct_id>NCT02971150</nct_id>
  </id_info>
  <brief_title>Treatment Resistant Depression and Insomnia in Older Veterans</brief_title>
  <official_title>Treatment Resistant Depression and Insomnia in Older Veterans: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Pittsburgh Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Pittsburgh Healthcare System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to obtain information about older Veterans' preferences&#xD;
      for treatment of depression and insomnia and to pilot test the feasibility and clinical&#xD;
      effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with&#xD;
      Treatment Resistant Depression (TRD) and insomnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Quantitative and qualitative methods will be used to obtain information to aid in developing&#xD;
      treatment approaches appropriate for older Veterans with TRD and insomnia. Qualitative data&#xD;
      will be gathered to better understand Veterans' preferences for treatment approaches,&#xD;
      particularly relating to preference for pharmacotherapy versus augmentation with a behavioral&#xD;
      intervention such as BBTI. Using a Randomized Controlled Trial (RCT) design, we will test&#xD;
      whether augmentation with BBTI will be acceptable to older Veterans and improve treatment&#xD;
      response in those whose depression has not improved with antidepressant pharmacotherapy alone&#xD;
      and assess for an association between preference and treatment response. Our aims and&#xD;
      hypotheses are:&#xD;
&#xD;
      Aim 1: To characterize the depression, insomnia, and relevant clinical and neuropsychiatric&#xD;
      characteristics of older Veterans with TRD.&#xD;
&#xD;
      H1a: In Veterans with TRD, Antidepressant History Form (ATHF) scores will have a positive&#xD;
      association with Montgomery-Asberg Depression Rating scale (MADRS) scores.&#xD;
&#xD;
      H1b: In Veterans with TRD, MADRS scores will have a positive association with Insomnia&#xD;
      Severity Index (ISI) scores.&#xD;
&#xD;
      Aim 2: Perform qualitative interviews in older Veterans to collect information about their&#xD;
      views of their depression and insomnia and attitudes and preferences for treatment of both&#xD;
      depression and insomnia.&#xD;
&#xD;
      Aim 3: To examine the feasibility of using BBTI to treat Veterans with TRD and insomnia.&#xD;
&#xD;
      H3a: Use of BBTI will be feasible in older adults with TRD as defined by acceptability and&#xD;
      retention.&#xD;
&#xD;
      Aim 4: To determine if antidepressant augmentation with BBTI leads to improvement in scores&#xD;
      on MADRS and ISI scales in older Veterans receiving BBTI versus those receiving only&#xD;
      antidepressant optimization.&#xD;
&#xD;
      H4a: Augmentation with BBTI will improve both PHQ-9 and ISI scores relative treatment with&#xD;
      antidepressant alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PHQ-9 ( depression)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ISI score ( insomnia)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form Survey (SF-12) SF-12 ( quality of life)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Closeness Questionnaire ( ECQ)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Treatment Resistant Depression</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>BBTI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Brief Behavioral Treatment for Insomnia (BBTI). This will be administered over the course of 4 weeks. BBTI is based on the concepts of sleep restriction and stimulus control. The first and third session are in person and the 2 and 4th session are conducted over the phone. Throughout the treatment, participants will complete daily sleep dairies. After 4 weeks of treatment, participants randomized to this group will cross over to the no intervention group and will be called once a week to assess mood and sleep symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not receive treatment. They will be contacted by phone once a week to complete assessments of mood and sleep. After 4 weeks, they will cross over to the experimental BBTI group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Behavioral Treatment for Insomnia</intervention_name>
    <arm_group_label>BBTI</arm_group_label>
    <other_name>BBTI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               -  Age ≥ 60&#xD;
&#xD;
               -  Diagnosis of Major Depressive Disorder (MDD)&#xD;
&#xD;
               -  Diagnosis of Insomnia Disorder&#xD;
&#xD;
               -  Must have failed ≥ 1 antidepressant trial&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
               -  Lifetime/current Bipolar I/II diagnosis&#xD;
&#xD;
               -  Lifetime/current Schizophrenia Spectrum Disorder diagnosis&#xD;
&#xD;
               -  Substance Use Disorder within past 3 months&#xD;
&#xD;
               -  High Suicide Risk that cannot be safely managed&#xD;
&#xD;
               -  Untreated Obstructive Sleep Apnea (OSA)&#xD;
&#xD;
               -  Restless Legs Syndrome&#xD;
&#xD;
               -  Rapid Eye Movement (REM) Sleep Behavior Disorder&#xD;
&#xD;
               -  Active OR untreated Post Traumatic Stress Disorder (PTSD)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Treatment-Resistant</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02971150
org study id: PRO0001567
nct id: NCT02971150
lead sponsor: 
has dmc: No
The purpose of this pilot study is to obtain information about older Veterans' preferences
      for treatment of depression and insomnia and to pilot test the feasibility and clinical
      effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with
      Treatment Resistant Depression (TRD) and insomnia.
Quantitative and qualitative methods will be used to obtain information to aid in developing
      treatment approaches appropriate for older Veterans with TRD and insomnia. Qualitative data
      will be gathered to better understand Veterans' preferences for treatment approaches,
      particularly relating to preference for pharmacotherapy versus augmentation with a behavioral
      intervention such as BBTI. Using a Randomized Controlled Trial (RCT) design, we will test
      whether augmentation with BBTI will be acceptable to older Veterans and improve treatment
      response in those whose depression has not improved with antidepressant pharmacotherapy alone
      and assess for an association between preference and treatment response. Our aims and
      hypotheses are:

      Aim 1: To characterize the depression, insomnia, and relevant clinical and neuropsychiatric
      characteristics of older Veterans with TRD.

      H1a: In Veterans with TRD, Antidepressant History Form (ATHF) scores will have a positive
      association with Montgomery-Asberg Depression Rating scale (MADRS) scores.

      H1b: In Veterans with TRD, MADRS scores will have a positive association with Insomnia
      Severity Index (ISI) scores.

      Aim 2: Perform qualitative interviews in older Veterans to collect information about their
      views of their depression and insomnia and attitudes and preferences for treatment of both
      depression and insomnia.

      Aim 3: To examine the feasibility of using BBTI to treat Veterans with TRD and insomnia.

      H3a: Use of BBTI will be feasible in older adults with TRD as defined by acceptability and
      retention.

      Aim 4: To determine if antidepressant augmentation with BBTI leads to improvement in scores
      on MADRS and ISI scales in older Veterans receiving BBTI versus those receiving only
      antidepressant optimization.

      H4a: Augmentation with BBTI will improve both PHQ-9 and ISI scores relative treatment with
      antidepressant alone.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PHQ-9 ( depression)
time frame: 8 weeks
measure: ISI score ( insomnia)
time frame: 8 weeks
measure: Short Form Survey (SF-12) SF-12 ( quality of life)
time frame: 8 weeks
measure: Emotional Closeness Questionnaire ( ECQ)
time frame: 8 weeks
arm group label: BBTI
arm group type: Experimental
description: Participants will receive Brief Behavioral Treatment for Insomnia (BBTI). This will be administered over the course of 4 weeks. BBTI is based on the concepts of sleep restriction and stimulus control. The first and third session are in person and the 2 and 4th session are conducted over the phone. Throughout the treatment, participants will complete daily sleep dairies. After 4 weeks of treatment, participants randomized to this group will cross over to the no intervention group and will be called once a week to assess mood and sleep symptoms.
arm group label: Control
arm group type: No Intervention
description: Participants will not receive treatment. They will be contacted by phone once a week to complete assessments of mood and sleep. After 4 weeks, they will cross over to the experimental BBTI group.
intervention type: Behavioral
intervention name: Brief Behavioral Treatment for Insomnia
arm group label: BBTI
other name: BBTI
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Treatment-Resistant
sharing ipd: Undecided