<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/NCT01685528</url>
  </required_header>
  <id_info>
    <org_study_id>H-30655</org_study_id>
    <nct_id>NCT01685528</nct_id>
  </id_info>
  <brief_title>VA Home-Based Emotional Learning With Practical Skills</brief_title>
  <acronym>VA-HELPS</acronym>
  <official_title>VA Home-Based Emotional Learning With Practical Skills (VA-HELPS): Treatment for Depressed and/or Anxious Rural Veterans in Home-Based Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South Central VA Mental Illness Research, Education &amp; Clinical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the feasibility and acceptability of providing&#xD;
      evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression&#xD;
      via telephone to rural Veterans receiving home-based primary care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      VA-HELPS will include flexibility in both content and delivery to meet the needs of Home&#xD;
      Based Primary Care (HBPC) Veterans. Content will be modular to meet the needs of both anxious&#xD;
      and depressed participants. Modular skills-based treatment has been used successfully with a&#xD;
      range of clinical problems (Chorpita et al., 2004; Henin et al., 2001; Wetherell et al.,&#xD;
      2009, 2011), including our own group's work treating generalized anxiety disorder (GAD) in&#xD;
      primary care (Calleo et al., in press) and anxiety-depression in patients with chronic&#xD;
      illness (Cully et al., 2010). To further support a patient-centered treatment approach,&#xD;
      patients will have the opportunity to include R/S. Research points to the importance of R/S&#xD;
      in coping with illness, with 50-90% of patients reporting using their belief systems to&#xD;
      enhance coping skills (Koenig &amp; Adams, 2008). Along with content modifications, delivery of&#xD;
      treatment should complement the needs of HBPC Veterans. Providing one initial in-home&#xD;
      session, followed by telephone contact for subsequent sessions, allows cost effectiveness to&#xD;
      be taken into consideration; and greater numbers of rural HBPC patients will have access to&#xD;
      the intervention.&#xD;
&#xD;
      Treatment will involve approximately 6 to 8 weekly sessions lasting approximately 30-40&#xD;
      minutes each. After the first in-person session, all sessions will be delivered via&#xD;
      telephone. At least one booster call (15-20 minutes) will occur during the month following&#xD;
      completion of active treatment. All participants will complete assessments at baseline, 8&#xD;
      weeks, and 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Geriatric Anxiety Inventory</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Penn State Worry Questionnaire (PSWQ-A)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder-7</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-12 Health Survey</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief RCOPE</measure>
    <time_frame>12 weeks</time_frame>
    <description>A measure of positive and negative forms of religious coping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Multidimensional Measure of Religiousness and Spirituality</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT</intervention_name>
    <description>6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone</description>
    <arm_group_label>CBT</arm_group_label>
    <other_name>Cognitive Behavior Treatment, Cognitive Behavior Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Part of Home-Based Primary Care&#xD;
&#xD;
          -  Reside in a rural community, as defined by the US Census Bureau&#xD;
&#xD;
          -  Symptoms of anxiety and/or depression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive impairment&#xD;
&#xD;
          -  Active suicidal intent&#xD;
&#xD;
          -  Current uncontrolled psychosis, bipolar, or substance-abuse disorders within the past&#xD;
             month&#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>Melinda A Stanley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Houston Center for Quality of Care and Utilization Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>April 5, 2016</last_update_submitted>
  <last_update_submitted_qc>April 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Melinda Stanley</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Geriatric</keyword>
  <keyword>Veteran</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT01685528
org study id: H-30655
nct id: NCT01685528
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the feasibility and acceptability of providing
      evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression
      via telephone to rural Veterans receiving home-based primary care.
VA-HELPS will include flexibility in both content and delivery to meet the needs of Home
      Based Primary Care (HBPC) Veterans. Content will be modular to meet the needs of both anxious
      and depressed participants. Modular skills-based treatment has been used successfully with a
      range of clinical problems (Chorpita et al., 2004; Henin et al., 2001; Wetherell et al.,
      2009, 2011), including our own group's work treating generalized anxiety disorder (GAD) in
      primary care (Calleo et al., in press) and anxiety-depression in patients with chronic
      illness (Cully et al., 2010). To further support a patient-centered treatment approach,
      patients will have the opportunity to include R/S. Research points to the importance of R/S
      in coping with illness, with 50-90% of patients reporting using their belief systems to
      enhance coping skills (Koenig & Adams, 2008). Along with content modifications, delivery of
      treatment should complement the needs of HBPC Veterans. Providing one initial in-home
      session, followed by telephone contact for subsequent sessions, allows cost effectiveness to
      be taken into consideration; and greater numbers of rural HBPC patients will have access to
      the intervention.

      Treatment will involve approximately 6 to 8 weekly sessions lasting approximately 30-40
      minutes each. After the first in-person session, all sessions will be delivered via
      telephone. At least one booster call (15-20 minutes) will occur during the month following
      completion of active treatment. All participants will complete assessments at baseline, 8
      weeks, and 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Geriatric Anxiety Inventory
time frame: 12 weeks
measure: Penn State Worry Questionnaire (PSWQ-A)
time frame: 12 weeks
measure: Generalized Anxiety Disorder-7
time frame: 12 weeks
measure: SF-12 Health Survey
time frame: 12 weeks
measure: Brief RCOPE
time frame: 12 weeks
description: A measure of positive and negative forms of religious coping
measure: Client Satisfaction Questionnaire
time frame: 12 weeks
measure: Patient Health Questionnaire-9
time frame: 12 weeks
measure: Geriatric Depression Scale
time frame: 12 weeks
measure: Working Alliance Inventory
time frame: 12 weeks
measure: Brief Multidimensional Measure of Religiousness and Spirituality
time frame: 12 weeks
measure: Insomnia Severity Index
time frame: 12 weeks
arm group label: CBT
arm group type: Experimental
intervention type: Behavioral
intervention name: CBT
description: 6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone
arm group label: CBT
other name: Cognitive Behavior Treatment, Cognitive Behavior Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melinda A Stanley, PhD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Melinda Stanley
investigator title: Professor
mesh term: Depression