<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/NCT01694628</url>
  </required_header>
  <id_info>
    <org_study_id>43252</org_study_id>
    <nct_id>NCT01694628</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy for COPD</brief_title>
  <acronym>CLIMB</acronym>
  <official_title>Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study in patients with advanced COPD and depression is twofold:&#xD;
&#xD;
        1. Determine the feasibility and acceptability of a 6-session e-counseling intervention&#xD;
&#xD;
        2. Determine the efficacy of the e-counseling intervention on depressive symptoms&#xD;
&#xD;
      We hypothesize that patients who participate in e-counseling will have improved depressive&#xD;
      symptoms compared to patients receiving usual care at 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the&#xD;
      US. Although COPD is mostly preventable, there is no cure. Thus, care of patients with COPD&#xD;
      is primarily focused on symptom palliation with the goal of improving quality of life for&#xD;
      both patients and their families. These goals are highly consistent with core principles of&#xD;
      palliative care. Dyspnea is the most distressing symptom for patients. Even optimal&#xD;
      disease-directed treatment provides only partial relief from dyspnea. Depression is&#xD;
      consistently associated with worse dyspnea, but the mechanisms underlying this relationship&#xD;
      are poorly understood. Since existing treatment for dyspnea has only limited success and&#xD;
      there is evidence that treating depression alleviates pain, we propose that by improving&#xD;
      mood, we may be more successful in alleviating dyspnea. Psychosocial-behavioral therapy (PBT)&#xD;
      which is focused on increasing pleasant events and improving problem solving skills has been&#xD;
      shown to have immediate and sustained effects on depressive symptoms in patients with&#xD;
      dementia and post-stroke holds tremendous promise for efficacy in advanced COPD. Testing the&#xD;
      use of novel technologies to provide efficacious interventions such as PBT to patients with&#xD;
      advanced disease is critical for translational palliative care research&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>8 weeks</time_frame>
    <description>Personal Health Questionnaire-9</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyspnea Intensity and Distress</measure>
    <time_frame>8 weeks</time_frame>
    <description>Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>8 weeks</time_frame>
    <description>Chronic Respiratory Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>8 weeks</time_frame>
    <description>Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Accelerometry (Stepwatch)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>8 weeks</time_frame>
    <description>Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>COPD</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>CLIMB (COPD Lifestyle, Mood, and Behavior)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Counseling sessions for COPD and depression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CLIMB (COPD Lifestyle, Mood, and Behavior)</intervention_name>
    <description>Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.</description>
    <arm_group_label>CLIMB (COPD Lifestyle, Mood, and Behavior)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD (FEV1/FVC &lt; 70% &amp; FEV1 &lt;80%; current or past smoking &gt;10pack-years)&#xD;
&#xD;
          -  Depressed (PHQ-9 &gt;=10)&#xD;
&#xD;
          -  Ability to speak, read and write English&#xD;
&#xD;
          -  Willingness to use computer or study-issued tablet device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current non-nicotine substance abuse or dependence&#xD;
&#xD;
          -  Psychotic disorder&#xD;
&#xD;
          -  Active suicide ideation with intent and plan&#xD;
&#xD;
          -  Alzheimer's/dementia&#xD;
&#xD;
          -  Currently receiving any psychotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynn F Reinke, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Lynn Foster Reinke</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01694628
org study id: 43252
nct id: NCT01694628
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study in patients with advanced COPD and depression is twofold:

        1. Determine the feasibility and acceptability of a 6-session e-counseling intervention

        2. Determine the efficacy of the e-counseling intervention on depressive symptoms

      We hypothesize that patients who participate in e-counseling will have improved depressive
      symptoms compared to patients receiving usual care at 8 weeks.
Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the
      US. Although COPD is mostly preventable, there is no cure. Thus, care of patients with COPD
      is primarily focused on symptom palliation with the goal of improving quality of life for
      both patients and their families. These goals are highly consistent with core principles of
      palliative care. Dyspnea is the most distressing symptom for patients. Even optimal
      disease-directed treatment provides only partial relief from dyspnea. Depression is
      consistently associated with worse dyspnea, but the mechanisms underlying this relationship
      are poorly understood. Since existing treatment for dyspnea has only limited success and
      there is evidence that treating depression alleviates pain, we propose that by improving
      mood, we may be more successful in alleviating dyspnea. Psychosocial-behavioral therapy (PBT)
      which is focused on increasing pleasant events and improving problem solving skills has been
      shown to have immediate and sustained effects on depressive symptoms in patients with
      dementia and post-stroke holds tremendous promise for efficacy in advanced COPD. Testing the
      use of novel technologies to provide efficacious interventions such as PBT to patients with
      advanced disease is critical for translational palliative care research
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Depressive Symptoms
time frame: 8 weeks
description: Personal Health Questionnaire-9
measure: Dyspnea Intensity and Distress
time frame: 8 weeks
description: Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire
measure: Fatigue
time frame: 8 weeks
description: Chronic Respiratory Questionnaire
measure: Anxiety
time frame: 8 weeks
description: Hospital Anxiety and Depression Scale
measure: Physical Activity
time frame: 8 weeks
description: Accelerometry (Stepwatch)
measure: Quality of Life
time frame: 8 weeks
description: Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36
arm group label: CLIMB (COPD Lifestyle, Mood, and Behavior)
arm group type: Experimental
description: Counseling sessions for COPD and depression
arm group label: Control
arm group type: No Intervention
description: Usual Care
intervention type: Behavioral
intervention name: CLIMB (COPD Lifestyle, Mood, and Behavior)
description: Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.
arm group label: CLIMB (COPD Lifestyle, Mood, and Behavior)
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Lynn F Reinke, PhD, RN
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Lynn Foster Reinke
investigator title: Clinical Associate Professor
mesh term: Depression
sharing ipd: No