<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/NCT03798548</url>
  </required_header>
  <id_info>
    <org_study_id>32178</org_study_id>
    <nct_id>NCT03798548</nct_id>
  </id_info>
  <brief_title>Brief CBT for Patients Undergoing TAVR</brief_title>
  <official_title>Brief Cognitive Behavioral Therapy for Patients Undergoing Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adult patients scheduled to undergo TAVR were randomized to receive brief bedside cognitive&#xD;
      behavioral therapy for depression/anxiety or treatment as usual.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression and anxiety are common symptoms in patients undergoing cardiac surgery and&#xD;
      associated with increased cardiac morbidity and decreased functional status. Cognitive&#xD;
      behavioral therapy (CBT) has been shown to be an effective intervention to treat these&#xD;
      symptoms after cardiac surgery, but has not yet been studied in patients undergoing less&#xD;
      invasive cardiac procedures such as Transcatheter Aortic Valve Replacement (TAVR). This study&#xD;
      will examine the effect of CBT on symptoms of anxiety and depression in patients undergoing&#xD;
      TAVR.&#xD;
&#xD;
      The CBT protocol was loosely structured on the Managing Depression and Anxiety using&#xD;
      Education and Skills (MADES) protocol described in Dao and colleagues (2011). The current&#xD;
      intervention was designed to address the needs of individuals who may develop anxiety or&#xD;
      depression symptoms post-TAVR. The CBT intervention consisted of four 30 to 60-minute bedside&#xD;
      treatment sessions with a trained clinician while the participant was hospitalized for TAVR.&#xD;
&#xD;
      Main outcome measures were self-reported symptoms of depression and anxiety as measured by&#xD;
      the Beck Depression Inventory-II and State Trait Anxiety Inventory Form Y1. Secondary&#xD;
      outcomes included health related quality of life and hospital length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2015</start_date>
  <completion_date type="Actual">May 15, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Brief Bedside CBT versus Treatment As Usual</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Score on Beck Depression Inventory II (BDI-II)</measure>
    <time_frame>An average of 3 days post TAVR Procedure, 1-Month Follow Up</time_frame>
    <description>21-item self-report questionnaire with good reliability and validity in assessing symptoms of depression. Total score range 0-63 with higher scores indicating a worse outcome. Total BDI-II scores are interpreted as follows, 0-13: minimal, 14-19: mild, 20-28: moderate, 29-63: severe. In this study, a score of 14 or greater, and 20 or greater, were used define subpopulations with significant symptoms of depression on the BDI-II.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Score on State Trait Anxiety Inventory Form YI (STAI-YI)</measure>
    <time_frame>An average of 3 days post TAVR Procedure, 1-Month Follow Up</time_frame>
    <description>20-item self-report questionnaire with good internal consistency and construct validity in assessing symptoms of anxiety. Total score range 20-80 with higher scores indicating a worse outcome. The recommended cutoff score for clinically significant anxiety is 39 but a recent validity study of anxiety disorders in cardiac patients found ≥ 40 as an optimal cutoff score for screening the presence of an anxiety disorder. In this study, a score of 40 or greater, and 46 or greater, were used to define subpopulations with significant symptoms of anxiety on the STAI-Y1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Score on Minnesota Living With Heart Failure Questionnaire (MLHFQ)</measure>
    <time_frame>1-Month Follow Up</time_frame>
    <description>21-item self-report questionnaire designed to measure the effects of heart failure and treatments for heart failure on and individual's quality of life. Total score range 0-105. The total score is considered a measurement of heart failure severity as indicated by its adverse effect on the respondent's life over the past month. In this study, the MLHFQ total score was used as a continuous measure of heart failure related quality of life. Higher scores indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Score on 12-Item Short Form Health Survey (SF12v2)</measure>
    <time_frame>1-Month Follow Up</time_frame>
    <description>An abbreviated version of the 36-item Short Form Health Survey, which is a well-established measure assessing dimensions of mental and physical health. In this study, PCS and MCS summary scores were used as continuous measures of health-related quality of life. Scoring procedures involve computer-based scoring algorithms to calculate two summary scores, the physical component summary score (PCS) and mental component summary score (MCS), on a scale from 0 to 100 with a mean of 50 ± 10 that is normally distributed according to the adult U.S. population. Higher scores indicate a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Depression, Anxiety</condition>
  <arm_group>
    <arm_group_label>Brief Bedside CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment As Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Bedside CBT</intervention_name>
    <description>4 sessions of CBT including psychoeducation about TAVR and how mood can impact recovery in cardiac patients, discussion of patients' expectations and any concerns. Teaching and practice of cognitive restructuring and behavioral goal setting techniques for a healthy recovery.</description>
    <arm_group_label>Brief Bedside CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults 18 years of age and older&#xD;
&#xD;
          2. Voluntary participation&#xD;
&#xD;
          3. Informed consent obtained&#xD;
&#xD;
          4. Patients with severe aortic stenosis and high surgical risk who are undergoing TAVR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current psychiatric instability (eg., suicidality, schizophrenia, bipolar disorder,&#xD;
             active alcoholism or substance abuse)&#xD;
&#xD;
          2. Severe cognitive impairment, i.e. dementia&#xD;
&#xD;
          3. Life threatening co-morbidities&#xD;
&#xD;
          4. Inability to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://www.jtcvs.org/article/S0022-5223(11)00402-8/fulltext</url>
    <description>Link to Dao et al 2011</description>
  </link>
  <reference>
    <citation>Dao TK, Youssef NA, Armsworth M, Wear E, Papathopoulos KN, Gopaldas R. Randomized controlled trial of brief cognitive behavioral intervention for depression and anxiety symptoms preoperatively in patients undergoing coronary artery bypass graft surgery. J Thorac Cardiovasc Surg. 2011 Sep;142(3):e109-15. doi: 10.1016/j.jtcvs.2011.02.046. Epub 2011 May 28.</citation>
    <PMID>21621227</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>William Fearon</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>CBT</keyword>
  <keyword>Brief Therapy</keyword>
  <keyword>Bedside Intervention</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/NCT03798548
org study id: 32178
nct id: NCT03798548
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adult patients scheduled to undergo TAVR were randomized to receive brief bedside cognitive
      behavioral therapy for depression/anxiety or treatment as usual.
Depression and anxiety are common symptoms in patients undergoing cardiac surgery and
      associated with increased cardiac morbidity and decreased functional status. Cognitive
      behavioral therapy (CBT) has been shown to be an effective intervention to treat these
      symptoms after cardiac surgery, but has not yet been studied in patients undergoing less
      invasive cardiac procedures such as Transcatheter Aortic Valve Replacement (TAVR). This study
      will examine the effect of CBT on symptoms of anxiety and depression in patients undergoing
      TAVR.

      The CBT protocol was loosely structured on the Managing Depression and Anxiety using
      Education and Skills (MADES) protocol described in Dao and colleagues (2011). The current
      intervention was designed to address the needs of individuals who may develop anxiety or
      depression symptoms post-TAVR. The CBT intervention consisted of four 30 to 60-minute bedside
      treatment sessions with a trained clinician while the participant was hospitalized for TAVR.

      Main outcome measures were self-reported symptoms of depression and anxiety as measured by
      the Beck Depression Inventory-II and State Trait Anxiety Inventory Form Y1. Secondary
      outcomes included health related quality of life and hospital length of stay.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Brief Bedside CBT versus Treatment As Usual
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Change from Baseline Score on Beck Depression Inventory II (BDI-II)
time frame: An average of 3 days post TAVR Procedure, 1-Month Follow Up
description: 21-item self-report questionnaire with good reliability and validity in assessing symptoms of depression. Total score range 0-63 with higher scores indicating a worse outcome. Total BDI-II scores are interpreted as follows, 0-13: minimal, 14-19: mild, 20-28: moderate, 29-63: severe. In this study, a score of 14 or greater, and 20 or greater, were used define subpopulations with significant symptoms of depression on the BDI-II.
measure: Change from Baseline Score on State Trait Anxiety Inventory Form YI (STAI-YI)
time frame: An average of 3 days post TAVR Procedure, 1-Month Follow Up
description: 20-item self-report questionnaire with good internal consistency and construct validity in assessing symptoms of anxiety. Total score range 20-80 with higher scores indicating a worse outcome. The recommended cutoff score for clinically significant anxiety is 39 but a recent validity study of anxiety disorders in cardiac patients found ≥ 40 as an optimal cutoff score for screening the presence of an anxiety disorder. In this study, a score of 40 or greater, and 46 or greater, were used to define subpopulations with significant symptoms of anxiety on the STAI-Y1.
measure: Change from Baseline Score on Minnesota Living With Heart Failure Questionnaire (MLHFQ)
time frame: 1-Month Follow Up
description: 21-item self-report questionnaire designed to measure the effects of heart failure and treatments for heart failure on and individual's quality of life. Total score range 0-105. The total score is considered a measurement of heart failure severity as indicated by its adverse effect on the respondent's life over the past month. In this study, the MLHFQ total score was used as a continuous measure of heart failure related quality of life. Higher scores indicate a worse outcome.
measure: Change from Baseline Score on 12-Item Short Form Health Survey (SF12v2)
time frame: 1-Month Follow Up
description: An abbreviated version of the 36-item Short Form Health Survey, which is a well-established measure assessing dimensions of mental and physical health. In this study, PCS and MCS summary scores were used as continuous measures of health-related quality of life. Scoring procedures involve computer-based scoring algorithms to calculate two summary scores, the physical component summary score (PCS) and mental component summary score (MCS), on a scale from 0 to 100 with a mean of 50 ± 10 that is normally distributed according to the adult U.S. population. Higher scores indicate a better outcome.
arm group label: Brief Bedside CBT
arm group type: Experimental
arm group label: Treatment As Usual
arm group type: No Intervention
intervention type: Behavioral
intervention name: Brief Bedside CBT
description: 4 sessions of CBT including psychoeducation about TAVR and how mood can impact recovery in cardiac patients, discussion of patients' expectations and any concerns. Teaching and practice of cognitive restructuring and behavioral goal setting techniques for a healthy recovery.
arm group label: Brief Bedside CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: https://www.jtcvs.org/article/S0022-5223(11)00402-8/fulltext
description: Link to Dao et al 2011
citation: Dao TK, Youssef NA, Armsworth M, Wear E, Papathopoulos KN, Gopaldas R. Randomized controlled trial of brief cognitive behavioral intervention for depression and anxiety symptoms preoperatively in patients undergoing coronary artery bypass graft surgery. J Thorac Cardiovasc Surg. 2011 Sep;142(3):e109-15. doi: 10.1016/j.jtcvs.2011.02.046. Epub 2011 May 28.
PMID: 21621227
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: William Fearon
investigator title: Professor of Medicine
mesh term: Depression