<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/NCT02997865</url>
  </required_header>
  <id_info>
    <org_study_id>R01HL131524</org_study_id>
    <secondary_id>R01HL131524</secondary_id>
    <nct_id>NCT02997865</nct_id>
  </id_info>
  <brief_title>Stepped Care for Depression in Heart Failure</brief_title>
  <acronym>DASH-2</acronym>
  <official_title>Stepped Care for Depression in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study evaluates stepped care for depression in patients with heart failure (HF). The&#xD;
      stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half&#xD;
      of the participants will receive stepped care and half will receive usual care for&#xD;
      depression; all participants will receive heart failure self-care education and support. The&#xD;
      primary aims are to determine whether stepped care is superior to usual care for depression,&#xD;
      and whether treating depression improves heart failure self-care outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is associated with poor heart failure self-care. Good self-care practices,&#xD;
      including following dietary recommendations, taking prescribed medications, monitoring&#xD;
      symptoms, and regular light exercise have been shown to improve quality of life and survival&#xD;
      in persons with heart failure.&#xD;
&#xD;
      Both CBT and antidepressant medications have been used in previous studies to treat major&#xD;
      depression in patients with heart failure. Participants in the intervention arm in this trial&#xD;
      will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT&#xD;
      may also be referred to their own physician to discuss antidepressant medications.&#xD;
&#xD;
      Heart failure self-care education and support will be provided after the first 8 weeks of the&#xD;
      depression intervention. The study will determine whether people with heart failure benefit&#xD;
      more from self-care education and support after their depression has been treated with a&#xD;
      stepped care intervention, as compared to usual care for depression as provided by primary&#xD;
      care providers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>Beck Depression Inventory (BDI-2) Total Score</measure>
    <time_frame>16 weeks</time_frame>
    <description>The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self Care of Heart Failure Index (SCHFI) Maintenance Subscale</measure>
    <time_frame>16 weeks</time_frame>
    <description>The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory</measure>
    <time_frame>16 weeks</time_frame>
    <description>The BAI measures the self-reported severity of anxiety symptoms. Total BAI scores range from 0 (best) to 63 (worst). A total score of 0-7 is considered nonanxious; scores between 8-15 are consistent with mild, 16-25 moderate, and 26-63 severe anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kansas City Cardiomyopathy Questionnaire (KCCQ)</measure>
    <time_frame>16 weeks</time_frame>
    <description>The KCCQ assesses the patient's self-reported, heart failure-related functioning and quality of life. Scores range from 0 (worst) to 100 (best). Scores between 0-24 are consistent with very poor to poor health status, 25-49 poor to fair health status, 50-74 fair to good health status, and 75-100 good to excellent health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Rating Scale for Depression (HAM-D-17)</measure>
    <time_frame>16 weeks</time_frame>
    <description>The Hamilton Rating Scale total score indicates the interviewer-rated severity of depression symptoms. Total scores can range from 0 to 52, with higher scores indicating worse depression. Patients who score 0-9 are considered to be nondepressed. Scores of 10-13 represent mild, 14-17 mild to moderate, and &gt;17 moderate to severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>16 weeks</time_frame>
    <description>Actigraphy was used to track the patient's physical activity level. However, actigraphy had to be discontinued during the first few months of the trial due to the COVID-19 pandemic.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Heart Failure</condition>
  <condition>Depressive Disorder, Major</condition>
  <arm_group>
    <arm_group_label>Stepped Care for Depression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive individually-tailored heart failure self-care education and support. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stepped care for depression</intervention_name>
    <description>Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
    <arm_group_label>Stepped Care for Depression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart&#xD;
             failure.&#xD;
&#xD;
          2. Current major depressive episode.&#xD;
&#xD;
          3. Baseline Beck Depression Inventory (BDI-II) score 14 or greater&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Dementia or other significant cognitive or communication deficits&#xD;
&#xD;
          2. Terminal illness other than HF&#xD;
&#xD;
          3. Insurmountable logistical barriers to participation&#xD;
&#xD;
          4. Age less than 25 years&#xD;
&#xD;
          5. Current clinically significant substance abuse, bipolar disorder, schizophrenia, or&#xD;
             other psychotic disorder&#xD;
&#xD;
          6. High risk of suicide&#xD;
&#xD;
          7. Current participation in non-study psychotherapy for depression or other psychiatric&#xD;
             conditions&#xD;
&#xD;
          8. Initiation or modification of antidepressant medication treatment within past two&#xD;
             months&#xD;
&#xD;
          9. Renal or hepatic conditions that would preclude the use of antidepressants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth E Freedland, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Behavioral Medicine Center Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rubin EH, Rich MW. Sequential Interventions for Major Depression and Heart Failure Self-Care: A Randomized Clinical Trial. Circ Heart Fail. 2022 Aug;15(8):e009422. doi: 10.1161/CIRCHEARTFAILURE.121.009422. Epub 2022 Jun 21.</citation>
    <PMID>35973032</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>November 7, 2022</results_first_submitted>
  <results_first_submitted_qc>January 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2023</results_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>depressive disorder, major</keyword>
  <keyword>cognitive therapy</keyword>
  <keyword>self-care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We may share de-identified data with other researchers after the completion of the study; no specific plans for this have been made yet.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Mid-2022 through 2023</ipd_time_frame>
    <ipd_access_criteria>Permission of Principal Investigator</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT02997865/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 24, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT02997865/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Between February 2017 and January 2021, patients who had a clinical diagnosis of NYHA Class I-III heart failure and who received medical care at Washington University Medical Center in St. Louis were screened for study eligibility. Those who were younger than 25 years of age or who were too ill or cognitively impaired to participate were excluded. Eligible patients who provided written informed consent were enrolled.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Stepped Care for Depression</title>
          <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
        </group>
        <group group_id="P2">
          <title>Enhanced Usual Care</title>
          <description>Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56">Number of participants who completed the Week 32 outcome assessments.</participants>
                <participants group_id="P2" count="66">Number of participants who completed the Week 32 outcome assessments.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Stepped Care for Depression</title>
          <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
        </group>
        <group group_id="B2">
          <title>Enhanced Usual Care</title>
          <description>Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</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="69"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="139"/>
          </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="58.0" spread="11.5"/>
                    <measurement group_id="B2" value="58.3" spread="12.2"/>
                    <measurement group_id="B3" value="58.2" spread="11.8"/>
                  </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="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="71"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="136"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="34"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                  </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>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education (12 years or less)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Income ($30,000/year or less)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Married or partnered</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left ventricular ejection fraction &lt;45%</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) class</title>
          <description>NYHA class indicates the functional or symptomatic severity of heart failure. Class I indicates asymptomatic (i.e., best class), class IV indicates severe heart failure (patient is unable to engage in normal physical activities), and classes II and II represent intermediate levels of functional impairment or symptom severity. Lower NYHA ratings represent better functioning or milder symptoms. Participants were classified at baseline as NYHA class I-II vs. class III-IV. The table values refer to the number and column percentage of patients in class I-II.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antidepressant medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Health Questionnaire (PHQ-9)</title>
          <description>The Patient Health Questionnaire (PHQ-9) is a 9-item patient self-report questionnaire that assesses the presence and severity of major depression. Each item represents one of the Diagnostic and Statistical Manual (DSM-5) symptoms of major depression. The item ratings range in symptom frequency from 0 (absent) to 3 (nearly every day). Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Total scores on the PHQ-9 can range from 0 to 27. Lower PHQ-9 scores represent better outcomes.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.9" spread="4.7"/>
                    <measurement group_id="B2" value="16.2" spread="5.3"/>
                    <measurement group_id="B3" value="16.5" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Beck Depression Inventory (BDI-2)</title>
          <description>The Beck Depression Inventory (BDI-2) is a 21-item patient self-report measure of the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is zero and the maximum total score is 63. A total score of 0-13 is considered nondepressed, 14-19 represents mild depression, 20-28 represents moderate depression, and 29-63 represents severe depression. Lower scores represent better outcomes.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.6" spread="8.3"/>
                    <measurement group_id="B2" value="32.1" spread="9.2"/>
                    <measurement group_id="B3" value="32.3" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hamilton Rating Scale for Depression (HAM-D-17)</title>
          <description>The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item interviewer-rated measure of the severity of depression. The total score is created by summing the item ratings. Total scores can range from zero to 52. Scores of 0-7 are considered to be in the nondepressed range, 8-16 indicate mild depression, 17-23 indicate moderate depression, and scores over 24 indicate severe depression. Lower scores represent better outcomes.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.5" spread="5.6"/>
                    <measurement group_id="B2" value="22.6" spread="5.4"/>
                    <measurement group_id="B3" value="22.6" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Care of Heart Failure Index: Maintenance</title>
          <description>The 10-item Self-Care of Heart Failure (SCHFI v6.2) Maintenance scale assesses the frequency of engagement in heart failure-related health behaviors. The total score is standardized and can range from 0 (worst) to 100 (best). Adequate self-care maintenance behavior is defined as a score of 70 or higher</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.7" spread="15.7"/>
                    <measurement group_id="B2" value="55.5" spread="16.2"/>
                    <measurement group_id="B3" value="58.1" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Care of Heart Failure Index: Management</title>
          <description>The 6-item Self-Care of Heart Failure (SCHFI v6.2) Management scale assesses the patient's responses to signs or symptoms of acute or worsening heart failure. The total score is standardized and can range from 0 (worst) to 100 (best). Adequate self-care management behavior is defined as a score of 70 or higher.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.7" spread="22.2"/>
                    <measurement group_id="B2" value="52.4" spread="22.6"/>
                    <measurement group_id="B3" value="52.4" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Care of Heart Failure Index: Confidence</title>
          <description>The 6-item Self-Care of Heart Failure (SCHFI v6.2) Confidence scale assesses the patient's confidence in his/her ability to manage the signs and symptoms of heart failure. The total score is standardized and can range from 0 (worst) to 100 (best). Adequate self-care confidence behavior is defined as a score of 70 or higher.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.8" spread="23.7"/>
                    <measurement group_id="B2" value="51.0" spread="23.3"/>
                    <measurement group_id="B3" value="54.8" spread="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Beck Anxiety Inventory (BAI)</title>
          <description>The Beck Anxiety Inventory (BAI) is a 21-item patient-self report questionnaire about symptoms of anxiety. Each symptom is rated on a four-point scale ranging from 0 (not at all) to 3 (severe - it bothered me a lot). Total scores can range from 0 (best) to 63 (worst). Scores of 0-21 indicate little or no anxiety, 22-35 moderate anxiety, and 36-63 severe anxiety.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.2" spread="12.3"/>
                    <measurement group_id="B2" value="22.1" spread="13.2"/>
                    <measurement group_id="B3" value="22.7" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kansas City Cardiomyopathy Questionnaire (KCCQ)</title>
          <description>The 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score is scaled to range from 0 (worst) to 100 (best) heart-failure-related quality of life. Scores of 0 to 24 represent very poor to poor qualify to life; 25 to 49 poor to fair quality of life; 50 to 74 fair to good quality of life; and 75 to 100 good to excellent quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.9" spread="22.0"/>
                    <measurement group_id="B2" value="46.5" spread="18.9"/>
                    <measurement group_id="B3" value="46.2" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Beck Depression Inventory (BDI-2) Total Score</title>
        <description>The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stepped Care for Depression</title>
            <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory (BDI-2) Total Score</title>
          <description>The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression.</description>
          <units>score 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="69"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="9.7"/>
                    <measurement group_id="O2" value="19.6" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self Care of Heart Failure Index (SCHFI) Maintenance Subscale</title>
        <description>The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stepped Care for Depression</title>
            <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Self Care of Heart Failure Index (SCHFI) Maintenance Subscale</title>
          <description>The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care.</description>
          <units>score 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="69"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4" spread="12.5"/>
                    <measurement group_id="O2" value="73.0" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory</title>
        <description>The BAI measures the self-reported severity of anxiety symptoms. Total BAI scores range from 0 (best) to 63 (worst). A total score of 0-7 is considered nonanxious; scores between 8-15 are consistent with mild, 16-25 moderate, and 26-63 severe anxiety.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stepped Care for Depression</title>
            <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory</title>
          <description>The BAI measures the self-reported severity of anxiety symptoms. Total BAI scores range from 0 (best) to 63 (worst). A total score of 0-7 is considered nonanxious; scores between 8-15 are consistent with mild, 16-25 moderate, and 26-63 severe anxiety.</description>
          <units>score 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="69"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="9.3"/>
                    <measurement group_id="O2" value="15.1" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kansas City Cardiomyopathy Questionnaire (KCCQ)</title>
        <description>The KCCQ assesses the patient's self-reported, heart failure-related functioning and quality of life. Scores range from 0 (worst) to 100 (best). Scores between 0-24 are consistent with very poor to poor health status, 25-49 poor to fair health status, 50-74 fair to good health status, and 75-100 good to excellent health status.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stepped Care for Depression</title>
            <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Kansas City Cardiomyopathy Questionnaire (KCCQ)</title>
          <description>The KCCQ assesses the patient's self-reported, heart failure-related functioning and quality of life. Scores range from 0 (worst) to 100 (best). Scores between 0-24 are consistent with very poor to poor health status, 25-49 poor to fair health status, 50-74 fair to good health status, and 75-100 good to excellent health status.</description>
          <units>score 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="69"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.7" spread="16.9"/>
                    <measurement group_id="O2" value="61.2" spread="57.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hamilton Rating Scale for Depression (HAM-D-17)</title>
        <description>The Hamilton Rating Scale total score indicates the interviewer-rated severity of depression symptoms. Total scores can range from 0 to 52, with higher scores indicating worse depression. Patients who score 0-9 are considered to be nondepressed. Scores of 10-13 represent mild, 14-17 mild to moderate, and &gt;17 moderate to severe depression.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stepped Care for Depression</title>
            <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Hamilton Rating Scale for Depression (HAM-D-17)</title>
          <description>The Hamilton Rating Scale total score indicates the interviewer-rated severity of depression symptoms. Total scores can range from 0 to 52, with higher scores indicating worse depression. Patients who score 0-9 are considered to be nondepressed. Scores of 10-13 represent mild, 14-17 mild to moderate, and &gt;17 moderate to severe depression.</description>
          <units>score 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="69"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="5.7"/>
                    <measurement group_id="O2" value="15.0" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Actigraphy</title>
        <description>Actigraphy was used to track the patient's physical activity level. However, actigraphy had to be discontinued during the first few months of the trial due to the COVID-19 pandemic.</description>
        <time_frame>16 weeks</time_frame>
        <population>Although we planned to collect actigraphy data at baseline and 16 weeks and report the 16-week data as an outcome, we were unable to collect actigraphy data due to the coronavirus (COVID-19) pandemic.</population>
        <group_list>
          <group group_id="O1">
            <title>Stepped Care for Depression</title>
            <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Participants will receive individually-tailored heart failure self-care education and support. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Actigraphy</title>
          <description>Actigraphy was used to track the patient's physical activity level. However, actigraphy had to be discontinued during the first few months of the trial due to the COVID-19 pandemic.</description>
          <population>Although we planned to collect actigraphy data at baseline and 16 weeks and report the 16-week data as an outcome, we were unable to collect actigraphy data due to the coronavirus (COVID-19) pandemic.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>32 weeks</time_frame>
      <desc>All-cause mortality. Obtained from hospitalization records, informant interviews, online records, or other sources.</desc>
      <group_list>
        <group group_id="E1">
          <title>Stepped Care for Depression</title>
          <description>Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.&#xD;
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.</description>
        </group>
        <group group_id="E2">
          <title>Enhanced Usual Care</title>
          <description>Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </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="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </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>
    <limitations_and_caveats>This was a single-center trial. Fewer patients were enrolled than planned, primarily due to recruitment challenges during the COVID-19 pandemic. Actigraphy data could not be collected due to the pandemic.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kenneth E. Freedland, PhD</name_or_title>
      <organization>Washington University School of Medicine in St. Louis</organization>
      <phone>314-286-1311</phone>
      <email>freedlak@wustl.edu</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/NCT02997865
org study id: R01HL131524
secondary id: R01HL131524
nct id: NCT02997865
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates stepped care for depression in patients with heart failure (HF). The
      stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half
      of the participants will receive stepped care and half will receive usual care for
      depression; all participants will receive heart failure self-care education and support. The
      primary aims are to determine whether stepped care is superior to usual care for depression,
      and whether treating depression improves heart failure self-care outcomes.
Depression is associated with poor heart failure self-care. Good self-care practices,
      including following dietary recommendations, taking prescribed medications, monitoring
      symptoms, and regular light exercise have been shown to improve quality of life and survival
      in persons with heart failure.

      Both CBT and antidepressant medications have been used in previous studies to treat major
      depression in patients with heart failure. Participants in the intervention arm in this trial
      will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT
      may also be referred to their own physician to discuss antidepressant medications.

      Heart failure self-care education and support will be provided after the first 8 weeks of the
      depression intervention. The study will determine whether people with heart failure benefit
      more from self-care education and support after their depression has been treated with a
      stepped care intervention, as compared to usual care for depression as provided by primary
      care providers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Beck Depression Inventory (BDI-2) Total Score
time frame: 16 weeks
description: The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression.
measure: Self Care of Heart Failure Index (SCHFI) Maintenance Subscale
time frame: 16 weeks
description: The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care.
measure: Beck Anxiety Inventory
time frame: 16 weeks
description: The BAI measures the self-reported severity of anxiety symptoms. Total BAI scores range from 0 (best) to 63 (worst). A total score of 0-7 is considered nonanxious; scores between 8-15 are consistent with mild, 16-25 moderate, and 26-63 severe anxiety.
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: 16 weeks
description: The KCCQ assesses the patient's self-reported, heart failure-related functioning and quality of life. Scores range from 0 (worst) to 100 (best). Scores between 0-24 are consistent with very poor to poor health status, 25-49 poor to fair health status, 50-74 fair to good health status, and 75-100 good to excellent health status.
measure: Hamilton Rating Scale for Depression (HAM-D-17)
time frame: 16 weeks
description: The Hamilton Rating Scale total score indicates the interviewer-rated severity of depression symptoms. Total scores can range from 0 to 52, with higher scores indicating worse depression. Patients who score 0-9 are considered to be nondepressed. Scores of 10-13 represent mild, 14-17 mild to moderate, and >17 moderate to severe depression.
measure: Actigraphy
time frame: 16 weeks
description: Actigraphy was used to track the patient's physical activity level. However, actigraphy had to be discontinued during the first few months of the trial due to the COVID-19 pandemic.
arm group label: Stepped Care for Depression
arm group type: Experimental
description: Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support.
arm group label: Enhanced Usual Care
arm group type: No Intervention
description: Participants will receive individually-tailored heart failure self-care education and support. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician.
intervention type: Behavioral
intervention name: Stepped care for depression
description: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.
arm group label: Stepped Care for Depression
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth E Freedland, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
citation: Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rubin EH, Rich MW. Sequential Interventions for Major Depression and Heart Failure Self-Care: A Randomized Clinical Trial. Circ Heart Fail. 2022 Aug;15(8):e009422. doi: 10.1161/CIRCHEARTFAILURE.121.009422. Epub 2022 Jun 21.
PMID: 35973032
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: Yes
ipd description: We may share de-identified data with other researchers after the completion of the study; no specific plans for this have been made yet.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Mid-2022 through 2023
ipd access criteria: Permission of Principal Investigator
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This was a single-center trial. Fewer patients were enrolled than planned, primarily due to recruitment challenges during the COVID-19 pandemic. Actigraphy data could not be collected due to the pandemic.
point of contact: 