<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/NCT03013907</url>
  </required_header>
  <id_info>
    <org_study_id>16-01350</org_study_id>
    <nct_id>NCT03013907</nct_id>
  </id_info>
  <brief_title>Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension (EASE) Study</brief_title>
  <official_title>Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension (EASE) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      The purpose of this study is to adapt and then evaluate the feasibility, acceptability, and&#xD;
      efficacy of a telephone-based intervention (UPLIFT: Using Practice and Learning to Increase&#xD;
      Favorable Thoughts) for individuals with elevated depressive symptoms and hypertension.&#xD;
      UPLIFT is a group-based intervention that is delivered over 8 weekly sessions for 1 hour/week&#xD;
      by phone.&#xD;
&#xD;
      Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual&#xD;
      interviews and to test the adapted UPLIFT program in a single-arm design. Aim 2 of this study&#xD;
      is a randomized controlled trial (RCT) that will compare the effects of the adapted UPLIFT&#xD;
      program to usual care (UC) and to test mediators and moderators of the effects of UPLIFT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once 16 participants are enrolled (to form 2 groups of 8 patients each), an independent study&#xD;
      staff member will determine participants' group assignments. The randomization sequence will&#xD;
      be created a priori by Dr. Keith Goldfeld (biostatistician) by using a computer-generated&#xD;
      list of random numbers with stratification by antidepressant medication use and baseline&#xD;
      levels of depressive symptoms (PHQ scores &lt;10 and ≥10).&#xD;
&#xD;
      UPLIFT: Eligible participants will complete 8 weekly group sessions by phone. The&#xD;
      intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive&#xD;
      symptoms. Each hour-long weekly session consists of: check-in, instruction, skill building,&#xD;
      discussion, and a home-based practice assignment.&#xD;
&#xD;
      Usual care: Subjects randomized to UC will be advised to seek help from their primary care&#xD;
      physician (PCP) or other sources as they normally would if they encountered symptomatic&#xD;
      deterioration or other difficulties over the course of the study. All treatments received&#xD;
      over the course of the study for the UC group and outside of the study (for the intervention&#xD;
      group) will be assessed at each time point.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">October 12, 2018</completion_date>
  <primary_completion_date type="Actual">October 12, 2018</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility measured by the number of weekly sessions attended</measure>
    <time_frame>6 Months</time_frame>
    <description>Determined by the number of weekly sessions attended and number of days of home-based practice completed each week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>6 Months</time_frame>
    <description>8-item Client Satisfaction Questionnaire (CSQ-8)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PHQ-9</measure>
    <time_frame>6 Months</time_frame>
    <description>validated measure of depressive symptoms. Items rate symptom severity during the prior 2 weeks based on DSM-IV diagnostic criteria for major depression. Scores range from 0-27; scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 will be completed at screening and at all study visits (continuous scores).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quick Inventory of Depressive Symptomatology (QIDS-SR 16)</measure>
    <time_frame>6 Months</time_frame>
    <description>Standardized depression instrument that has treatment sensitivity advantages over the PHQ-9 and will be administered at pre- and post-treatment. Total scores on the QIDS-SR16 range from 0 to 27 and reflect depression severity across 9 domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>UPLIFT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will complete 8 weekly group sessions by phone. The intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive symptoms. Each hour-long weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to UC will be advised to seek help from their primary care physician (PCP) or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study. All treatments received over the course of the study for the UC group and outside of the study (for the intervention group) will be assessed at each time point.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>UPLIFT</intervention_name>
    <description>Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping &amp; Relaxing Session 4: Attention &amp; Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure &amp; the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks</description>
    <arm_group_label>UPLIFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Subjects randomized to UC will be advised to seek help from their primary care physician (PCP) or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of hypertension based on the criteria in the ICD-9/-10&#xD;
&#xD;
          -  Mild to moderate depressive symptoms (PHQ-9 ≥ 5)&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  If taking depression medications, medications must stable for the past 6 weeks (no&#xD;
             change to type or dose)&#xD;
&#xD;
          -  Willing to provide informed consent, be audio-recorded, and comply with all other&#xD;
             aspects of protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe depressive symptoms (PHQ-9 ≥ 15)&#xD;
&#xD;
          -  Current substance abuse&#xD;
&#xD;
          -  Current eating disorder&#xD;
&#xD;
          -  Self-harm within the past 3 months&#xD;
&#xD;
          -  Current obsessive-compulsive disorder&#xD;
&#xD;
          -  Current anxiety disorder (e.g., PTSD, panic disorder)&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
&#xD;
          -  History of or current diagnosis of psychosis&#xD;
&#xD;
          -  Significant cognitive impairment (mini mental state examination score ≤ 20)&#xD;
&#xD;
          -  History of previous training in mindfulness&#xD;
&#xD;
          -  History of more than 8 sessions of cognitive behavioral therapy&#xD;
&#xD;
          -  Counseling more frequently than once per month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda Shallcross, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>November 12, 2019</last_update_submitted>
  <last_update_submitted_qc>November 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Coping</keyword>
  <keyword>Relaxing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT03013907
org study id: 16-01350
nct id: NCT03013907
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to adapt and then evaluate the feasibility, acceptability, and
      efficacy of a telephone-based intervention (UPLIFT: Using Practice and Learning to Increase
      Favorable Thoughts) for individuals with elevated depressive symptoms and hypertension.
      UPLIFT is a group-based intervention that is delivered over 8 weekly sessions for 1 hour/week
      by phone.

      Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual
      interviews and to test the adapted UPLIFT program in a single-arm design. Aim 2 of this study
      is a randomized controlled trial (RCT) that will compare the effects of the adapted UPLIFT
      program to usual care (UC) and to test mediators and moderators of the effects of UPLIFT.
Once 16 participants are enrolled (to form 2 groups of 8 patients each), an independent study
      staff member will determine participants' group assignments. The randomization sequence will
      be created a priori by Dr. Keith Goldfeld (biostatistician) by using a computer-generated
      list of random numbers with stratification by antidepressant medication use and baseline
      levels of depressive symptoms (PHQ scores <10 and ≥10).

      UPLIFT: Eligible participants will complete 8 weekly group sessions by phone. The
      intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive
      symptoms. Each hour-long weekly session consists of: check-in, instruction, skill building,
      discussion, and a home-based practice assignment.

      Usual care: Subjects randomized to UC will be advised to seek help from their primary care
      physician (PCP) or other sources as they normally would if they encountered symptomatic
      deterioration or other difficulties over the course of the study. All treatments received
      over the course of the study for the UC group and outside of the study (for the intervention
      group) will be assessed at each time point.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Feasibility measured by the number of weekly sessions attended
time frame: 6 Months
description: Determined by the number of weekly sessions attended and number of days of home-based practice completed each week
measure: Acceptability
time frame: 6 Months
description: 8-item Client Satisfaction Questionnaire (CSQ-8)
measure: PHQ-9
time frame: 6 Months
description: validated measure of depressive symptoms. Items rate symptom severity during the prior 2 weeks based on DSM-IV diagnostic criteria for major depression. Scores range from 0-27; scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 will be completed at screening and at all study visits (continuous scores).
measure: Quick Inventory of Depressive Symptomatology (QIDS-SR 16)
time frame: 6 Months
description: Standardized depression instrument that has treatment sensitivity advantages over the PHQ-9 and will be administered at pre- and post-treatment. Total scores on the QIDS-SR16 range from 0 to 27 and reflect depression severity across 9 domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.
arm group label: UPLIFT
arm group type: Experimental
description: Eligible participants will complete 8 weekly group sessions by phone. The intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive symptoms. Each hour-long weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.
arm group label: Usual Care
arm group type: Active Comparator
description: Subjects randomized to UC will be advised to seek help from their primary care physician (PCP) or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study. All treatments received over the course of the study for the UC group and outside of the study (for the intervention group) will be assessed at each time point.
intervention type: Behavioral
intervention name: UPLIFT
description: Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping & Relaxing Session 4: Attention & Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure & the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks
arm group label: UPLIFT
intervention type: Behavioral
intervention name: Usual care
description: Subjects randomized to UC will be advised to seek help from their primary care physician (PCP) or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study
arm group label: Usual Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Amanda Shallcross, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension