<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/NCT04441086</url>
  </required_header>
  <id_info>
    <org_study_id>2002325890</org_study_id>
    <nct_id>NCT04441086</nct_id>
  </id_info>
  <brief_title>Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction</brief_title>
  <acronym>eMotion</acronym>
  <official_title>Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sigma Theta Tau International Honor Society of Nursing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jonas Philanthropies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</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>
      The purpose of this study is to evaluate early preliminary efficacy of the eMotion&#xD;
      intervention in US adults who have experienced a first cardiac event and participating in&#xD;
      phase II cardiac rehabilitation.&#xD;
&#xD;
      This study will evaluate early efficacy and evaluate the cognitive processes as intervention&#xD;
      response variables. Investigators will also examine the relationships between emotion&#xD;
      regulation and other cognitive processes and symptoms (threat and stress, cognition and&#xD;
      motivation), symptoms [depression, anxiety, pain, sleep, and fatigue]), and health related&#xD;
      quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: Evaluate early preliminary efficacy of the eMotion intervention&#xD;
&#xD;
      Research hypothesis 1. Compared with adults randomized to active healthy living attention&#xD;
      control and usual care control groups, adults randomized to eMotion will have greater&#xD;
      improvement in these outcomes over time:&#xD;
&#xD;
      1.1. Improved minutes of moderate to vigorous physical activity 1.2. Symptom improvement&#xD;
      (depression, anxiety, pain, sleep, and fatigue) 1.3. Health related quality of life.&#xD;
&#xD;
      Aim 2: Evaluate the cognitive processes as intervention response variables.&#xD;
&#xD;
      Research hypothesis 2. Compared with adults randomized to active healthy living attention&#xD;
      control and usual care control groups, adults randomized to eMotion will have:&#xD;
&#xD;
      2.1. Improved emotion regulation (efficiency and strategy use) 2.2. Decreased perceived&#xD;
      cardiac threat and general stress 2.3. Improved cognition and motivation&#xD;
&#xD;
      Aim 3. Exploratory. Examine the relationships between emotion regulation and other cognitive&#xD;
      processes and symptoms (threat and stress, cognition and motivation), and symptoms&#xD;
      [depression, anxiety, pain, sleep, and fatigue]) among adults enrolled in cardiac&#xD;
      rehabilitation after a first major cardiac event.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 12, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Moderate to Vigorous Physical Activity (MVPA)</measure>
    <time_frame>1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks</time_frame>
    <description>Minutes spent in MVPA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Depression Symptoms</measure>
    <time_frame>Baseline to 12 weeks, 20 weeks, and 52 weeks</time_frame>
    <description>Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety Symptoms</measure>
    <time_frame>Baseline to 12 weeks, 20 weeks, and 52 weeks</time_frame>
    <description>Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Symptoms</measure>
    <time_frame>Baseline to 12 weeks, 20 weeks, and 52 weeks</time_frame>
    <description>Pain will be measured with the Brief Pain Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep efficiency</measure>
    <time_frame>Baseline to 12 weeks, 20 weeks, and 52 weeks</time_frame>
    <description>Sleep efficiency will be a calculation of the ratio of the total sleep time to time spent in bed using the ActiGraph wGT3X-BT accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue Symptoms</measure>
    <time_frame>Baseline to 12 weeks, 20 weeks, and 52 weeks</time_frame>
    <description>Fatigue will be measured using the Fatigue Severity Scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cardiac Event</condition>
  <condition>Emotions</condition>
  <arm_group>
    <arm_group_label>eMotion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The eMotion intervention is based on feasibility testing of the successful in-person program with critical refinement to improve accessibility. eMotion has undergone subsequent content validity testing with intervention development, self-management, cardiovascular health, and health information technology delivery experts. eMotion teaches a carefully selected repertoire of emotion regulation strategies well suited for aging rural adults following a first cardiac event in tandem with usual cardiac rehabilitation. The intervention helps patients recognize their emotions, balance emotional and physical wellbeing, and implement emotion regulation strategies effectively. Intervention provided in addition to usual cardiac rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy living active control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual cardiac rehabilitation with no additional intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eMotion</intervention_name>
    <description>Content is delivered within the context of emotion provoking situations common in those recovering from a first MI and in maintaining MVPA. The new on-demand access to asynchronous content sessions provides didactic presentation of video and written material based on weekly needs assessments. Weekly scheduled synchronous video chat sessions, led by a nurse interventionist, will provide further individualization and application of content materials.</description>
    <arm_group_label>eMotion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Living Active Control</intervention_name>
    <description>The attention control group will receive their usual cardiac rehabilitation and a comparable dose matched (to that of the eMotion intervention) of healthy living web content and video chat with a nurse.</description>
    <arm_group_label>Healthy living active control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. First time major cardiac event as documented in medical record;&#xD;
&#xD;
          2. enrolled in cardiac rehabilitation phase II program;&#xD;
&#xD;
          3. living independently; and&#xD;
&#xD;
          4. at least mild symptoms of depression and/or anxiety (determined by standardized&#xD;
             measure cutpoints).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. does not speak English;&#xD;
&#xD;
          2. major Axis 1 psychiatric diagnosis (e.g. schizophrenia);&#xD;
&#xD;
          3. terminal cancer; and&#xD;
&#xD;
          4. legally blind&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly L Wierenga, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Health West Hospital</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Bedford Hospital</name>
      <address>
        <city>Bedford</city>
        <state>Indiana</state>
        <zip>47421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Tipton Hospital</name>
      <address>
        <city>Tipton</city>
        <state>Indiana</state>
        <zip>46072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Kelly L. Wierenga</investigator_full_name>
    <investigator_title>Assistant Professor, Nursing</investigator_title>
  </responsible_party>
  <keyword>Emotion regulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Infarction</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/NCT04441086
org study id: 2002325890
nct id: NCT04441086
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate early preliminary efficacy of the eMotion
      intervention in US adults who have experienced a first cardiac event and participating in
      phase II cardiac rehabilitation.

      This study will evaluate early efficacy and evaluate the cognitive processes as intervention
      response variables. Investigators will also examine the relationships between emotion
      regulation and other cognitive processes and symptoms (threat and stress, cognition and
      motivation), symptoms [depression, anxiety, pain, sleep, and fatigue]), and health related
      quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event.
Aim 1: Evaluate early preliminary efficacy of the eMotion intervention

      Research hypothesis 1. Compared with adults randomized to active healthy living attention
      control and usual care control groups, adults randomized to eMotion will have greater
      improvement in these outcomes over time:

      1.1. Improved minutes of moderate to vigorous physical activity 1.2. Symptom improvement
      (depression, anxiety, pain, sleep, and fatigue) 1.3. Health related quality of life.

      Aim 2: Evaluate the cognitive processes as intervention response variables.

      Research hypothesis 2. Compared with adults randomized to active healthy living attention
      control and usual care control groups, adults randomized to eMotion will have:

      2.1. Improved emotion regulation (efficiency and strategy use) 2.2. Decreased perceived
      cardiac threat and general stress 2.3. Improved cognition and motivation

      Aim 3. Exploratory. Examine the relationships between emotion regulation and other cognitive
      processes and symptoms (threat and stress, cognition and motivation), and symptoms
      [depression, anxiety, pain, sleep, and fatigue]) among adults enrolled in cardiac
      rehabilitation after a first major cardiac event.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change in Moderate to Vigorous Physical Activity (MVPA)
time frame: 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks
description: Minutes spent in MVPA
measure: Change in Depression Symptoms
time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
description: Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)
measure: Change in Anxiety Symptoms
time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
description: Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)
measure: Change in Pain Symptoms
time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
description: Pain will be measured with the Brief Pain Inventory
measure: Change in Sleep efficiency
time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
description: Sleep efficiency will be a calculation of the ratio of the total sleep time to time spent in bed using the ActiGraph wGT3X-BT accelerometer
measure: Change in Fatigue Symptoms
time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
description: Fatigue will be measured using the Fatigue Severity Scale
arm group label: eMotion
arm group type: Experimental
description: The eMotion intervention is based on feasibility testing of the successful in-person program with critical refinement to improve accessibility. eMotion has undergone subsequent content validity testing with intervention development, self-management, cardiovascular health, and health information technology delivery experts. eMotion teaches a carefully selected repertoire of emotion regulation strategies well suited for aging rural adults following a first cardiac event in tandem with usual cardiac rehabilitation. The intervention helps patients recognize their emotions, balance emotional and physical wellbeing, and implement emotion regulation strategies effectively. Intervention provided in addition to usual cardiac rehabilitation.
arm group label: Healthy living active control
arm group type: Active Comparator
description: Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation.
arm group label: Usual care
arm group type: No Intervention
description: Usual cardiac rehabilitation with no additional intervention.
intervention type: Behavioral
intervention name: eMotion
description: Content is delivered within the context of emotion provoking situations common in those recovering from a first MI and in maintaining MVPA. The new on-demand access to asynchronous content sessions provides didactic presentation of video and written material based on weekly needs assessments. Weekly scheduled synchronous video chat sessions, led by a nurse interventionist, will provide further individualization and application of content materials.
arm group label: eMotion
intervention type: Behavioral
intervention name: Healthy Living Active Control
description: The attention control group will receive their usual cardiac rehabilitation and a comparable dose matched (to that of the eMotion intervention) of healthy living web content and video chat with a nurse.
arm group label: Healthy living active control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kelly L Wierenga, PhD
role: Principal Investigator
affiliation: Indiana University School of Medicine
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Kelly L. Wierenga
investigator title: Assistant Professor, Nursing
mesh term: Myocardial Infarction
mesh term: Cardiovascular Diseases
mesh term: Infarction