<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/NCT03303703</url>
  </required_header>
  <id_info>
    <org_study_id>ANF6098</org_study_id>
    <nct_id>NCT03303703</nct_id>
  </id_info>
  <brief_title>Partnering Physical and Emotional Fitness: Improving Cardiac Recovery With Training in Emotion Regulation</brief_title>
  <official_title>Partnering Physical and Emotional Fitness: Improving Cardiac Recovery With Training in Emotion Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Western Reserve University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who have just experienced a first major cardiac event are at risk of experiencing&#xD;
      heightened negative emotions, which further negatively impact self-management of health&#xD;
      behaviors. For those patients in phase II cardiac rehabilitation, there is an opportunity to&#xD;
      address physical and emotional wellbeing to optimize self-management of diet and exercise.&#xD;
      This study will pilot test an intervention aimed at improving these patients' abilities to&#xD;
      regulate their emotions as a mechanism to minimize psychological distress and improve&#xD;
      self-management of diet and exercise, as well as improve quality of life. This innovative&#xD;
      pilot will generate knowledge about the impact of emotion regulation in first event cardiac&#xD;
      rehabilitation patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Significance. For the over 900,000 Americans experiencing a first cardiac event annually,&#xD;
      stress, depression, and anxiety complicate recovery. Emotional distress, such as depression,&#xD;
      anxiety, and rumination, detracts from a patient's ability to self-manage health behaviors&#xD;
      such as diet and exercise. Those patients engaged in cardiac rehabilitation (CR) programs are&#xD;
      in a unique position to enhance their recovery, yet do not regularly receive training to&#xD;
      regulate their emotions. Effective emotion regulation can diminish symptoms of emotional&#xD;
      distress. Developing an effective repertoire of emotion regulation strategies may be an&#xD;
      important mechanism to strengthen self-management behaviors and quality of life. By&#xD;
      understanding the neuroscience behind the mechanism of emotion regulation, targeted&#xD;
      intervention strategies may aid in improving self-management behaviors. The newly developed&#xD;
      RENEwS (Regulating Emotions to improve self-management of Nutrition, Exercise, and Stress)&#xD;
      intervention is specifically designed to improve emotion regulation in CR patients and&#xD;
      targets strengthening the recently discovered neural network task differentiation (analytic&#xD;
      and emotional processing). RENEwS focuses on teaching emotion regulation strategies relevant&#xD;
      to older adults following a first cardiac health event.&#xD;
&#xD;
      Purpose. The goals of this pilot study are to assess the initial effects of the RENEwS&#xD;
      program on 1) negative emotions, 2) self-management behaviors of diet and exercise, and 3)&#xD;
      quality of life in CR patients following an acute cardiac event. A secondary goal of the&#xD;
      proposed research is to explore the neurological (using fMRI) and psychological (emotion&#xD;
      regulation) mechanisms through which the RENEwS intervention reduces negative emotions,&#xD;
      increases healthy diet and exercise, and increases quality of life. Study aims are:&#xD;
&#xD;
      Aim 1: Determine feasibility, acceptability, and effect size of the RENEwS intervention.&#xD;
&#xD;
      Aim 2: Determine the effect of the RENEwS program on negative emotions (depressive symptoms,&#xD;
      anxiety, and rumination), self-management behaviors (diet and exercise), and quality of life&#xD;
      as compared to an attention control group.&#xD;
&#xD;
      Aim 3a: Examine the relationships between emotion regulation and 1) selected psychological&#xD;
      factors (patient activation, self-efficacy, decision-making, and attention), 2) neural&#xD;
      processing (brain activation/function and task switching), and 3) perceived stress.&#xD;
&#xD;
      Aim 3b: Examine the possible mediating effect of emotion regulation, psychological factors,&#xD;
      neural processing, and stress on the effectiveness of the RENEwS intervention to reduce&#xD;
      negative emotions, and to improve self-management behaviors and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Quality of life will be assessed with the 29-item Perceived Health Status (PROMIS-29). This measure examines quality of life across chronic illness populations. Total score of the PROMIS-29 will be used in the analysis of quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Psychological symptoms- Depression</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Depression will be measured with the 16 item Quick Inventory of Depressive Symptomatology and PROMIS depression-4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychological symptoms- Anxiety</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Anxiety will be assessed using the 7 anxiety items from the short-form of the Depression Anxiety Stress Scale and the PROMIS anxiety-4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychological symptoms- Rumination</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Rumination will be measured with the 22-item Ruminative Responses Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-management behaviors- Diet</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Diet will be assessed with the Nutrient Data Systems Report is a 24-item recall delivered by a trained nutritionist. This recall provides detailed intake information about over 150 different nutrients as well as food groups.39 Analysis of aims will use total intake of sodium and lipids.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-management behaviors- Exercise</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Exercise will be assessed with actigraphy. Intensity and number of minutes of exercise will be assessed over a three-day period using the Actigraph Active Living Protocol. Total number of minutes and number of minutes in moderate to high intensity of exercise will be used for analysis of study aims.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Emotion regulation</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Emotion regulation will be measured with the 16-item Emotional Regulation Profile-Revised.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stress</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Stress will be measured with the 10-item Perceived Stress Scale(PSS). PSS items are on a 5-point Likert-type scale and include subjective statements related to stress experienced in the last 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Activation</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Patient activation will be measured with the 10-item Patient Activation Measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-efficacy</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Self-efficacy will be measured with the 6-item Self Efficacy for Managing Chronic Disease scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Neural Function Brain Activation</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Brain activation will be assessed using functional Magnetic Resonance Imaging (fMRI). Neural network differentiation will be assessed using passive viewing of video clips, each 23 seconds in length. Half of the video clips will assess analytic thinking, and half empathetic/emotional cognition. Brain activity associated with each of these conditions will be assessed relative to a resting baseline, achieved by including fixation conditions of the same length and frequency as the video stimuli. All stimuli are presented with EPrime psychology software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Decision making</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Decision making will be assessed with the Iowa gambling task. This task will be conducted to assess decision making with a real-life simulation. In this task participants select decks of cards with the goal of winning as much money as possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Attention</measure>
    <time_frame>baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).</time_frame>
    <description>Attention will be measured with the 13 item Attention Function Index.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Cardiac Disease</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual cardiac rehabilitation and social phone calls for attention control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RENEwS intervention is five 60-minute group educational sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RENEwS</intervention_name>
    <description>The intervention participants will meet with a trained interventionist for five 60-minute sessions as a group (two groups of five participants each). In the sessions time will be divided between didactic presentation of material, active practicing of techniques, group work focused on case studies, and worksheets for further practice at home. Topics covered within the intervention include emotional awareness, balancing emotional and physical wellbeing, selecting and implementing emotion regulation strategies (such as situation selections, mindfulness, engagement/avoidance, reappraisal, and emotional sharing), and emotional monitoring.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of CVD&#xD;
&#xD;
          -  phase II CR initiated within the past 2 months&#xD;
&#xD;
          -  planned 12 weeks of CR&#xD;
&#xD;
          -  living independently&#xD;
&#xD;
          -  at least 40 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who do not speak English&#xD;
&#xD;
          -  have experienced cardiac arrest&#xD;
&#xD;
          -  have an implanted pacemaker or defibrillator&#xD;
&#xD;
          -  not approved safe for exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>March 20, 2020</last_update_submitted>
  <last_update_submitted_qc>March 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Kelly Wierenga</investigator_full_name>
    <investigator_title>Postdoctoral Fellow</investigator_title>
  </responsible_party>
  <keyword>cardiac rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Heart 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/NCT03303703
org study id: ANF6098
nct id: NCT03303703
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients who have just experienced a first major cardiac event are at risk of experiencing
      heightened negative emotions, which further negatively impact self-management of health
      behaviors. For those patients in phase II cardiac rehabilitation, there is an opportunity to
      address physical and emotional wellbeing to optimize self-management of diet and exercise.
      This study will pilot test an intervention aimed at improving these patients' abilities to
      regulate their emotions as a mechanism to minimize psychological distress and improve
      self-management of diet and exercise, as well as improve quality of life. This innovative
      pilot will generate knowledge about the impact of emotion regulation in first event cardiac
      rehabilitation patients.
Significance. For the over 900,000 Americans experiencing a first cardiac event annually,
      stress, depression, and anxiety complicate recovery. Emotional distress, such as depression,
      anxiety, and rumination, detracts from a patient's ability to self-manage health behaviors
      such as diet and exercise. Those patients engaged in cardiac rehabilitation (CR) programs are
      in a unique position to enhance their recovery, yet do not regularly receive training to
      regulate their emotions. Effective emotion regulation can diminish symptoms of emotional
      distress. Developing an effective repertoire of emotion regulation strategies may be an
      important mechanism to strengthen self-management behaviors and quality of life. By
      understanding the neuroscience behind the mechanism of emotion regulation, targeted
      intervention strategies may aid in improving self-management behaviors. The newly developed
      RENEwS (Regulating Emotions to improve self-management of Nutrition, Exercise, and Stress)
      intervention is specifically designed to improve emotion regulation in CR patients and
      targets strengthening the recently discovered neural network task differentiation (analytic
      and emotional processing). RENEwS focuses on teaching emotion regulation strategies relevant
      to older adults following a first cardiac health event.

      Purpose. The goals of this pilot study are to assess the initial effects of the RENEwS
      program on 1) negative emotions, 2) self-management behaviors of diet and exercise, and 3)
      quality of life in CR patients following an acute cardiac event. A secondary goal of the
      proposed research is to explore the neurological (using fMRI) and psychological (emotion
      regulation) mechanisms through which the RENEwS intervention reduces negative emotions,
      increases healthy diet and exercise, and increases quality of life. Study aims are:

      Aim 1: Determine feasibility, acceptability, and effect size of the RENEwS intervention.

      Aim 2: Determine the effect of the RENEwS program on negative emotions (depressive symptoms,
      anxiety, and rumination), self-management behaviors (diet and exercise), and quality of life
      as compared to an attention control group.

      Aim 3a: Examine the relationships between emotion regulation and 1) selected psychological
      factors (patient activation, self-efficacy, decision-making, and attention), 2) neural
      processing (brain activation/function and task switching), and 3) perceived stress.

      Aim 3b: Examine the possible mediating effect of emotion regulation, psychological factors,
      neural processing, and stress on the effectiveness of the RENEwS intervention to reduce
      negative emotions, and to improve self-management behaviors and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Change in Quality of life
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Quality of life will be assessed with the 29-item Perceived Health Status (PROMIS-29). This measure examines quality of life across chronic illness populations. Total score of the PROMIS-29 will be used in the analysis of quality of life.
measure: Change in Psychological symptoms- Depression
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Depression will be measured with the 16 item Quick Inventory of Depressive Symptomatology and PROMIS depression-4.
measure: Change in Psychological symptoms- Anxiety
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Anxiety will be assessed using the 7 anxiety items from the short-form of the Depression Anxiety Stress Scale and the PROMIS anxiety-4.
measure: Change in Psychological symptoms- Rumination
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Rumination will be measured with the 22-item Ruminative Responses Scale.
measure: Change in Self-management behaviors- Diet
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Diet will be assessed with the Nutrient Data Systems Report is a 24-item recall delivered by a trained nutritionist. This recall provides detailed intake information about over 150 different nutrients as well as food groups.39 Analysis of aims will use total intake of sodium and lipids.
measure: Change in Self-management behaviors- Exercise
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Exercise will be assessed with actigraphy. Intensity and number of minutes of exercise will be assessed over a three-day period using the Actigraph Active Living Protocol. Total number of minutes and number of minutes in moderate to high intensity of exercise will be used for analysis of study aims.
measure: Change in Emotion regulation
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Emotion regulation will be measured with the 16-item Emotional Regulation Profile-Revised.
measure: Change in Stress
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Stress will be measured with the 10-item Perceived Stress Scale(PSS). PSS items are on a 5-point Likert-type scale and include subjective statements related to stress experienced in the last 30 days.
measure: Change in Patient Activation
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Patient activation will be measured with the 10-item Patient Activation Measure.
measure: Change in Self-efficacy
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Self-efficacy will be measured with the 6-item Self Efficacy for Managing Chronic Disease scale.
measure: Change in Neural Function Brain Activation
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Brain activation will be assessed using functional Magnetic Resonance Imaging (fMRI). Neural network differentiation will be assessed using passive viewing of video clips, each 23 seconds in length. Half of the video clips will assess analytic thinking, and half empathetic/emotional cognition. Brain activity associated with each of these conditions will be assessed relative to a resting baseline, achieved by including fixation conditions of the same length and frequency as the video stimuli. All stimuli are presented with EPrime psychology software.
measure: Change in Decision making
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Decision making will be assessed with the Iowa gambling task. This task will be conducted to assess decision making with a real-life simulation. In this task participants select decks of cards with the goal of winning as much money as possible.
measure: Change in Attention
time frame: baseline, after completion of standard of care cardiac rehabilitation, and 3 months after completion of standard of care cardiac rehabilitation (an average of 5 months).
description: Attention will be measured with the 13 item Attention Function Index.
arm group label: Control
arm group type: No Intervention
description: Usual cardiac rehabilitation and social phone calls for attention control.
arm group label: Intervention
arm group type: Experimental
description: RENEwS intervention is five 60-minute group educational sessions.
intervention type: Other
intervention name: RENEwS
description: The intervention participants will meet with a trained interventionist for five 60-minute sessions as a group (two groups of five participants each). In the sessions time will be divided between didactic presentation of material, active practicing of techniques, group work focused on case studies, and worksheets for further practice at home. Topics covered within the intervention include emotional awareness, balancing emotional and physical wellbeing, selecting and implementing emotion regulation strategies (such as situation selections, mindfulness, engagement/avoidance, reappraisal, and emotional sharing), and emotional monitoring.
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Kelly Wierenga
investigator title: Postdoctoral Fellow
mesh term: Myocardial Infarction
mesh term: Heart Diseases
mesh term: Infarction