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Partnering Physical and Emotional Fitness: Improving Cardiac Recovery With Training in Emotion Regulation

Primary Purpose

Cardiac Disease, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RENEwS
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Disease focused on measuring cardiac rehabilitation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of CVD
  • phase II CR initiated within the past 2 months
  • planned 12 weeks of CR
  • living independently
  • at least 40 years of age

Exclusion Criteria:

  • patients who do not speak English
  • have experienced cardiac arrest
  • have an implanted pacemaker or defibrillator
  • not approved safe for exercise

Sites / Locations

  • Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Usual cardiac rehabilitation and social phone calls for attention control.

RENEwS intervention is five 60-minute group educational sessions.

Outcomes

Primary Outcome Measures

Change in Quality of life
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.

Secondary Outcome Measures

Change in Psychological symptoms- Depression
Depression will be measured with the 16 item Quick Inventory of Depressive Symptomatology and PROMIS depression-4.
Change in Psychological symptoms- Anxiety
Anxiety will be assessed using the 7 anxiety items from the short-form of the Depression Anxiety Stress Scale and the PROMIS anxiety-4.
Change in Psychological symptoms- Rumination
Rumination will be measured with the 22-item Ruminative Responses Scale.
Change in Self-management behaviors- Diet
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.
Change in Self-management behaviors- Exercise
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.
Change in Emotion regulation
Emotion regulation will be measured with the 16-item Emotional Regulation Profile-Revised.
Change in Stress
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.
Change in Patient Activation
Patient activation will be measured with the 10-item Patient Activation Measure.
Change in Self-efficacy
Self-efficacy will be measured with the 6-item Self Efficacy for Managing Chronic Disease scale.
Change in Neural Function Brain Activation
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.
Change in Decision making
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.
Change in Attention
Attention will be measured with the 13 item Attention Function Index.

Full Information

First Posted
September 20, 2017
Last Updated
March 20, 2020
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT03303703
Brief Title
Partnering Physical and Emotional Fitness: Improving Cardiac Recovery With Training in Emotion Regulation
Official Title
Partnering Physical and Emotional Fitness: Improving Cardiac Recovery With Training in Emotion Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Myocardial Infarction
Keywords
cardiac rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual cardiac rehabilitation and social phone calls for attention control.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
RENEwS intervention is five 60-minute group educational sessions.
Intervention Type
Other
Intervention Name(s)
RENEwS
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Quality of life
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.
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).
Secondary Outcome Measure Information:
Title
Change in Psychological symptoms- Depression
Description
Depression will be measured with the 16 item Quick Inventory of Depressive Symptomatology and PROMIS depression-4.
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).
Title
Change in Psychological symptoms- Anxiety
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.
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).
Title
Change in Psychological symptoms- Rumination
Description
Rumination will be measured with the 22-item Ruminative Responses Scale.
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).
Title
Change in Self-management behaviors- Diet
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.
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).
Title
Change in Self-management behaviors- Exercise
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.
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).
Title
Change in Emotion regulation
Description
Emotion regulation will be measured with the 16-item Emotional Regulation Profile-Revised.
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).
Title
Change in Stress
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.
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).
Title
Change in Patient Activation
Description
Patient activation will be measured with the 10-item 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).
Title
Change in Self-efficacy
Description
Self-efficacy will be measured with the 6-item Self Efficacy for Managing Chronic Disease scale.
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).
Title
Change in Neural Function Brain Activation
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.
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).
Title
Change in Decision making
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.
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).
Title
Change in Attention
Description
Attention will be measured with the 13 item Attention Function Index.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of CVD phase II CR initiated within the past 2 months planned 12 weeks of CR living independently at least 40 years of age Exclusion Criteria: patients who do not speak English have experienced cardiac arrest have an implanted pacemaker or defibrillator not approved safe for exercise
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32205788
Citation
Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.
Results Reference
derived

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Partnering Physical and Emotional Fitness: Improving Cardiac Recovery With Training in Emotion Regulation

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