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

March 20, 2020 updated by: Kelly Wierenga, Case Western Reserve University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Usual cardiac rehabilitation and social phone calls for attention control.
Experimental: Intervention
RENEwS intervention is five 60-minute group educational sessions.
Other: RENEwS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Depression will be measured with the 16 item Quick Inventory of Depressive Symptomatology and PROMIS depression-4.
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).
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).
Anxiety will be assessed using the 7 anxiety items from the short-form of the Depression Anxiety Stress Scale and the PROMIS anxiety-4.
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).
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).
Rumination will be measured with the 22-item Ruminative Responses Scale.
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).
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).
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.
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).
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).
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.
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).
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).
Emotion regulation will be measured with the 16-item Emotional Regulation Profile-Revised.
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).
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).
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.
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).
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).
Patient activation will be measured with the 10-item Patient Activation Measure.
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).
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).
Self-efficacy will be measured with the 6-item Self Efficacy for Managing Chronic Disease scale.
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).
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).
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.
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).
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).
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.
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).
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).
Attention will be measured with the 13 item Attention Function Index.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANF6098

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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