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

NCT ID: NCT03303703

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2018-10-31

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.

Conditions

Cardiac Disease; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

Usual cardiac rehabilitation and social phone calls for attention control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

RENEwS intervention is five 60-minute group educational sessions.

Group Type: EXPERIMENTAL

RENEwS

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Kelly Wierenga

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Case Western Reserve University

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32205788 (View on PubMed)

Other Identifiers

ANF6098

Identifier Type: -

Identifier Source: org_study_id