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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:7/12/2018
Start Date:October 11, 2017
End Date:October 31, 2018

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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.

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
We found this trial at
1
site
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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mi
from
Cleveland, OH
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