Clinical Trials Logo
NCT number NCT03303703
Study type Interventional
Source Case Western Reserve University
Contact
Status Not yet recruiting
Phase N/A
Start date October 20, 2017
Completion date March 31, 2018

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Not yet recruiting NCT03252990 - 18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability N/A
Not yet recruiting NCT03156816 - COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction Phase 2
Not yet recruiting NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Recruiting NCT02932722 - Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC) N/A
Recruiting NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction N/A
Recruiting NCT02711631 - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation N/A
Recruiting NCT02876952 - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients N/A
Not yet recruiting NCT02899364 - Sodium Thiosulfate to Preserve Cardiac Function in STEMI Phase 2
Recruiting NCT02551094 - Colchicine Cardiovascular Outcomes Trial (COLCOT) Phase 3
Active, not recruiting NCT02382731 - Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction N/A
Enrolling by invitation NCT02305602 - A Study of VentriGel in Post-MI Patients Phase 1
Completed NCT02552407 - Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis N/A
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Active, not recruiting NCT02374775 - Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamic N/A
Recruiting NCT01942070 - A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction Phase 4
Recruiting NCT01569178 - BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction Phase 3
Active, not recruiting NCT01504191 - Internet-based Cognitive Behavior Therapy After Myocardial Infarction Phase 3
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Recruiting NCT01824641 - Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients Phase 3
Completed NCT01709669 - The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease N/A