Deciphering the Salutogenic Effects of Close Relationships: Psycho-physiological Coregulation Processes and Their Outcomes in Couples Coping With Cardiovascular Disease

The established attachment theory elucidates how early human bonds bring about functional neurophysiological alterations influencing the lifelong capacity for self and co- regulation within relationships. Based on this framework, the study will investigate potential psycho-physiological co-regulation processes in couples coping with cardiovascular disease, which may explain the established link between relationship satisfaction and recovery outcomes. In the proposed prospective, longitudinal study, the investigators will follow 81 volunteer couples in which one member has experienced an Acute Coronary Syndrome and assess their levels of interactive behavioral synchrony and the accompanying physiological synchrony (the mutual coordination of spouses' autonomic nervous systems), and stress buffering (reduced reactivity to stress in the individual) as assessed by Heart Rate Variability, and Galvanic Skin Response. It is hypothesized that higher levels of physiological synchrony and stress buffering will be associated with enhanced behavioral synchrony in the lab as well as patient outcomes three months later, on three dimensions: emotional (anxiety and depression reduction); behavioral (smoking cessation, medication adherence, cardiac rehabilitation participation) and physical (weight reduction, increased fitness).

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 81

Contacts and Locations

• Study Contact: Name: Jenny Gutman; Phone Number: 0547851988; Email: jenny.e.gutman@gmail.com

Study Locations

• Israel
  • Hamercaz
    • Ramat Gan, Hamercaz, Israel
      • Recruiting
      • Sheba Medical Center
      • Contact: Jenny Gutman; Phone Number: +972547851988; Email: jenny.e.gutman@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The target population will be male patients with the diagnosis of a first Acute Coronary Syndrome who have been registered in the cardiac prevention and rehabilitation center (CPRC) and are in a committed relationship (i.e., cohabiting for at least one year).

Description

Inclusion Criteria:

• First Acute Coronary Syndrome
• In a committed relationship lasting over a year
• Registration at the Cardiac Prevention and Rehabiliation Center (CPRC)

Exclusion Criteria:

• A history of previous cardiac events
• A diagnosis other than Acute Coronary Syndrome, co-morbid conditions (such as cancer),
• Lack of Hebrew as a native language.
• Exclusion criteria for partners will be severe co-morbid conditions with life expectancy of less than 6 months (such as advanced cancer) and lack of Hebrew as a native language.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale	contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'.	3 months
The Warwich-Edinburgh Mental Well-being Scale	A scale of 14 positively worded items for assessing a population's mental wellbeing. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.	3 months
Smoking cessation	Smoking cessation will be defined as the delta between the number of cigarettes smoked before the cardiac event and the number of cigarettes smoked 3 months after the start of rehabilitation.	3 months
The Medication Adherence Report Scale	Patients will be asked to report on their medication adherence, using the Medication Adherence Rating Scale. Responses are summed for a total score ranging between 5 and 25, with higher scores indicating a higher level of adherence.	3 months
Cardiac rehabilitation participation	The number of times patients participated in supervised exercise in the Cardiac Rehabilitation Center. Information regarding Rehabilitation participation will be retrieved from patients' computerized entry files.	3 months
Weight change	Weight change is defined as the delta between patients' body-mass index (BMI) from the beginning of rehabilitation and 3 months in.	3 months
Fitness change	Will be defined as the change in delta between 3 months after the start of rehabilitation ergometry score and the start of rehabilitation ergometry score (in Metabolic Equivalent of Task Score- METs).	3 months

Collaborators and Investigators

• Sponsor: Bar-Ilan University, Israel

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2022
• Primary Completion (ANTICIPATED): March 22, 2024
• Study Completion (ANTICIPATED): June 22, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Cardiovascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: 27122021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No