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

NCT05341440 | Unknown

• 1 other identifier: 27122021
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (7)

• 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Hamercaz, Israel

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Jenny Gutman

CONTACT

0547851988; jenny.e.gutman@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 22, 2022
• Study Start: March 22, 2022
• Primary Completion: March 22, 2024
• Study Completion: June 22, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

IL (1)