Clinical trial NCT05341440: Deciphering the Salutogenic Effects of Close Relationships: Psycho-physiological Coregulation Processes and Their Outcomes in Couples Coping With Cardiovascular Disease
Official title: Deciphering the Salutogenic Effects of Close Relationships: Psycho-physiological Coregulation Processes and Their Outcomes in Couples Coping With Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 81
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 months
measure: The Warwich-Edinburgh Mental Well-being Scale
timeFrame: 3 months
measure: Smoking cessation
timeFrame: 3 months
measure: The Medication Adherence Report Scale
timeFrame: 3 months
measure: Cardiac rehabilitation participation
timeFrame: 3 months
measure: Weight change
timeFrame: 3 months
measure: Fitness change
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: Hamercaz
Study officials:
References: