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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05341440
Enrollment
81
Registered
2022-04-22
Start date
2022-03-22
Completion date
2024-06-22
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

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).

Interventions

None listed

Sponsors

Bar-Ilan University, Israel
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No

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. *

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale3 monthscontains 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'.
The Warwich-Edinburgh Mental Well-being Scale3 monthsA 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.
Smoking cessation3 monthsSmoking 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.
The Medication Adherence Report Scale3 monthsPatients 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.
Cardiac rehabilitation participation3 monthsThe 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.
Weight change3 monthsWeight change is defined as the delta between patients' body-mass index (BMI) from the beginning of rehabilitation and 3 months in.
Fitness change3 monthsWill 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).

Countries

Israel

Contacts

Primary ContactJenny Gutman
jenny.e.gutman@gmail.com0547851988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026