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

NCT ID: NCT05341440

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-22

Study Completion Date

2024-06-22

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bar-Ilan University, Israel

OTHER

Sponsor Role lead

Responsible Party

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Noa Vilchinsky

prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, Hamercaz, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Jenny Gutman

Role: CONTACT

0547851988

Facility Contacts

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Jenny Gutman

Role: primary

+972547851988

Other Identifiers

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27122021

Identifier Type: -

Identifier Source: org_study_id

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