Trials / Unknown
UnknownNCT05341440
Deciphering the Salutogenic Effects of Close Relationships: Psycho-physiological Coregulation Processes and Their Outcomes in Couples Coping With Cardiovascular Disease
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 81 (estimated)
- Sponsor
- Bar-Ilan University, Israel · Academic / Other
- Sex
- Male
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2022-03-22
- Primary completion
- 2024-03-22
- Completion
- 2024-06-22
- First posted
- 2022-04-22
- Last updated
- 2023-02-08
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT05341440. Inclusion in this directory is not an endorsement.