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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341440
• Other study ID #: 27122021
• Status: Recruiting
• Start date: March 22, 2022
• Est. completion date: June 22, 2024

Study information

• Verified date: February 2023
• Source: Bar-Ilan University, Israel
• Contact: Jenny Gutman
• Phone: 0547851988
• Email: jenny.e.gutman[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: June 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan	Hamercaz

Sponsors (1)

Lead Sponsor	Collaborator
Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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