Loneliness and Social Connection in Cardiovascular Disease

The Role of Vulnerability and Responsiveness in Cardiovascular Disease Biomarkers Associated With Loneliness

The study evaluates the impact of vulnerable self-disclosure and perceived responsiveness in individuals across levels of loneliness. Participants will be randomized to a high disclosure or a low disclosure condition.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: High self-disclosure; Other: Low self-disclosure

Detailed Description

Recent studies have found that loneliness has the same impact on morbidity and mortality as smoking cigarettes and twice that of obesity. One proposed pathway by which loneliness impacts morbidity and mortality is through cardiovascular disease. Loneliness is regularly associated with increased sympathetic nervous system and decreased parasympathetic nervous system engagement, both reliable biomarkers of increased risk of cardiovascular disease. One possible explanation for the this phenomena is that individuals who experience loneliness experience meaningful disruptions to the interpersonal process where they fail to disclose when appropriate or react to other individuals disclosure. This may result in engagement of nervous system regulation of social behaviors resulting in both in the moment and long term engagement of the sympathetic nervous system. The proposed 2-year research plan will examine the behaviors and nervous system reactions of individuals across loneliness levels in an experimental condition that manipulates the probability of engaging in relationship building behaviors.

This study will recruit 60 individuals aged 18-25 who are fluent in English and report no history of cardiovascular or respiratory disease to participate in a study investigating social interactions. While a specific level of loneliness is not an inclusion variable, to ensure representation across loneliness levels, the investigators will screen for levels of loneliness and invite individuals to participate equally distributed between 4 levels of loneliness: 1 or more standard deviations below the mean, between 0-1 standard deviations below the mean, between 0-1 standard deviations above the mean, and 1 standard deviation or more above the mean.

The study will then utilize a 2x2 factorial design splitting participants into reporting above or below the mean level of loneliness and randomizing those individuals to a behavioral task condition that involves answering either a high disclosure or low disclosure set of questions. Before engaging in the behavioral task, participants will fill out a series of questionnaires assessing their current social functioning. Participants will then have baseline levels of sympathetic nervous system and parasympathetic nervous system engagement measured. In an ongoing way, throughout the behavioral task, participants will have their of sympathetic nervous system and parasympathetic nervous system engagement measured. Every 15 minutes, the behavioral task will stop and participants will complete a series of questionnaires assessing their evaluation of their behavior with the research assistant in the task, as well as feelings of connection they are experiencing with the research assistant. At the conclusion of the behavioral task, participants will be invited back to participate in the condition they had not previously completed with a new research assistant. All behavioral tasks will be coded by trained research assistants assessing third party evaluation of relationship building behaviors.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Morehead, Kentucky, United States, 40351
      • Morehead State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being between the ages (inclusive) of 18-25
• English as a primary language
• Provides consent

Exclusion Criteria:

• Known heart condition
• Known respiratory condition
• Inability to transport themselves to and from Morehead State University's campus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low loneliness, low self-disclosure; Individuals in this arm report lower levels of loneliness than the mean level reported by similar individuals. They will start the study in the low self-disclosure group which involves questions that are unlikely to involve meaningful personal disclosure. All members of this group will also complete the high self-disclosure condition later in the study.	Other: High self-disclosure; The high self-disclosure condition involves individuals asking and answering a series of questions that are more personal in nature and involve sharing or receiving information that is likely to be emotionally laden and information that is not readily shared in typical conversations. An example of a question from this condition includes "If you were to die today without the chance to speak with anyone, what would you most regret not having said to someone? Why haven't you said it yet?"; Other: Low self-disclosure; The low self-disclosure condition involves individuals asking and answering a series of questions that are not personal in nature and involve sharing or receiving information that is shared in very casual conversations. An example of a question from this condition includes "What did you do to celebrate Halloween last year?"
Experimental: Low loneliness, high self-disclosure; Individuals in this arm report lower levels of loneliness than the mean level reported by similar individuals. They will start the study in the high self-disclosure group which involves questions that are likely to involve meaningful personal disclosure. All members of this group will also complete the low self-disclosure condition later in the study.	Other: High self-disclosure; The high self-disclosure condition involves individuals asking and answering a series of questions that are more personal in nature and involve sharing or receiving information that is likely to be emotionally laden and information that is not readily shared in typical conversations. An example of a question from this condition includes "If you were to die today without the chance to speak with anyone, what would you most regret not having said to someone? Why haven't you said it yet?"; Other: Low self-disclosure; The low self-disclosure condition involves individuals asking and answering a series of questions that are not personal in nature and involve sharing or receiving information that is shared in very casual conversations. An example of a question from this condition includes "What did you do to celebrate Halloween last year?"
Experimental: high loneliness, low self-disclosure; Individuals in this arm report higher levels of loneliness than the mean level reported by similar individuals. They will start the study in the low self-disclosure group which involves questions that are unlikely to involve meaningful personal disclosure. All members of this group will also complete the high self-disclosure condition later in the study.	Other: High self-disclosure; The high self-disclosure condition involves individuals asking and answering a series of questions that are more personal in nature and involve sharing or receiving information that is likely to be emotionally laden and information that is not readily shared in typical conversations. An example of a question from this condition includes "If you were to die today without the chance to speak with anyone, what would you most regret not having said to someone? Why haven't you said it yet?"; Other: Low self-disclosure; The low self-disclosure condition involves individuals asking and answering a series of questions that are not personal in nature and involve sharing or receiving information that is shared in very casual conversations. An example of a question from this condition includes "What did you do to celebrate Halloween last year?"
Experimental: high loneliness, high self-disclosure; Individuals in this arm report higher levels of loneliness than the mean level reported by similar individuals. They will start the study in the high self-disclosure group which involves questions that are likely to involve meaningful personal disclosure. All members of this group will also complete the low self-disclosure condition later in the study.	Other: High self-disclosure; The high self-disclosure condition involves individuals asking and answering a series of questions that are more personal in nature and involve sharing or receiving information that is likely to be emotionally laden and information that is not readily shared in typical conversations. An example of a question from this condition includes "If you were to die today without the chance to speak with anyone, what would you most regret not having said to someone? Why haven't you said it yet?"; Other: Low self-disclosure; The low self-disclosure condition involves individuals asking and answering a series of questions that are not personal in nature and involve sharing or receiving information that is shared in very casual conversations. An example of a question from this condition includes "What did you do to celebrate Halloween last year?"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Sinus Arrhythmia	Respiratory sinus arrhythmia (RSA) is heart rate variability in synchrony with respiration. RSA is considered a reliable way to measure parasympathetic innervation of the heart mediated by the vagus nerve.	50 minutes
Electrodermal Activity	Electrodermal activity (EDA) is the property of the body that results in variation in the electrical characteristics of the skin. It is thought that skin resistance varies as a function of the state of sweat glands in the skin and that sweating is controlled by the sympathetic nervous system. Consequently, EDA is viewed as a non-invasive measure of sympathetic nervous system activity.	50 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Feelings of Connection	The Social Connectedness Scale: Research Assistant. The minimum score on the measure is 6, the maximum is 36. Higher scores on the measure indicate more feelings of connection. The measure is a composite of 6 questions assessing feelings of connection reported by the participant. All 6 questions are measured on a scale of 1-6.	50 minutes

Collaborators and Investigators

• Sponsor: Morehead State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Loneliness; Sympathetic Nervous System; Parasympathetic Nervous System; Vulnerability; Self-disclosure
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: HRVLoneliness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Given that the data collected contains no identifiers, all IPD will be made available.
• IPD Sharing Time Frame: Pending completion of data collection and cleaning.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No