Loneliness and Social Connection in Cardiovascular Disease

NCT ID: NCT04195620

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-01-01

Brief Summary

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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

High self-disclosure

Intervention Type: OTHER

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?"

Low self-disclosure

Intervention Type: OTHER

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?"

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.

Group Type: EXPERIMENTAL

High self-disclosure

Intervention Type: OTHER

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?"

Low self-disclosure

Intervention Type: OTHER

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?"

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.

Group Type: EXPERIMENTAL

High self-disclosure

Intervention Type: OTHER

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?"

Low self-disclosure

Intervention Type: OTHER

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?"

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.

Group Type: EXPERIMENTAL

High self-disclosure

Intervention Type: OTHER

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?"

Low self-disclosure

Intervention Type: OTHER

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?"

Interventions

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?"

Intervention Type: 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?"

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Morehead State University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Maitland

Assistant Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Morehead State University

Morehead, Kentucky, United States

Countries

United States

Other Identifiers

HRVLoneliness

Identifier Type: -

Identifier Source: org_study_id