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临床试验/NCT04195620
NCT04195620终止不适用

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

Morehead State University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
34
试验地点
2
主要终点
Electrodermal Activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Single (Investigator)

盲法说明

The investigator will be naïve to participant treatment condition. All other individuals will know or it will be obvious to them.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Electrodermal Activity

时间窗: 50 minutes

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.

Respiratory Sinus Arrhythmia

时间窗: 50 minutes

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.

次要结局

  • Self-reported Feelings of Connection(50 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Maitland

Assistant Professor of Psychology

Morehead State University

研究点 (2)

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