Loneliness and Social Connection in Cardiovascular Disease

NCT04195620 | Terminated

• 1 other identifier: HRVLoneliness
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Loneliness; Sympathetic Nervous System; Parasympathetic Nervous System; Vulnerability; Self-disclosure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Self-reported Feelings of Connection

  50 minutes

Study Arms (4)

Low loneliness, low self-disclosure

EXPERIMENTAL

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; Other: Low self-disclosure

Low loneliness, high self-disclosure

EXPERIMENTAL

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; Other: Low self-disclosure

high loneliness, low self-disclosure

EXPERIMENTAL

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; Other: Low self-disclosure

high loneliness, high self-disclosure

EXPERIMENTAL

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; Other: Low self-disclosure

Interventions

High self-disclosure 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 loneliness, high self-disclosure; Low loneliness, low self-disclosure; high loneliness, high self-disclosure; high loneliness, low self-disclosure

Low self-disclosure 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; Low loneliness, low self-disclosure; high loneliness, high self-disclosure; high loneliness, low self-disclosure

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Morehead State University: lead

Study Sites (1)

Morehead State University

Morehead, Kentucky, 40351, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator will be naïve to participant treatment condition. All other individuals will know or it will be obvious to them.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: 2x2 factorial design assessing different levels of loneliness and those individuals being randomized to one of two conditions involving either high levels of self-disclosure or low levels of self-dislcosure

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: September 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Pending completion of data collection and cleaning.

Locations

US (1)