Cardiovascular DiseasesNCT04195620
Loneliness and Social Connection in Cardiovascular Disease
A study testing High self-disclosure and Low self-disclosure in people with Cardiovascular Diseases, run by Morehead State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- High self-disclosure and Low self-disclosure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages (inclusive) of 18-25
- English as a primary language
- Provides consent
Who cannot join
- Known heart condition
- Known respiratory condition
- Inability to transport themselves to and from Morehead State University's campus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- High self-disclosure, Low self-disclosure
- Keywords
- Loneliness, Sympathetic Nervous System, Parasympathetic Nervous System, Vulnerability, Self-disclosure
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High self-disclosureOther
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-disclosureOther
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?"
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: High self-disclosure; Other: Low self-disclosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 50 minutes
Secondary outcomes (1)
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.
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Sep 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: University affiliation changed and I was unable to transfer the grant that was funding the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morehead State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Maitland, Morehead State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195620
- Sponsor's protocol ID
- HRVLoneliness
- Status last verified
- Apr 2022
- First submitted
- 10 Dec 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Given that the data collected contains no identifiers, all IPD will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vulnerability and Responsiveness in Cardiovascular Disease Biomarkers Associated With Loneliness
- ClinicalTrials.gov ID
- NCT04195620
- Acronym / sponsor ID
- HRVLoneliness
- Conditions
- Cardiovascular Diseases
- Keywords
- Loneliness, Sympathetic Nervous System, Parasympathetic Nervous System, Vulnerability, Self-disclosure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: University affiliation changed and I was unable to transfer the grant that was funding the project
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Morehead State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Low loneliness, low self-disclosure | Experimental | Other: High self-disclosure, Other: Low self-disclosureIndividuals 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. |
| Low loneliness, high self-disclosure | Experimental | Other: High self-disclosure, Other: Low self-disclosureIndividuals 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. |
| high loneliness, low self-disclosure | Experimental | Other: High self-disclosure, Other: Low self-disclosureIndividuals 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. |
| high loneliness, high self-disclosure | Experimental | Other: High self-disclosure, Other: Low self-disclosureIndividuals 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages (inclusive) of 18-25
- English as a primary language
- Provides consent
Key exclusion criteria (3 listed)
- Known heart condition
- Known respiratory condition
- Inability to transport themselves to and from Morehead State University's campus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High self-disclosureThe 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 loneliness, high self-disclosure, Low loneliness, low self-disclosure, high loneliness, high self-disclosure, high loneliness, low self-disclosure |
| Low self-disclosureThe 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?" | Other | Low loneliness, high self-disclosure, Low loneliness, low self-disclosure, high loneliness, high self-disclosure, high loneliness, low self-disclosure |
Primary outcome
Respiratory Sinus Arrhythmia
Time frame: 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.
Electrodermal Activity
Time frame: 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.
1 secondary outcome
Self-reported Feelings of Connection
Time frame: 50 minutes
Results and safety
The study was stopped early (reason given: University affiliation changed and I was unable to transfer the grant that was funding the project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Yes. Given that the data collected contains no identifiers, all IPD will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High self-disclosure and Low self-disclosure in people with Cardiovascular Diseases, run by Morehead State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: University affiliation changed and I was unable to transfer the grant that was funding the project). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Sinus Arrhythmia (time frame: 50 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.