Clinical trial NCT05899413: Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding
Official title: Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Vagus Nerve Stimulation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-06-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couple dyads will be randomly assigned to receive either tVNS or sham stimulation.
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to understand the role of the vagus nerve in promoting social bonding by using a non-invasive stimulation technique called transcutaneous vagal nerve stimulation (tVNS). The investigators will investigate whether tVNS can improve emotional, physiological, and behavioral experiences during and after social interactions. Couples will be randomly assigned to receive either tVNS or a sham stimulation during gratitude expression and problem-solving discussions. The investigators will measure their subjective evaluations of the interactions and capture their physiological and behavioral synchrony. This research will shed light on the processes involved in social connection and explore the potential of tVNS as a tool to enhance bonding in close relationships.

Detailed description: As fundamental as the need to belong is to human survival and functioning, decades of research have shown that social connection is critical to emotional well-being. The current investigation seeks to use the knowledge and technological advances in the biomedical field to examine the causal role of the vagus nerve in promoting social bonding. Specifically, building on the recent evidence suggesting the effects of transcutaneous vagal nerve stimulation (tVNS) on improving social cognitive functioning, this study will examine the utility of tVNS in modulating emotional, physiological, and behavioral experiences during and after social interactions. The investigators will examine if romantic couple assigned to receive tVNS vs. active sham stimulation during two types of conversations (i.e., gratitude expression and problem-solving discussion) show differences in their experiences of the interactions. The study outcomes will include subjective evaluations of the interaction (e.g., felt emotions) and their physiological synchrony. This investigation will provide insights into the mechanistic processes that undergird social connection and, importantly, be the first to examine the potential utility of tVNS as an intervention tool for promoting social bonding within close relationships.

Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Having been in a relationship with the partner for at least a year
* Within the age range of 18-39

Exclusion Criteria:

* Major chronic disease. self-reported autoimmune disease; severe asthma; lung disease (such as chronic bronchitis; history of stroke, heart attack, epilepsy, brain injury); cardiovascular disease.
* Cancer: if not in remission.
* Substance dependence-current or long history (5 years of more).
* Current psychiatric diagnosis that is not being treated with medication
* Confounding medications, including those used to treat hypertension and cardiovascular conditions; psychoactive substances; and medications known to directly affect autonomic functioning.

Primary outcomes:
measure: Self-reported Positive Affect
timeFrame: Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes
measure: Self-reported Negative Affect
timeFrame: Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes
measure: Respiratory Sinus Arrhythmia
timeFrame: Continuously throughout conflict conversation
measure: Interbeat Interval
timeFrame: Continuously throughout the conflict conversation
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Nancy Friend Pritzker Psychiatry Building
state: California
Study officials:
References:
citation: Chung JM, Harari GM, Denissen JJ. Investigating the within-person structure and correlates of emotional experiences in everyday life using an emotion family approach. Journal of Personality and Social Psychology. 2022;122(6):1146-1189.