- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07223099
Sauna for Offline Connections and Interactive, Authentic Living (SOCIAL)
This pilot trial will test an intervention (sauna visits) targeting reductions in loneliness in adults aged 19-22 years.
Participants will:
- Visit a sauna in San Francisco once per week for 2 hours by themselves or with a friend, for 8 weeks total
- Complete online surveys throughout their participation
The main question this pilot trial aims to answer are:
- To what extent do participants find the study design acceptable?
- To what extent do participants complete the weekly sauna visits?
- To what extent do participants complete the weekly online surveys?
Study Overview
Detailed Description
In the U.S. today, emerging adults (i.e., ages 19 to 22) report high levels of loneliness and social isolation, which are significant risk factors for myriad poor health outcomes. This formative period of emerging adulthood is arguably among the most critical of times: it is when the people who comprise our next generation of leaders have some of their earliest opportunities to build their identities as curious about, accepting of, and open to differences from their peers.
Traditional sauna bathing is a social, mental, and physical health practice associated with greater mental wellness and active social engagement. Recent studies also suggest that thermal therapies, including sauna, may reduce depressive symptoms, which contribute to loneliness and social isolation. Sauna bathing is deeply integrated into the social fabric of several cultures, most notably Finland where it serves as a communal activity that fosters social connection and may help reduce loneliness.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah M Fisher, MS
- Phone Number: 415-476-1218
- Email: sarah.fisher4@ucsf.edu
Study Contact Backup
- Name: SOCIAL Study Team
- Phone Number: 415-514-8445
- Email: socialstudy@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- Recruiting
- Osher Center for Integrative Health
-
Contact:
- Sarah M Fisher, MS
- Phone Number: 415-476-1218
- Email: socialstudy@ucsf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 19-22
- English-speaking
- Able to provide written informed consent
- Graduated from high school or high school equivalent
- Elevated level of loneliness
- Able and willing to receive study text messages
- Able to attend weekly in-person sauna visits in San Francisco, CA
Exclusion Criteria:
- Self-reported heat intolerance
- Pregnancy, active lactation, or intention to become pregnant during the study period
- Regular use of any nicotine products, including cigarettes, vapes, chewing tobacco, or other forms of nicotine (if use is not regular, must be willing to refrain for 24 hours before and 24 hours after sauna visits)
- Current social heat practices 2 or more times per month (e.g., visiting sauna or hot tub facilities with others present)
- Unwilling to refrain from using marijuana products and alcohol for the 24 hours before and 24 hours after sauna visits
- Unwilling to refrain from heavy exercise on the day of sauna visits
- Any medical condition that, in the opinion of investigators, may increase the risk of sauna use or introduce excessive variance into physiological or behavioral responses to sauna visits
- Use of any medication that might impact thermoregulatory capacity or that, in the opinion of investigators, would increase risk of study participation or introduce excessive variance into physiological or behavioral responses to sauna visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sauna Visits
Participants will complete 2-hour visits, by themselves or with another person of their choosing, to a local sauna in San Francisco for 8 weeks.
|
Weekly 2-hour visits to a sauna in San Francisco by themselves or with one person of their choice for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation Acceptability
Time Frame: 8 weeks
|
Average rating on the following net promoter item: "Thinking about everything that participating in this study involved (completing screening activities, visiting the sauna, doing questionnaires), would you recommend participating in this study to a friend or family member looking to reduce their feelings of loneliness?"
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Adherence
Time Frame: 8 weeks
|
Proportion of study sauna visits attended (out of 8)
|
8 weeks
|
|
Weekly Survey Completion
Time Frame: 8 weeks
|
Proportion of weekly surveys completed (out of 8)
|
8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ashley E Mason, PhD, University of California, San Francisco
Publications and helpful links
General Publications
- Patrick RP, Johnson TL. Sauna use as a lifestyle practice to extend healthspan. Exp Gerontol. 2021 Oct 15;154:111509. doi: 10.1016/j.exger.2021.111509. Epub 2021 Aug 5.
- Laukkanen JA, Kunutsor SK. The multifaceted benefits of passive heat therapies for extending the healthspan: A comprehensive review with a focus on Finnish sauna. Temperature (Austin). 2024 Feb 25;11(1):27-51. doi: 10.1080/23328940.2023.2300623. eCollection 2024.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SOCIAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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