Keep Social Study for Young Adults

Official title

Ameliorating Social Isolation: Identifying Factors That Impede or Facilitate Health-related Social Behavior Change

Overview

The Keep Social randomized control trial (RCT) is a 6-week, online study which will test whether, relative to a placebo control condition, an intervention that encourages high-quality in-person social interactions with strangers and acquaintances reduces young adults' (ages 18 - 29) social isolation and loneliness. Participants will complete our 6-week protocol, which includes 6 weeks of passive ecological behavior sampling (i.e., geotracking) and Day Reports, our 4-week Invibe social media messages, plus recurrent Biweekly Assessments (BW1-BW4) that include both self-reported and behavioral measures. The first Monday following enrollment, participants complete the BW1 baseline survey to assess demographic characteristics and initial levels of all outcome variables (primary and secondary, \~20 min). They also (optionally) activate passive geotracking on this day and leave it activated, continuously, for the duration of the study. During the 2-week baseline and 4-week Invibe phases, time-varying psychological and behavioral mediators and moderators will be assessed three times per week via Day Reports. To increase ecological validity, each week, two weekdays (i.e., Monday, Tuesday, Wednesday, or Thursday), and one weekend day (i.e., Friday, Saturday or Sunday) will be randomly selected. Day reports will not be assigned on Mondays if there is a biweekly assessment scheduled.

Detailed description

Social isolation and its subjective counterpart loneliness-well established as risk factors for poor physical and mental health-have been rising at alarming rates in the US, especially among young adults. Mechanistic understanding of how best to build social connectedness to ameliorate social isolation is sorely needed to redirect life trajectories toward health and well-being. In creating this foundational knowledge, variations across individuals and geographic location merit focus because these variations may be associated with unique challenges and opportunities for initiating social interactions. The broad, overarching objective of this work is to conduct basic experimental research on social connectedness to test whether, how, where, and for whom health communication messages can motivate in-person interactions to reduce young adults' social isolation and loneliness. Our multi-disciplinary team brings together expertise in social psychology, emotion science, communication science, and public health and will carry out a 6-week randomized controlled trial-the Keep Social RCT-using our innovative and ecologically valid simulated social media platform and a suite of rigorous repeated measures of social behavior, loneliness, and other health relevant outcomes.

This program of research is designed to meet three specific aims. SPECIFIC AIM 1 is to use optimized health messages about the value of social connectedness for young adults (ages 18-29) to conduct the Keep Social RCT to build a rich empirical platform. Initial empirical work has already used a human-centered process to design health communication messages that included peer imagery and stories and tested them in an online experiment with \>700 young adults. Messages that received the highest ratings for encouraging in-person interactions in this online experiment were selected for the Keep Social RCT, which is placebo-controlled with behavioral and survey assessments repeated over six weeks. SPECIFIC AIM 2 is to analyze theory-driven mechanisms through which health communication messages in the Keep Social RCT may reduce young adults' social isolation and loneliness to identify intervention targets. This aim will be met with longitudinal statistical modeling to test whether and how the experimental health communication messages improve social connectedness. SPECIFIC AIM 3 is to extend data analyses of the Keep Social RCT to identify moderators of reduced social isolation and loneliness to identify where and for whom effects are largest. This aim will be met with advanced statistical modeling to illuminate the conditions under which our health communication messages most effectively ameliorate social isolation and loneliness in young adults. Taken together, this research will provide a framework to identify intervention targets to guide subsequent translational work undertaken to reduce loneliness that has been increasing across the US.

Interventions

• Behavioral Experimental Health Communication
  Participants view a brief psychoeducational video about the value of connecting in-person with others and receive guided instructions for creating if-then behavioral plans for increasing moments of high-quality social connection. Over the next four weeks, they view messages on a simulated social media platform to encourage in-person, connections with strangers and acquaintances on a platform called Invibe. The Invibe feed will also have approximately 15 background posts each day from "users'" ab
• Behavioral Simulated Social Media Platform Only
  To rule out placebo and nonspecific effects, the Keep Social RCT engenders positive expectations in all participants by promoting the use of Invibe as a beta social media platform to build and maintain social ties, a framing that mirrors information-as-usual for wellness through social media connections. Those in the Placebo Control condition receive no further health communication (view no psychoeducational video) and encounter all background content on Invibe (all target messages excluded) wit

Primary outcome measures

• Quantity of locations visited as a potential indicator of social opportunity or isolation [Time frame: Continuous over the duration of the 6-week study]
• Roaming entropy as a potential indicator of social opportunity or isolation [Time frame: Continuous over the duration of the 6-week study]
• Left Home (Yes/No) as a potential indicator of social opportunity or isolation [Time frame: Continuous over the duration of the 6-week study]
• Loneliness, Self-Report (Biweekly) [Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6]
• Loneliness, Self-Report (Day) [Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]
• Behavioral Motivational Value for Strangers-Smiling-with-Direct-Gaze [Time frame: Week 4]
• Social Connection, Open Text [Time frame: Week 6]

Secondary outcome measures (12)

• Anxiety, Self-Report [Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6]
• Depression, Self-Report [Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6]
• Stress, Self-Report [Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6]
• Flourishing Mental Health, Self-Report [Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6]
• Life Satisfaction, Self-Report [Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6]
• Belongingness, Self-Report [Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6]
• Alcohol Consumption [Time frame: Week 2 and Week 6]
• Illness Symptoms, Self-Report [Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]
• Physical Pain, Self-Report [Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]
• Openness to Social Interactions (Behavioral Adherence), Self-report [Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]]
• Initiation of Social Interactions (Behavioral Adherence), Self-Report [Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]]
• Emotional Quality of Social Interactions, Self-Report [Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]]

Eligibility criteria

Inclusion criteria

• Use social media
• Own a smartphone
• Reside in urban or suburban regions
• Meet one or more criteria for membership in a sociodemographic population with increased risk of adverse health outcomes in the U.S.: at least 500 participants who identity as Black or African American, at least 500 participants who identify as Hispanic, at least 500 participants with low subjective social status - i.e., who report a 5 or lower on the MacArthur Subjective Social Status (SSS) ladder). Groupings are not mutually exclusive.

Exclusion criteria

• Reside in rural region

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Basic science

Study locations

United States · 1 center

• University of North Carolina at Chapel Hill — Chapel Hill

Publications

• Rice EL, Fredrickson BL. Of passions and positive spontaneous thoughts. Cognit Ther Res. 2017 Jun;41(3):350-361. doi: 10.1007/s10608-016-9755-3. Epub 2016 Feb 3. PMID 35655861
• Catalino LI, Boulton AJ. The Psychometric Properties of the Prioritizing Positivity Scale. J Pers Assess. 2021 Sep-Oct;103(5):705-715. doi: 10.1080/00223891.2020.1828433. Epub 2020 Nov 9. PMID 33166185
• Major BC, Le Nguyen KD, Lundberg KB, Fredrickson BL. Well-Being Correlates of Perceived Positivity Resonance: Evidence From Trait and Episode-Level Assessments. Pers Soc Psychol Bull. 2018 Dec;44(12):1631-1647. doi: 10.1177/0146167218771324. Epub 2018 May 13. PMID 29756547
• Waugh CE, Porth AP, Fang X, Sands LP, Kishida KT. What do we actually want to experience? A computational metric for assessing reward values. Res Sq [Preprint]. 2025 Feb 17:rs.3.rs-5875678. doi: 10.21203/rs.3.rs-5875678/v1. PMID 40034432
• Salsman JM, Lai JS, Hendrie HC, Butt Z, Zill N, Pilkonis PA, Peterson C, Stoney CM, Brouwers P, Cella D. Assessing psychological well-being: self-report instruments for the NIH Toolbox. Qual Life Res. 2014 Feb;23(1):205-15. doi: 10.1007/s11136-013-0452-3. Epub 2013 Jun 16. PMID 23771709

Identifiers

NCT: NCT07005817 · 24-1184 · 1R01MD018492-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗