An interventional study of Experimental Health Communication and Simulated Social Media Platform Only in Social Isolation and Loneliness, sponsored by University of North Carolina, Chapel Hill. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science
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.
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.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's planned enrollment of 1,900 is above the median of 80 across 198 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Participants are exposed to a brief psychoeducational video, guided instructions for creating if-then behavioral plans, a simulated social media platform with background content, and target messages within the platform that encourage in-person social interactions with strangers and acquaintances.
Behavioral: Experimental Health Communication
Participants are exposed to a simulated social media platform with background content.
Behavioral: Simulated Social Media Platform Only
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'" about their lives, including food, fitness, pets, and travel, common on social media platforms. During the 4-week Invibe phase, after participants complete each Day Report, they will view the Invibe simulated social media feed. Participant exposure to each target message will be both passive, via that day's feed, and forced, via inclusion on the Day Report. Participants will see 12 social media messages during this 4-week phase, shown in random order within the first 3 daily posts.
Also known as: Educational Video, Simulated Social Media Platform, and Target Messages
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) with control posts that feature unrelated content.
Also known as: Placebo Control Communication
Quantity of locations visited as a potential indicator of social opportunity or isolation
Participants will be asked to download a geolocation app to their smartphone that tracks their physical location throughout the study. Number of locations visited is a count variable (integers), with a lower bound of zero and an upper bound to be determine by participant behavior.
Time frame: Continuous over the duration of the 6-week study
Roaming entropy as a potential indicator of social opportunity or isolation
Based on GPS data (i.e., coordinates and timestamps), roaming entropy (RE) scores are computed with RE higher for days where one visits a greater number of locations and exhibits greater uniformity in the time distribution across visited locations. A minimum RE value would be achieved by spending all day in a single location, whereas maximum RE would, theoretically, be achieved by spending an equal proportion of the day in each unique location in an environment. Possible range is 0.00 to 1.00; range in past datasets is 0.00 to 0.52.
Time frame: Continuous over the duration of the 6-week study
Left Home (Yes/No) as a potential indicator of social opportunity or isolation
This is a binary Indicator of whether the participant visited any location outside of the home cluster, defined as the location most frequently visited between 2:00 AM and 6:00 AM.
Time frame: Continuous over the duration of the 6-week study
Loneliness, Self-Report (Biweekly)
Four items from the National Institute of Health (NIH) Toolbox Adult Social Relationship Scales with mean responses ranging from 1 to 5. Lower scores indicate reduced loneliness.
Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6
Loneliness, Self-Report (Day)
One item: "Today, I felt lonely." Mean scores range from 1 to 7 with a lower score representing less loneliness.
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT
Behavioral Motivational Value for Strangers-Smiling-with-Direct-Gaze
The behavioral measure of motivational value (a.k.a., Implicit Motivational Value, or iMV) is estimated in a choice task as k values for stimulus types using a reinforcement learning (RL) paradigm and computational approaches. The task stimuli include fractals that precede the presentation of headshot photos of unfamiliar others in the same age range as study participants. Those photos show persons with one of 3 facial expressions: smiling-with-direct-gaze, smiling-with-gaze-averted, and neutral-with-gaze-averted. Participants are instructed to select their preferred fractal. Following work by Waugh et al. Computational a priori starting range: -1.5 to 1.5, with higher means representing more motivation to experience the image type (e.g., strangers-smiling-with-direct-gaze) relative to the middle category (i.e., strangers-smiling-with-gaze-averted).
Time frame: Week 4
Social Connection, Open Text
Participants will respond to an open-ended writing prompt asking them to reflect on how socially connected (or not) they felt during the study. To index social connection, both top-down (theory-driven) dictionary-based approaches, specifically the Linguistic Inquiry Word Count (LIWC) and also bottom-up (data-driven) open-vocabulary linguistic features (words, phrases, and topics) will be used. LIWC scores represent the relative frequency of designated words within each LIWC category, ranging from 0.0 to 1.0. Higher scores represent greater frequency of the designated word category. Latent Dirichlet Allocation modeling (LDA) will be used to generate "topics" that represent data-driven linguistic features. The investigators will compute the topic distribution of each participant, ranging from 0.0 to 1.0. Higher scores represent greater frequency of the designated topic.
Time frame: Week 6
Anxiety, Self-Report
4-item Patient Reported Outcomes Measurement Information System (PROMIS)-29 measure that assesses participants' frequency of experiencing symptoms of anxiety. As described in the statistical analysis plan, the investigators plan to use the anxiety measure as an indicator in a "negative mental health" latent variable. Mean scores range from 1 to 7 with a lower score representing less anxiety.
Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6
Depression, Self-Report
4-item PROMIS-29 measure that assesses participants' frequency of experiencing symptoms of depression. As described in the statistical analysis plan, the investigators plan to use the depression measure as an indicator in a "negative mental health" latent variable. Mean scores range from 1 to 7 with a lower score representing fewer symptoms of depression.
Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6
Stress, Self-Report
4-item PROMIS-29 measure that assesses participants' frequency of perceiving stress. As described in the statistical analysis plan, the investigators plan to use the measure of perceived stress as an indicator in a "negative mental health" latent variable. Mean scores range from 1 to 7 with a lower score representing decreased stress levels.
Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6
Flourishing Mental Health, Self-Report
14 items from the Mental Health Continuum, Short Form (MHC-SF) assessing flourishing mental health (emotional, psychological, and social well-being). As described in the statistical analysis plan, the investigators plan to use the MHC-SF measure as an indicator in a "positive mental health" latent variable. Scale scores range from 0 to 4 with higher scores used as a proxy for "positive mental health".
Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6
Life Satisfaction, Self-Report
5-item NIH PROMIS survey that assesses participants' frequency of experiencing satisfaction with their life from PROMIS v1.0 -General Life Satisfaction Short Form 5a. As described in the statistical analysis plan, the investigators plan to use the life satisfaction measure as an indicator in a "positive mental health" latent variable. Mean scores range from 1 to 7, with higher scores representing life satisfaction.
Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6
Belongingness, Self-Report
12-item General Belongingness Scale which assesses participants' sense of belonging across multiple levels of social ties and an overall sense of belonging beyond all interpersonal relationships. Mean scores range from 1 to 7 with higher scores indicating a greater sense of belonging.
Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6
Alcohol Consumption
Four items from the CDC's Behavioral Risk Factor Surveillance System (BRFSS) assess the frequency and quantity, respectively, of participants' consumption of alcoholic drinks during the past 30 days. The average daily alcohol consumption is calculated by multiplying the number of drinking days per month, as reported by each drinker, by the average number of drinks consumed per drinking day by each drinker; and then the product of the average total number of drinks consumed by all drinkers is divided by 30 days.
Time frame: Week 2 and Week 6
Illness Symptoms, Self-Report
Participants asked to report the extent to which they experienced illness symptoms on the day they took their survey using the following item: "Today, I felt physically unwell or under the weather." Mean scores range from 1 to 7, with higher scores representing a greater degree of illness.
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT
Physical Pain, Self-Report
One item asks participants the degree to which they felt impeded by bodily sensations of physical pain that day: "Today, I was bothered by physical pain." Mean scores range from 1 to 7, with higher scores indicating more pain.
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT
Openness to Social Interactions (Behavioral Adherence), Self-report
Participants are asked to report on the most recent day when they were out and about. Openness to social interactions is measured with the following item, with scores ranging from 1 to 5: "Today, when out and about, how often were you open to connecting with people you didn't know (or hardly knew)." Higher scores indicate more openness.
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]
Initiation of Social Interactions (Behavioral Adherence), Self-Report
Participants are asked to report on the most recent day when they were out and about. Openness to social interactions is measured with the following item, with scores ranging from 1 to 5: "Today, when out and about, how often did you initiate connecting with people you didn't know (or hardly knew)?" Higher scores represent more initiation from the participant.
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]
Emotional Quality of Social Interactions, Self-Report
2 items from the Perceived Positivity Resonance Scale (Major et al., 2018) which assesses the degree to which participants' in-person social interactions that were characterized by a mutual sense of warmth, concern, and "in sync" with others. Positivity resonance with strangers, less familiar people, and close others are assessed separately. Participants are asked to recall a specific interaction within the last 24 hours with each type of tie (or within past few days if they did not have a social interaction with the relevant tie within the past 24 hours) and then report on the following two items: "During this interaction, to what extent did you experience a mutual sense of warmth and concern toward one another?" and "During this interaction, to what extent did you feel "in sync" with this person?" Mean scores range from 0 to 10, with higher values indicating more positivity resonance.
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT]
Safety/Trust, Self-Report
One item assessing participants' impressions of the context in which they recently interacted with a stranger or acquaintance. Participants recall a specific interaction with a stranger and acquaintance (separately measured). They are asked to recall the place or setting where they had the interaction and rate their agreement or disagreement (1-7 scale) with the following statement: "During the entire time I spent in this location, I felt that someone would stop to help me if I needed it" (emphasis in the original text). Higher scores indicate a higher degree of safety and trust within the environment.
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT
Psychologically Rich Life
5 items from the full scale in Oishi et al. (2020). The items are adapted to assess impressions "this past month." Mean scores range from 1-7, with higher values indicating greater agreement or perceived likelihood.
Time frame: Biweekly assessments 2, 4
Positive Spontaneous Thoughts about Strangers and Less Familiar Others, Self-Report
1 item assessing the positivity of thoughts about strangers and less familiar others, adapted from a more general measure of Positive Spontaneous Thoughts in Rice \& Fredrickson (2016). Scores range from 0 to 100, with higher values indicating more positive thoughts.
Time frame: Biweekly assessment 4
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Time frame: beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed a data use/sharing agreement with UNC
Started May 2025 (actual). Primary completion is estimated for Nov 2027, 30 months after the start.
Of 155 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 30 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
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