Social IsolationKSSYANCT07005817
Keep Social Study for Young Adults
A study testing Experimental Health Communication and Simulated Social Media Platform Only in people with Social Isolation and Loneliness, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Loneliness
- What is being tested?
- Experimental Health Communication and Simulated Social Media Platform Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,900 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Reside in rural region
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Ameliorating Social Isolation: Identifying Factors That Impede or Facilitate Health-related Social Behavior Change
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.
Read the 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.
- Conditions
- Social Isolation, Loneliness
- Being tested
- Experimental Health Communication, Simulated Social Media Platform Only
- Keywords
- Keep Social, Online, Young Adult
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Health CommunicationBehavioural
Also called Educational Video, Simulated Social Media Platform, and Target Messages
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.
Simulated Social Media Platform OnlyBehavioural
Also called Placebo Control Communication
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 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. Receives: Behavioral: Experimental Health Communication |
| Placebo Control Arm | Placebo comparator | Participants are exposed to a simulated social media platform with background content. Receives: Behavioral: Simulated Social Media Platform Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Week 6
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Biweekly assessment 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start19 May 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our main models use longitudinal structural equation modeling, multilevel structural equation modeling, multilevel modeling, and regression analysis. Further details are provided in the statistical analysis plan.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Barbara L. Frederickson, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005817
- Sponsor's protocol ID
- 24-1184
- Other IDs
- 1R01MD018492-01
- Acronym
- KSSYA
- Status last verified
- Mar 2026
- First submitted
- 14 May 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 35655861Catalino 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.
PubMed 33166185Major 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.
PubMed 29756547Waugh 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.
PubMed 40034432Salsman 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.
PubMed 23771709
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorating Social Isolation: Identifying Factors That Impede or Facilitate Health-related Social Behavior Change
- ClinicalTrials.gov ID
- NCT07005817
- Acronym / sponsor ID
- KSSYA / 24-1184
- Conditions
- Social Isolation, Loneliness
- Keywords
- Keep Social, Online, Young Adult
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 19 May 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 5 Jun 2025 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Our main models use longitudinal structural equation modeling, multilevel structural equation modeling, multilevel modeling, and regression analysis. Further details are provided in the statistical analysis plan.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Behavioral: Experimental Health CommunicationParticipants 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. |
| Placebo Control Arm | Placebo comparator | Behavioral: Simulated Social Media Platform OnlyParticipants are exposed to a simulated social media platform with background content. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Reside in rural region
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 |
|---|---|---|
| Experimental Health CommunicationAlso: Educational Video, Simulated Social Media Platform, and Target MessagesParticipants 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. | Behavioural | Experimental Arm |
| Simulated Social Media Platform OnlyAlso: Placebo Control CommunicationTo 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. | Behavioural | Placebo Control Arm |
Primary outcome
Quantity of locations visited as a potential indicator of social opportunity or isolation
Time frame: Continuous over the duration of the 6-week study
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.
Roaming entropy as a potential indicator of social opportunity or isolation
Time frame: Continuous over the duration of the 6-week study
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.
Left Home (Yes/No) as a potential indicator of social opportunity or isolation
Time frame: Continuous over the duration of the 6-week study
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.
Loneliness, Self-Report (Biweekly)
Time frame: Baseline/Week 0, Week 2, Week 4, and Week 6
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.
Loneliness, Self-Report (Day)
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT
One item: "Today, I felt lonely." Mean scores range from 1 to 7 with a lower score representing less loneliness.
Behavioral Motivational Value for Strangers-Smiling-with-Direct-Gaze
Time frame: Week 4
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).
Social Connection, Open Text
Time frame: Week 6
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.
15 secondary outcomes
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]
Safety/Trust, Self-Report
Time frame: Included in Day Reports, 3 times a week, over the 6-week RCT
Psychologically Rich Life
Time frame: Biweekly assessments 2, 4
Positive Spontaneous Thoughts about Strangers and Less Familiar Others, Self-Report
Time frame: Biweekly assessment 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 35655861Rice 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.
- Background: PubMed 33166185Catalino 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.
- Background: PubMed 29756547Major 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.
- Background: PubMed 40034432Waugh 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.
- Background: PubMed 23771709Salsman 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.
- Individual participant dataSharing planned: 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.
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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.
Barbara L. Frederickson, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Health Communication and Simulated Social Media Platform Only in people with Social Isolation and Loneliness, run by University of North Carolina, Chapel Hill 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 4 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 19 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quantity of locations visited as a potential indicator of social opportunity or isolation (time frame: Continuous over the duration of the 6-week study). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07005817, which also lists 5 linked publications.
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 19 Mar 2026.