Keep Social Study for Young Adults

NCT07005817 | Enrolling By Invitation

• 2 other identifiers: 24-11841R01MD018492-01
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Social Isolation; Loneliness

Keywords

Keep Social; Online; Young Adult

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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).

  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.

  Week 6

Secondary Outcomes (15)

• Anxiety, Self-Report

  Baseline/Week 0, Week 2, Week 4, and Week 6

• Depression, Self-Report

  Baseline/Week 0, Week 2, Week 4, and Week 6

• Stress, Self-Report

  Baseline/Week 0, Week 2, Week 4, and Week 6

• Flourishing Mental Health, Self-Report

  Baseline/Week 0, Week 2, Week 4, and Week 6

• Life Satisfaction, Self-Report

  Baseline/Week 0, Week 2, Week 4, and Week 6

Study Arms (2)

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.

Behavioral: Experimental Health Communication

Placebo Control Arm

PLACEBO COMPARATOR

Participants are exposed to a simulated social media platform with background content.

Behavioral: Simulated Social Media Platform Only

Interventions

Experimental Health Communication BEHAVIORAL

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

Experimental Arm

Simulated Social Media Platform Only BEHAVIORAL

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

Placebo Control Arm

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Reside in rural region

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Barbara L. Frederickson, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 5, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• 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

Locations

US (1)