- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07789314
Just-in-Time Coping Prompts for Reactive Digital Behavior in College Students (REACT)
24. august 2026 oppdatert av: University of Florida
REACT: A Just-in-Time Adaptive Intervention to Reduce Reactive Digital Behavior in College Students
This study looks at the moments when college students feel a strong emotional swing, and how those moments relate to reacting online when upset, drinking alcohol, and eating in response to emotions.
Participants wear a wrist device and answer brief check-ins on their phone several times a day for about five weeks.
During part of that time, a study app sometimes sends a short coping message at moments when the wrist device and check-ins suggest emotions are shifting quickly.
Whether a message is sent at any given moment is decided at random, and the study compares what participants do in the short window afterward.
The study is a pilot designed to test whether the approach is feasible and to estimate how large its effects are.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
REACT is a five-week micro-randomized trial in University of Florida students age 18 and older.
Participants complete a baseline battery, wear a Garmin Venu 3, and respond to five to six smartphone check-ins per day.
Week one is a no-prompt run-in that establishes each participant's own baseline distribution of momentary affective variability, indexed by the mean square of successive differences on consecutive affect ratings.
From week two through week five, the app evaluates up to six decision points per day.
A decision point is flagged when the participant's current variability exceeds their own 80th percentile threshold, computed within person rather than against a group average.
At each available decision point the app randomizes with probability 0.5 whether to deliver a brief coping message, and if so selects a message type from those eligible in that context.
Availability rules exclude sleep, stale device data, a 60-minute cooldown, a daily cap, and any safety override.
Proximal outcomes are drawn from the first check-in within two hours after the decision point.
Analysis uses weighted and centered least squares to estimate causal excursion effects, with pre-specified moderators.
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yonghwan Chang, PhD
- Telefonnummer: 352-294-1664
- E-post: yhchang@ufl.edu
Studiesteder
-
-
Florida
-
Gainesville, Florida, Forente stater, 32611
- University of Florida
-
Ta kontakt med:
- Yonghwan Chang, PhD
- Telefonnummer: 352-294-1664
- E-post: yhchang@ufl.edu
-
Hovedetterforsker:
- Yonghwan Chang, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Currently enrolled University of Florida student
- Age 18 years or older
- Owns a smartphone used daily
- Willing to wear a wrist-worn device and complete brief check-ins several times daily for approximately five weeks
Exclusion Criteria:
- Varsity student-athlete governed by the university athletic association
- Unable to complete study procedures in English
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Coping prompt delivered
Decision points at which the randomization outcome is to deliver a brief cognitive-behavioral or acceptance-based coping message.
Message type is selected at random from those eligible in the participant's current context.
Every participant contributes decision points to this condition.
|
A single short message of one to three sentences delivered to the participant's smartphone at a randomized decision point, taking roughly fifteen to thirty seconds to read.
Messages apply cognitive-behavioral techniques including thought records, perspective-taking, decatastrophizing, cost-benefit checks, implementation intentions, and behavioral redirection, or acceptance-based techniques including cognitive defusion, acceptance, values anchoring, urge surfing, and present-moment grounding.
Delivery is capped at four messages per day with a minimum sixty-minute interval and is confined to participant-set waking hours.
Messages may be dismissed without responding.
|
|
Aktiv komparator: No coping prompt or active control message
Decision points at which the randomization outcome is not to deliver a coping message.
A brief neutral, non-directive acknowledgment message may be delivered as an active control so that receiving any message can be separated from receiving a coping message.
Every participant contributes decision points to this condition.
|
A brief neutral acknowledgment message matched to the coping messages on delivery mechanism and approximate length, containing no coping technique or behavioral suggestion.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Momentary urge to post or reply reactively, score on a 7-point scale.
Tidsramme: Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
Self-reported urge to post or reply about something upsetting, rated 1 to 7 at the first check-in within two hours after a randomized decision point.
Higher scores indicate greater urge.
Analyzed as a causal excursion effect comparing decision points at which a coping message was delivered with those at which it was not.
|
Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
|
Momentary urge to drink alcohol, score on a 7-point scale.
Tidsramme: Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
Self-reported current urge to drink alcohol, rated 1 to 7 at the first check-in within two hours after a randomized decision point.
Higher scores indicate greater urge.
Analyzed as a causal excursion effect.
|
Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
|
Momentary emotional influence on eating, score on a 7-point scale.
Tidsramme: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Self-reported rating of how much emotions influenced eating since the previous check-in, rated 1 to 7 at the first check-in within two hours after a randomized decision point.
Analyzed as a causal excursion effect.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of delivered prompts receiving a response
Tidsramme: Through study completion, approximately 5 weeks per participant.
|
Number of prompts receiving a rating response divided by number of prompts delivered.
Pre-registered benchmark is 60 percent.
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Through study completion, approximately 5 weeks per participant.
|
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Proportion of enrolled participants retained to study end.
Tidsramme: Through study completion, approximately 5 weeks per participant.
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Number of participants completing the study divided by number enrolled.
Pre-registered benchmark is 85 percent.
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Through study completion, approximately 5 weeks per participant.
|
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Momentary reactive online behavior since the previous check-in, self-reported occurrence
Tidsramme: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Self-reported occurrence of posting or replying while upset since the previous check-in, reported yes or no at the first check-in within two hours after a randomized decision point.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
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Number of standard drinks consumed since the previous check-in, self-reported count
Tidsramme: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Self-reported number of standard drinks consumed since the previous check-in.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
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Loss-of-control eating rating, score on a 7-point scale
Tidsramme: Within 2 hours after each randomized decision point, across weeks 2 to 5
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Self-reported sense of losing control while eating since the previous check-in, rated 1 to 7.
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Within 2 hours after each randomized decision point, across weeks 2 to 5
|
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Proportion of scheduled check-ins completed
Tidsramme: Through study completion, approximately 5 weeks per participant.
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Number of completed check-ins divided by number of scheduled check-ins.
Pre-registered feasibility benchmark is 75 percent.
|
Through study completion, approximately 5 weeks per participant.
|
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Proportion of waking hours with valid wearable data
Tidsramme: Through study completion, approximately 5 weeks per participant.
|
Hours of valid physiological data divided by estimated waking hours.
Pre-registered benchmark is 80 percent.
|
Through study completion, approximately 5 weeks per participant.
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Prompt helpfulness rating, score on a 7-point scale
Tidsramme: Week 3 and end of study, approximately week 5.
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Participant rating of how helpful the coping prompts were, rated 1 to 7.
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Week 3 and end of study, approximately week 5.
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System Usability Scale total score.
Tidsramme: End of study, approximately week 5.
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System Usability Scale (Brooke, 1996) total score, range 0 to 100, higher scores indicating better usability.
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End of study, approximately week 5.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Yonghwan Chang, PhD, University of Florida
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mai 2027
Studiet fullført (Antatt)
1. august 2027
Datoer for studieregistrering
Først innsendt
23. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
27. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB202600940
- 00135244 (Annet stipend/finansieringsnummer: University of Florida Research Opportunity Seed Fund)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared outside the research team.
This is a pilot study collecting sensitive behavioral and biological data from a small identifiable campus population, and the informed consent does not provide for external sharing of individual-level data.
Aggregate results will be published.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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