- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07789314
Just-in-Time Coping Prompts for Reactive Digital Behavior in College Students (REACT)
24 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
80
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Yonghwan Chang, PhD
- Numero di telefono: 352-294-1664
- Email: yhchang@ufl.edu
Luoghi di studio
-
-
Florida
-
Gainesville, Florida, Stati Uniti, 32611
- University of Florida
-
Contatto:
- Yonghwan Chang, PhD
- Numero di telefono: 352-294-1664
- Email: yhchang@ufl.edu
-
Investigatore principale:
- Yonghwan Chang, PhD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Momentary urge to post or reply reactively, score on a 7-point scale.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
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.
|
Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of delivered prompts receiving a response
Lasso di tempo: 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.
|
Through study completion, approximately 5 weeks per participant.
|
|
Proportion of enrolled participants retained to study end.
Lasso di tempo: Through study completion, approximately 5 weeks per participant.
|
Number of participants completing the study divided by number enrolled.
Pre-registered benchmark is 85 percent.
|
Through study completion, approximately 5 weeks per participant.
|
|
Momentary reactive online behavior since the previous check-in, self-reported occurrence
Lasso di tempo: Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
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.
|
Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
|
Number of standard drinks consumed since the previous check-in, self-reported count
Lasso di tempo: Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
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.
|
|
Loss-of-control eating rating, score on a 7-point scale
Lasso di tempo: Within 2 hours after each randomized decision point, across weeks 2 to 5
|
Self-reported sense of losing control while eating since the previous check-in, rated 1 to 7.
|
Within 2 hours after each randomized decision point, across weeks 2 to 5
|
|
Proportion of scheduled check-ins completed
Lasso di tempo: Through study completion, approximately 5 weeks per participant.
|
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.
|
|
Proportion of waking hours with valid wearable data
Lasso di tempo: 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.
|
|
Prompt helpfulness rating, score on a 7-point scale
Lasso di tempo: Week 3 and end of study, approximately week 5.
|
Participant rating of how helpful the coping prompts were, rated 1 to 7.
|
Week 3 and end of study, approximately week 5.
|
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System Usability Scale total score.
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Yonghwan Chang, PhD, University of Florida
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 maggio 2027
Completamento dello studio (Stimato)
1 agosto 2027
Date di iscrizione allo studio
Primo inviato
23 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
24 agosto 2026
Primo Inserito (Effettivo)
27 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB202600940
- 00135244 (Altro numero di sovvenzione/finanziamento: University of Florida Research Opportunity Seed Fund)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .