Momentary Coping Prompts and Hair Steroids in College Students (REACT-Bio)
25 août 2026 mis à jour par: University of Florida
REACT Biomarker and Extended-Measures Study: Hair Steroids, Psychosocial Moderators, and Momentary Reactive 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.
An optional part of the study collects one small hair sample, which is tested for two hormones related to stress and to status-linked behavior, so the researchers can see whether longer-term hormone levels relate to how people respond in the moment.
The study is a pilot designed to test whether the approach works and to estimate how large its effects are.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
An optional sub-study collects a single hair sample at the enrollment visit, assayed for cortisol and testosterone, to test whether early-life adversity moderates the association between chronic stress physiology and momentary reactive behavior.
Type d'étude
Interventionnel
Inscription (Estimé)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yonghwan Chang, PhD
- Numéro de téléphone: 352-294-1664
- E-mail: yhchang@ufl.edu
Lieux d'étude
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Florida
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Gainesville, Florida, États-Unis, 32611
- University of Florida
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Contact:
- Yonghwan Chang, PhD
- Numéro de téléphone: 352-294-1664
- E-mail: yhchang@ufl.edu
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Chercheur principal:
- Yonghwan Chang, PhD
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
- For the optional hair biomarker sub-study only: at least approximately 1 cm of hair at the posterior vertex, no scalp wound, rash, or dermatologic treatment at the collection site, and natural hair growth accessible at the collection site
Exclusion Criteria:
- Varsity student-athlete governed by the university athletic association
- Unable to complete study procedures in English
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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.
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Comparateur actif: 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.
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A brief neutral acknowledgment message matched to the coping messages on delivery mechanism and approximate length, containing no coping technique or behavioral suggestion.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Momentary urge to post or reply reactively, score on a 7-point scale.
Délai: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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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.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Momentary urge to drink alcohol, score on a 7-point scale.
Délai: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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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.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Momentary emotional influence on eating, score on a 7-point scale.
Délai: 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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Momentary reactive online behavior since the previous check-in, self-reported occurrence
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
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Through study completion, approximately 5 weeks per participant.
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Proportion of delivered prompts receiving a response
Délai: Through study completion, approximately 5 weeks per participant.
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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 waking hours with valid wearable data.
Délai: Through study completion, approximately 5 weeks per participant.
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Hours of valid physiological data divided by estimated waking hours.
Pre-registered benchmark is 80 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.
Délai: 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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Proportion of sub-study participants providing a usable hair sample.
Délai: Enrollment visit
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Number of usable hair samples divided by number of sub-study participants.
Pre-registered benchmark is 90 percent.
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Enrollment visit
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Prompt helpfulness rating, score on a 7-point scale.
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Exploratory: concentration of hair cortisol, pg/mg.
Délai: Enrollment visit, single hair sample reflecting approximately the prior 3 months.
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Hair cortisol concentration in picograms per milligram assayed from a single hair sample.
This measure is exploratory.
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Enrollment visit, single hair sample reflecting approximately the prior 3 months.
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Exploratory: concentration of hair testosterone, pg/mg.
Délai: Enrollment visit, single hair sample reflecting approximately the prior 3 months.
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Hair testosterone concentration in picograms per milligram assayed from a single hair sample.
This measure is exploratory.
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Enrollment visit, single hair sample reflecting approximately the prior 3 months.
|
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Exploratory: correlation between hair cortisol concentration and momentary reactive behavior score, stratified by adverse childhood experiences score.
Délai: Baseline hair sample, with momentary outcomes across weeks 2 to 5.
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Correlation between hair cortisol concentration (pg/mg) and momentary reactive behavior score (7-point scale), examined separately by adverse childhood experiences score measured with the ACE questionnaire (range 0 to 10).
This measure is exploratory.
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Baseline hair sample, with momentary outcomes across weeks 2 to 5.
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Exploratory: correlation between hair testosterone concentration and momentary reactive behavior score.
Délai: Baseline hair sample, with momentary outcomes across weeks 2 to 5
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Correlation between hair testosterone concentration (pg/mg) and momentary reactive behavior score (7-point scale).
This measure is exploratory.
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Baseline hair sample, with momentary outcomes across weeks 2 to 5
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Yonghwan Chang, PhD, University of Florida
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 mai 2027
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
17 août 2026
Première soumission répondant aux critères de contrôle qualité
20 août 2026
Première publication (Réel)
24 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB202601059
- 00135244 (Autre subvention/numéro de financement: University of Florida Research Opportunity Seed Fund)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .