Momentary Coping Prompts and Hair Steroids in College Students (REACT-Bio)
25. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
80
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Yonghwan Chang, PhD
- Telefonní číslo: 352-294-1664
- E-mail: yhchang@ufl.edu
Studijní místa
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Florida
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Gainesville, Florida, Spojené státy, 32611
- University of Florida
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Kontakt:
- Yonghwan Chang, PhD
- Telefonní číslo: 352-294-1664
- E-mail: yhchang@ufl.edu
-
Vrchní vyšetřovatel:
- Yonghwan Chang, PhD
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Momentary urge to post or reply reactively, score on a 7-point scale.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Momentary reactive online behavior since the previous check-in, self-reported occurrence
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Exploratory: concentration of hair cortisol, pg/mg.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Yonghwan Chang, PhD, University of Florida
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. září 2026
Primární dokončení (Odhadovaný)
1. května 2027
Dokončení studie (Odhadovaný)
1. prosince 2027
Termíny zápisu do studia
První předloženo
17. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
20. srpna 2026
První zveřejněno (Aktuální)
24. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
28. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB202601059
- 00135244 (Jiné číslo grantu/financování: University of Florida Research Opportunity Seed Fund)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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