Momentary Coping Prompts and Hair Steroids in College Students (REACT-Bio)
25 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yonghwan Chang, PhD
- Número de teléfono: 352-294-1664
- Correo electrónico: yhchang@ufl.edu
Ubicaciones de estudio
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Florida
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Gainesville, Florida, Estados Unidos, 32611
- University of Florida
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Contacto:
- Yonghwan Chang, PhD
- Número de teléfono: 352-294-1664
- Correo electrónico: yhchang@ufl.edu
-
Investigador principal:
- Yonghwan Chang, PhD
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Momentary urge to post or reply reactively, score on a 7-point scale.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Momentary reactive online behavior since the previous check-in, self-reported occurrence
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exploratory: concentration of hair cortisol, pg/mg.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yonghwan Chang, PhD, University of Florida
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB202601059
- 00135244 (Otro número de subvención/financiamiento: University of Florida Research Opportunity Seed Fund)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .