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Momentary Coping Prompts and Hair Steroids in College Students (REACT-Bio)

2026年8月25日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Yonghwan Chang, PhD
  • 电话号码:352-294-1664
  • 邮箱:yhchang@ufl.edu

学习地点

    • Florida
      • Gainesville、Florida、美国、32611
        • University of Florida
        • 接触:
        • 首席研究员:
          • Yonghwan Chang, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Momentary urge to post or reply reactively, score on a 7-point scale.
大体时间: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.
大体时间: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.
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Momentary reactive online behavior since the previous check-in, self-reported occurrence
大体时间: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
大体时间: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.
Within 2 hours after each randomized decision point, across weeks 2 to 5
Loss-of-control eating rating, score on a 7-point scale.
大体时间: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.
大体时间: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 delivered prompts receiving a response
大体时间: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 waking hours with valid wearable data.
大体时间: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.
Proportion of enrolled participants retained to study end.
大体时间: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.
Proportion of sub-study participants providing a usable hair sample.
大体时间:Enrollment visit
Number of usable hair samples divided by number of sub-study participants. Pre-registered benchmark is 90 percent.
Enrollment visit
Prompt helpfulness rating, score on a 7-point scale.
大体时间: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.
System Usability Scale total score
大体时间:End of study, approximately week 5.
System Usability Scale (Brooke, 1996) total score, range 0 to 100, higher scores indicating better usability.
End of study, approximately week 5.

其他结果措施

结果测量
措施说明
大体时间
Exploratory: concentration of hair cortisol, pg/mg.
大体时间:Enrollment visit, single hair sample reflecting approximately the prior 3 months.
Hair cortisol concentration in picograms per milligram assayed from a single hair sample. This measure is exploratory.
Enrollment visit, single hair sample reflecting approximately the prior 3 months.
Exploratory: concentration of hair testosterone, pg/mg.
大体时间:Enrollment visit, single hair sample reflecting approximately the prior 3 months.
Hair testosterone concentration in picograms per milligram assayed from a single hair sample. This measure is exploratory.
Enrollment visit, single hair sample reflecting approximately the prior 3 months.
Exploratory: correlation between hair cortisol concentration and momentary reactive behavior score, stratified by adverse childhood experiences score.
大体时间:Baseline hair sample, with momentary outcomes across weeks 2 to 5.
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.
Baseline hair sample, with momentary outcomes across weeks 2 to 5.
Exploratory: correlation between hair testosterone concentration and momentary reactive behavior score.
大体时间:Baseline hair sample, with momentary outcomes across weeks 2 to 5
Correlation between hair testosterone concentration (pg/mg) and momentary reactive behavior score (7-point scale). This measure is exploratory.
Baseline hair sample, with momentary outcomes across weeks 2 to 5

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yonghwan Chang, PhD、University of Florida

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年8月17日

首先提交符合 QC 标准的

2026年8月20日

首次发布 (实际的)

2026年8月24日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB202601059
  • 00135244 (其他赠款/资助编号:University of Florida Research Opportunity Seed Fund)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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