An interventional study of Momentary coping prompt and Active control message in Emotional Regulation, Alcohol Drinking in College and Emotional Eating, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
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 five weeks in total, starting with a 1-week run-in. During the following 4 weeks, a study app sometimes sends a short coping message at moments when check-in answers 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.
REACT is a five-week micro-randomized trial in University of Florida students age 18 to 24. 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.
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 80 is close to the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 5, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Momentary coping prompt
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.
Behavioral: Active control message
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.
A brief neutral acknowledgment message matched to the coping messages on delivery mechanism and approximate length, containing no coping technique or behavioral suggestion.
Momentary urge to post or reply reactively, score on a 7-point scale.
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.
Time frame: Within 2 hours after each randomized decision point, across weeks 2 to 5.
Momentary urge to drink alcohol, score on a 7-point scale.
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.
Time frame: Within 2 hours after each randomized decision point, across weeks 2 to 5.
Momentary emotional influence on eating, score on a 7-point scale.
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.
Time frame: Within 2 hours after each randomized decision point, across weeks 2 to 5
Momentary reactive online behavior since the previous check-in, self-reported occurrence
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.
Time frame: 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
Self-reported number of standard drinks consumed since the previous check-in.
Time frame: Within 2 hours after each randomized decision point, across weeks 2 to 5
Loss-of-control eating rating, score on a 7-point scale.
Self-reported sense of losing control while eating since the previous check-in, rated 1 to 7.
Time frame: Within 2 hours after each randomized decision point, across weeks 2 to 5
Proportion of scheduled check-ins completed.
Number of completed check-ins divided by number of scheduled check-ins. Pre-registered feasibility benchmark is 75 percent.
Time frame: Through study completion, approximately 5 weeks per participant.
Proportion of delivered prompts receiving a response
Number of prompts receiving a rating response divided by number of prompts delivered. Pre-registered benchmark is 60 percent.
Time frame: Through study completion, approximately 5 weeks per participant.
Proportion of waking hours with valid wearable data.
Hours of valid physiological data divided by estimated waking hours. Pre-registered benchmark is 80 percent.
Time frame: Through study completion, approximately 5 weeks per participant.
Proportion of enrolled participants retained to study end.
Number of participants completing the study divided by number enrolled. Pre-registered benchmark is 85 percent.
Time frame: Through study completion, approximately 5 weeks per participant.
Proportion of sub-study participants providing a usable hair sample.
Number of usable hair samples divided by number of sub-study participants. Pre-registered benchmark is 90 percent.
Time frame: Enrollment visit
Prompt helpfulness rating, score on a 7-point scale.
Participant rating of how helpful the coping prompts were, rated 1 to 7.
Time frame: Week 3 and end of study, approximately week 5.
System Usability Scale total score
System Usability Scale (Brooke, 1996) total score, range 0 to 100, higher scores indicating better usability.
Time frame: End of study, approximately week 5.
Exploratory: concentration of hair cortisol, pg/mg.
Hair cortisol concentration in picograms per milligram assayed from a single hair sample. This measure is exploratory.
Time frame: Enrollment visit, single hair sample reflecting approximately the prior 3 months.
Exploratory: concentration of hair testosterone, pg/mg.
Hair testosterone concentration in picograms per milligram assayed from a single hair sample. This measure is exploratory.
Time frame: 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.
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.
Time frame: Baseline hair sample, with momentary outcomes across weeks 2 to 5.
Exploratory: correlation between hair testosterone concentration and momentary reactive behavior score.
Correlation between hair testosterone concentration (pg/mg) and momentary reactive behavior score (7-point scale). This measure is exploratory.
Time frame: Baseline hair sample, with momentary outcomes across weeks 2 to 5
Exploratory: eating when not hungry, self-reported occurrence
Whether the participant reported eating since the previous check-in after rating their hunger just before eating at 3 or lower on a 1 to 7 scale, recorded at the outcome check-in after a randomized decision point and analyzed as a causal excursion effect. Collected only from participants who agreed to the Amendment 1 check-in items.
Time frame: 60 to 120 minutes after each randomized decision point, across weeks 2 to 5
Exploratory: loss of control while eating, self-reported occurrence
Whether the participant rated loss of control over eating, or feeling unable to stop once started, at 3 or higher on a 1 to 5 scale for an eating episode since the previous check-in, recorded at the outcome check-in after a randomized decision point. Collected only from participants who agreed to the Amendment 1 check-in items.
Time frame: 60 to 120 minutes after each randomized decision point, across weeks 2 to 5
Exploratory: eating highly palatable foods, self-reported occurrence
Whether an eating episode since the previous check-in included sweets or desserts, salty snacks, fast food or sugary drinks, recorded at the outcome check-in after a randomized decision point. Collected only from participants who agreed to the Amendment 1 check-in items.
Time frame: 60 to 120 minutes after each randomized decision point, across weeks 2 to 5
Exploratory: emotional eating, self-reported occurrence
Whether the participant rated eating because of how they were feeling at 3 or higher on a 1 to 5 scale for an eating episode since the previous check-in, recorded at the outcome check-in after a randomized decision point. Collected only from participants who agreed to the Amendment 1 check-in items.
Time frame: 60 to 120 minutes after each randomized decision point, across weeks 2 to 5
Exploratory: momentary desire to eat something tasty, score on a 7-point scale
Current desire to eat something tasty, rated 1 to 7 at the outcome check-in after a randomized decision point. Higher scores indicate stronger desire. Collected only from participants who agreed to the Amendment 1 check-in items.
Time frame: 60 to 120 minutes after each randomized decision point, across weeks 2 to 5
Exploratory: change in eating disorder symptoms, EDE-QS total score
Eating Disorder Examination Questionnaire Short (EDE-QS), 12 items, total score 0 to 36, higher scores indicating more eating disorder symptoms. Change from baseline to end of study. Added under Amendment 1.
Time frame: Baseline and end of study, approximately week 5
Exploratory: change in insomnia severity, Insomnia Severity Index total score
Insomnia Severity Index, 7 items, total score 0 to 28, higher scores indicating more severe insomnia. Change from baseline to end of study. Added under Amendment 1.
Time frame: Baseline and end of study, approximately week 5
Exploratory: change in anxiety symptoms, GAD-7 total score
Generalized Anxiety Disorder 7-item scale, total score 0 to 21, higher scores indicating more anxiety. Change from baseline to end of study. Added under Amendment 1.
Time frame: Baseline and end of study, approximately week 5
Exploratory: change in mental wellbeing, SWEMWBS score
Short Warwick-Edinburgh Mental Wellbeing Scale, 7 items, raw score 7 to 35, higher scores indicating better wellbeing. Change from baseline to end of study. Added under Amendment 1.
Time frame: Baseline and end of study, approximately week 5
Exploratory: change in perceived stress, PSS-10 total score
Perceived Stress Scale, 10 items, total score 0 to 40, higher scores indicating more perceived stress. Change from baseline to end of study; the end-of-study assessment was added under Amendment 1.
Time frame: Baseline and end of study, approximately week 5
Plan to share: Yes — De-identified data from participants who agree to data sharing on the consent form, a separate choice that does not affect participation or payment. The deposit holds survey and check-in responses, app timing records, wearable sensor data and hair assay values. Before deposit we remove names, contact information, email and IP addresses, device serial numbers, free-text answers and interview recordings, convert calendar dates to study days, and replace each study code with a new random number. The key linking study codes to identities stays at the University of Florida and is never shared. No hair or other specimens are banked.
Time frame: After the main results are published. ICPSR keeps the files indefinitely. A participant may withdraw the choice at any time before deposit.
Access criteria: Restricted-use files at the Inter-university Consortium for Political and Social Research (ICPSR), University of Michigan, released only to researchers who sign its data use agreement, which forbids any attempt to identify participants.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for May 2027, 8 months after the start.
Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 8 months is below that.
Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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