NCT07782398

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 17, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

just-in-time adaptive interventionmicro-randomized trialecological momentary assessmentwearable sensorhair cortisolemotional volatilitycollege students

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Within 2 hours after each randomized decision point, across weeks 2 to 5

Secondary Outcomes (10)

  • Momentary reactive online behavior since the previous check-in, self-reported occurrence

    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

    Within 2 hours after each randomized decision point, across weeks 2 to 5

  • Loss-of-control eating rating, score on a 7-point scale.

    Within 2 hours after each randomized decision point, across weeks 2 to 5

  • Proportion of scheduled check-ins completed.

    Through study completion, approximately 5 weeks per participant.

  • Proportion of delivered prompts receiving a response

    Through study completion, approximately 5 weeks per participant.

  • +5 more secondary outcomes

Other Outcomes (4)

  • Exploratory: concentration of hair cortisol, pg/mg.

    Enrollment visit, single hair sample reflecting approximately the prior 3 months.

  • Exploratory: concentration of hair testosterone, pg/mg.

    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.

    Baseline hair sample, with momentary outcomes across weeks 2 to 5.

  • +1 more other outcomes

Study Arms (2)

Coping prompt delivered

EXPERIMENTAL

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

No coping prompt or active control message

ACTIVE COMPARATOR

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

Interventions

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.

Coping prompt delivered

A brief neutral acknowledgment message matched to the coping messages on delivery mechanism and approximate length, containing no coping technique or behavioral suggestion.

No coping prompt or active control message

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Varsity student-athlete governed by the university athletic association
  • Unable to complete study procedures in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Emotional RegulationAlcohol Drinking in CollegeEmotional EatingAggression

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorAlcohol DrinkingDrinking BehaviorFeeding BehaviorAberrant Motor Behavior in DementiaBehavioral Symptoms

Study Officials

  • Yonghwan Chang, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghwan Chang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Micro-randomized trial. Each participant is repeatedly randomized at decision points across four weeks, so every participant contributes observations under both conditions rather than being assigned to a single group for the duration. At each available decision point, randomization with probability 0.5 determines whether a coping message is delivered; when a message is delivered, its type is selected at random from those eligible in that context. Approximately one hundred available randomized decision points are expected per participant. Crossover assignment is selected because it is the closest available model to a within-person repeated randomization design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations