Momentary Coping Prompts and Hair Steroids in College Students
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Varsity student-athlete governed by the university athletic association
Unable to complete study procedures in English
Trial design
Design model
Crossover
Treatments tested in this trial
Momentary coping prompt
BehavioralA 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.
Active control message
BehavioralA brief neutral acknowledgment message matched to the coping messages on delivery mechanism and approximate length, containing no coping technique or behavioral suggestion.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Coping prompt deliveredExperimental treatment 1 intervention
Group B: No coping prompt or active control messageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 5.2
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 5.3
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 5Secondary outcomes
1
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 52
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 53
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 54
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.Other outcomes
1
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.2
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.3
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 5.4
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 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov