CompletedNot Applicable

mHealth Behavior Study

United States46 participantsStarted 2025-01-29

Plain-language summary

The goal of this clinical trial is to learn if a brief task completed on a smartphone can reduce alcohol use and risky sexual behavior among women between the ages of 18 and 25 who have a history of experiencing sexual assault or an unwanted sexual experience. The main questions it aims to answer are: * Does the smartphone task change approach biases for alcohol and condom-related images? * Does the smartphone task reduce alcohol use and risky sexual behavior? Researchers will compare the smartphone task to a sham control to see if the smartphone task changes biases and behavior. Participants will: * Complete a baseline assessment battery of questionnaires * Complete either the intervention smartphone task or the sham smartphone task on four consecutive days. * Complete a follow-up assessment one week after finishing the four tasks * Complete a three-month follow-up

Who can participate

Age range

18 Years – 25 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult women who report lifetime experience sexual assault, * Consume alcohol at least moderately (e.g., at least seven drinks per week; NIAAA, 2015), * Have engaged in sexual intercourse with a casual, non-committed male partner without a condom at least three times during the three months prior to data collection. Exclusion Criteria: * Active homicidal or suicidal ideation; * History of or current psychotic disorders as the study protocol may be therapeutically insufficient; * Previously identified as having a Pervasive Developmental Disability.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Approach Bias

Timeframe: 3-months post final intervention session

Condom Use

Timeframe: Three-Months

Alcohol Use

Timeframe: Three-Months

Trial details

NCT IDNCT06624514

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-09

View on ClinicalTrials.gov More Alcohol Consumption trials