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OpenTrials
Completed

NCT Number: NCT06624514

mHealth Behavior Study

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

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Key information

Conditions

Alcohol Consumption Alcohol Drinking Behavior Condom Use Drinking Behavior

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training group

Behavioral

Implicit approach bias is the behavioral action tendency to be faster to approach rather than avoid cues for a stimulus category. The Approach-Avoidance Task (AAT)is a computerized program in which participants make approach or avoidance movements in response to an irrelevant feature of an image presented on a computer screen (e.g., push when in portrait, pull when in landscape). The intervention in this study is a treatment version of the AAT used as an Approach Bias Modification (ABM) intervention, to retrain participants' implicit biases toward or away from stimuli by presenting the target stimuli predominantly in one format (e.g., push or pull).

Sham Training Group

Behavioral

A sham-training control condition

Primary outcomes

  1. Approach Bias

    Time frame: 3-months post final intervention session

    At one-week and three-months following the completion of the final study interventional session, participants will complete the AAT Assessment Procedure and complete the baseline questionnaire battery to assess alcohol and condom use since the previous appointment.

  2. Condom Use

    Time frame: Three-Months

    Condom use over the past three months will be measured via the NIDA HIV Risk Measure (HRM).

  3. Alcohol Use

    Time frame: Three-Months

    Alcohol use will be assessed at a three-month follow-up using the Daily Drinking Questionnaire - Revised (DDQ-R).

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Mobile Health Reaction Time and Behavior Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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