mHealth Behavior Study

Mobile Health Reaction Time and 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

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption; Condom Use
• Intervention / Treatment: Behavioral: Training Group; Behavioral: Sham Training Group

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training Group; This arm receives a 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).	Behavioral: Training Group; 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 Comparator: Control; No treatment version of the AAT used as an Approach Bias Modification (ABM) intervention will be used in this group.	Behavioral: Sham Training Group; A sham-training control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Approach Bias	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.	3-months post final intervention session
Condom Use	Condom use over the past three months will be measured via the NIDA HIV Risk Measure (HRM).	Three-Months
Alcohol Use	Alcohol use will be assessed at a three-month follow-up using the Daily Drinking Questionnaire - Revised (DDQ-R).	Three-Months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Austin Hahn, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2025
• Primary Completion (Actual): February 9, 2026
• Study Completion (Actual): February 9, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Alcohol; Sexual Assault; condoms; Risky Sex
• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Alcohol Drinking; Psychotherapy; Behavioral Disciplines and Activities; Socioenvironmental Therapy; Psychotherapy, Group; Sensitivity Training Groups
• Other Study ID Numbers: Pro00138757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No