mHealth Behavior Study

Not Applicable

Recruiting

• Conditions: Alcohol Consumption; Condom Use
• Interventions: Behavioral: Training Group; Behavioral: Sham Training Group

• Registration Number: NCT06624514
• Lead Sponsor: Medical University of South Carolina

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Study Start: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training Group	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).
Control	Sham Training Group	No treatment version of the AAT used as an Approach Bias Modification (ABM) intervention will be used in this group.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States