mHealth Behavior Study

NCT ID: NCT06624514

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2026-02-28

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

Conditions

Alcohol Consumption; Condom Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Training Group

Intervention Type: 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).

Control

No treatment version of the AAT used as an Approach Bias Modification (ABM) intervention will be used in this group.

Group Type: SHAM_COMPARATOR

Sham Training Group

Intervention Type: BEHAVIORAL

A sham-training control condition

Interventions

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).

Intervention Type: BEHAVIORAL

Sham Training Group

A sham-training control condition

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Austin Hahn, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Boatright

Role: CONTACT

boatrigh@musc.edu

843-779-2552

Facility Contacts

Amy Boatright

Role: primary

boatrigh@musc.edu

843-779-2552

Role: backup

boatrigh@musc.edu

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00138757

Identifier Type: -

Identifier Source: org_study_id