mHealth Behavior Study

NCT06624514 | Completed

• 1 other identifier: Pro00138757
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Alcohol; condoms; Sexual Assault; Risky Sex

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Training Group

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Behavioral: Sham Training Group

Interventions

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).

Training Group

Sham Training Group BEHAVIORAL

A sham-training control condition

Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Participants will be 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Austin Hahn, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 3, 2024
• Study Start: January 29, 2025
• Primary Completion: February 9, 2026
• Study Completion: February 9, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)