mHealth Behavior Study

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Condom Use; Alcohol Consumption

Treatments: Behavioral: Sham Training Group; Behavioral: Training Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06624514

Pro00138757

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Training Group

Experimental group

Description:

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).

Treatment:

Behavioral: Training Group

Control

Sham Comparator group

Description:

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

Treatment:

Behavioral: Sham Training Group