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mHealth Behavior Study

Mobile Health Reaction Time and Behavior Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06624514
Enrollment
46
Registered
2024-10-03
Start date
2025-01-29
Completion date
2026-02-09
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Consumption, Condom Use

Keywords

Alcohol, condoms, Sexual Assault, Risky Sex

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

Interventions

BEHAVIORALTraining 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).

BEHAVIORALSham Training Group

A sham-training control condition

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Approach Bias3-months post final intervention sessionAt 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 UseThree-MonthsCondom use over the past three months will be measured via the NIDA HIV Risk Measure (HRM).
Alcohol UseThree-MonthsAlcohol use will be assessed at a three-month follow-up using the Daily Drinking Questionnaire - Revised (DDQ-R).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAustin Hahn, PhD

Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026