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A Mindfulness-based Intervention for Sexual Assault Survivors

Leveraging Implementation Science to Develop a Mindfulness-Based Intervention to Reduce Alcohol Misuse and Tobacco Use Among Sexual Violence Survivors

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07515586
Enrollment
120
Registered
2026-04-07
Start date
2027-10-01
Completion date
2030-08-01
Last updated
2026-04-07

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

Conditions

Alcohol Misuse, Tobacco Use, Mindfulness, Stress

Brief summary

The goal is this pilot randomized trial is to learn if intervention 1 is feasible and acceptable. As a secondary goal, we aim to learn if intervention 1 reduces alcohol misuse and tobacco use in sexual assault survivors. The main questions it aims to answer are: * Is intervention 1 feasible to implement? * Is intervention 1 an acceptable intervention among the primary population, sexual assault survivors? * Does intervention 1 reduce alcohol misuse and tobacco use? Researchers will compare intervention 1 to an attention-placebo control group (e.g., online resources on healthy eating and nutrition). Participants will: * take online surveys at baseline, 1 month follow-up, and 3-month follow-up * answer text-message questions at baseline and post-test * view and engage in an educational program

Interventions

BEHAVIORALIntervention 1

A mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use

online resources on healthy eating and nutrition guidelines

Sponsors

Georgia State University
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The intervention will be a brief mindfulness-based intervention for college students focused on health, wellness, stress relief, and substance use.

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

* 18-24 years of age * currently enrolled as a full-time undergraduate at GSU * self-reported lifetime SV victimization * self-reported SV victimization in the past 6 months * drank alcohol within the last 30 days * must own a smartphone

Exclusion criteria

* not applicable

Design outcomes

Primary

MeasureTime frameDescription
Recruitment and retention of 70% of the sample at 3-month follow-up3 month follow-upFeasibility of the sample is assessed by recruitment and retention of at least 70% participants at 3 month follow-up
Acceptability of the mindfulness-based intervention benchmark of 80% self-reported acceptabilityimmediate post-testSelf-reported assessment of the following domains: quality, usefulness, relevancy, extent to which situations depicted are realistic, extent to which attitudes changed on alcohol and tobacco use, and managing stress

Secondary

MeasureTime frameDescription
Alcohol misuse assessed by Timeline Follow-Back Measuring Alcohol Consumption3 month follow-upa 10-item measure of alcohol use with .85 reliability

Countries

United States

Contacts

CONTACTAnne Marie Schipani, PhD, MPH
aschipani@gsu.edu404-413-2339
CONTACTCaitlin Thompson, MPH
cthompson150@gsu.edu
PRINCIPAL_INVESTIGATORAnne Marie Schipani, PhD, MPH

Georgia State University School of Public Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026