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Not yet recruitingNCT07515586Updated Jul 16, 2026

A Mindfulness-based Intervention for Sexual Assault Survivors

An interventional study of mindfulness-based intervention and comparison intervention in Alcohol Misuse, Tobacco Use and Mindfulness, sponsored by Georgia State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Georgia State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study summary

The goal is this pilot randomized trial is to learn if intervention 1 is feasible and acceptable. A secondary aim is 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
02

Conditions studied

  • Alcohol Misuse
  • Tobacco Use
  • Mindfulness
  • Stress

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03

In context

Tobacco Use

125 studies on the registry are indexed under Tobacco Use; 64 are open to participants now.

This study's planned enrollment of 120 is below the median of 150 across 119 interventional studies indexed under Tobacco Use.

Browse Tobacco Use studies →

Lead sponsor

Georgia State University is the lead sponsor of 52 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • not applicable
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Arm 1

    intervention 1 is a mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use

    Behavioral: mindfulness-based intervention

  • Placebo comparator
    Study Arm 2

    online resources on healthy eating and nutrition guidelines

    Behavioral: comparison intervention

Interventions

  • Behavioralmindfulness-based intervention

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

    Also known as: MindfulHeal

  • Behavioralcomparison intervention

    online resources on healthy eating and nutrition guidelines

06

What researchers measure

Primary outcomes

  1. Recruitment and retention of 70% of the sample at 3-month follow-up

    Feasibility of the sample is assessed by recruitment and retention of at least 70% participants at 3 month follow-up

    Time frame: 3 month follow-up

  2. Acceptability of the mindfulness-based intervention benchmark of 80% self-reported acceptability

    Self-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. Higher scores indicate higher perceived acceptability of the intervention in the indicated domains (e.g., quality, usefulness, relevancy, extent to which situations depicted are realistic, extent to which attitudes changed on alcohol and tobacco use, and managing stress).

    Time frame: immediate post-test

Secondary outcomes

  1. Alcohol misuse assessed by Timeline Follow-Back Measuring Alcohol Consumption

    a 10-item measure of alcohol use with .85 reliability

    Time frame: 3 month follow-up

07

Study locations

1 site
  • Georgia State University
    Atlanta, Georgia 30303, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07515586
Lead sponsor
Georgia State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Anne Marie Schipani-McLaughlin (Assistant Professor, Georgia State University) — Principal investigator
First posted
Apr 7, 2026
Start date
Oct 4, 2027 (estimated)
Primary completion
Mar 30, 2029 (estimated)
Completion
Mar 30, 2029 (estimated)
Last update
Jul 16, 2026

Study contacts

Anne Marie Schipani, PhD, MPH
Contact
aschipani@gsu.edu
404-413-2339
Caitlin Thompson, MPH
Contact
cthompson150@gsu.edu
Anne Marie Schipani, PhD, MPH
principal investigator · Georgia State University School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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