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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Tobacco Use; Alcohol Misuse; Mindfulness
• Intervention / Treatment: Behavioral: Intervention 1; Behavioral: comparison intervention

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Marie Schipani, PhD, MPH; Phone Number: 404-413-2339; Email: aschipani@gsu.edu
• Study Contact Backup: Name: Caitlin Thompson, MPH; Email: cthompson150@gsu.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Georgia State University
      • Contact: Anne Marie Schipani, PhD, MPH; Phone Number: 404-413-2339; Email: aschipani@gsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; intervention 1 is a mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use	Behavioral: Intervention 1; A mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use; Other Names: MindfulHeal
Placebo Comparator: Study Arm 2; online resources on healthy eating and nutrition guidelines	Behavioral: comparison intervention; online resources on healthy eating and nutrition guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 month follow-up
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	immediate post-test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol misuse assessed by Timeline Follow-Back Measuring Alcohol Consumption	a 10-item measure of alcohol use with .85 reliability	3 month follow-up

Collaborators and Investigators

• Sponsor: Georgia State University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Anne Marie Schipani, PhD, MPH, Georgia State University School of Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Tobacco Use
• Other Study ID Numbers: H26093; K01AA032045 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No