A Mindfulness-based Intervention for Sexual Assault Survivors

NCT07515586 | Not Yet Recruiting

• 2 other identifiers: H26093K01AA032045
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Mindfulness; Alcohol Misuse; Tobacco Use; Stress

Outcome Measures

Primary Outcomes (2)

• 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. 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).

  immediate post-test

Secondary Outcomes (1)

• Alcohol misuse assessed by Timeline Follow-Back Measuring Alcohol Consumption

  3 month follow-up

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Behavioral: mindfulness-based intervention

Study Arm 2

PLACEBO COMPARATOR

online resources on healthy eating and nutrition guidelines

Behavioral: comparison intervention

Interventions

mindfulness-based intervention BEHAVIORAL

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

Also known as: MindfulHeal

Arm 1

comparison intervention BEHAVIORAL

online resources on healthy eating and nutrition guidelines

Study Arm 2

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• not applicable

Sponsors & Collaborators

• Georgia State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anne Marie Schipani, PhD, MPH

  Georgia State University School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Marie Schipani, PhD, MPH

CONTACT

404-413-2339; aschipani@gsu.edu

Caitlin Thompson, MPH

CONTACT

cthompson150@gsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start (Estimated): October 4, 2027
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (1)