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NCT Number: NCT07515586

A Mindfulness-based Intervention for Sexual Assault Survivors

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

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Key information

Conditions

Alcohol Misuse Behavior Mindfulness Stress Tobacco Use

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30303, United States

Location contact

Anne Marie Schipani, PhD, MPH

CONTACT

[email protected]

404-413-2339

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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

Other names: MindfulHeal

comparison intervention

Behavioral

online resources on healthy eating and nutrition guidelines

Primary outcomes

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

    Time frame: 3 month follow-up

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

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

    Time frame: immediate post-test

    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).

Secondary outcomes

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

    Time frame: 3 month follow-up

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Marie Schipani, PhD, MPH

CONTACT

[email protected]

404-413-2339

Caitlin Thompson, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Apr 7, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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