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Not yet recruiting NCT07515586

A Mindfulness-based Intervention for Sexual Assault Survivors

No phase Interventional Alcohol Misuse Tobacco Use Mindfulness Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mindfulness-based intervention, comparison intervention.
Who it may be relevant to
Registry conditions: Alcohol Misuse, Tobacco Use, Mindfulness, Stress. Basic parameters: 18 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Behavioral mindfulness-based intervention
    A mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use
  • Behavioral comparison intervention
    online resources on healthy eating and nutrition guidelines

Primary outcome measures

  • Recruitment and retention of 70% of the sample at 3-month follow-up [Time frame: 3 month follow-up]
  • Acceptability of the mindfulness-based intervention benchmark of 80% self-reported acceptability [Time frame: immediate post-test]
Secondary outcome measures (1)
  • Alcohol misuse assessed by Timeline Follow-Back Measuring Alcohol Consumption [Time frame: 3 month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Georgia State University — Atlanta

Identifiers

NCT: NCT07515586 · H26093 · K01AA032045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗