Health TrialsbyHealthPanel

A Mindfulness-based Intervention for Sexual Assault Survivors

ConditionsAlcohol MisuseTobacco UseMindfulnessStress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-24
SponsorGeorgia State University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

not applicable

Trial design

Design model

Parallel

Treatments tested in this trial

  • mindfulness-based intervention

    Behavioral

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

  • comparison intervention

    Behavioral

    online resources on healthy eating and nutrition guidelines

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Study Arm 2Placebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgia State University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: