Alcohol MisuseNCT07515586
A Mindfulness-based Intervention for Sexual Assault Survivors
A study testing mindfulness-based intervention and comparison intervention in people with Alcohol Misuse and Tobacco Use, run by Georgia State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Alcohol Misuse, Tobacco Use, Mindfulness
- What is being tested?
- mindfulness-based intervention and comparison intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2027to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- not applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Caitlin Thompson, MPH contact
United States1 site
Georgia State University
Atlanta, Georgia, 30303
Anne Marie Schipani, PhD, MPH, 404-413-2339, aschipani@gsu.edu
About this study
Official title: 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. 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?
Read more
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
- Alcohol Misuse, Tobacco Use, Mindfulness, Stress
- Being tested
- mindfulness-based intervention, comparison intervention
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based interventionBehavioural
Also called MindfulHeal
A mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use
comparison interventionBehavioural
online resources on healthy eating and nutrition guidelines
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | intervention 1 is a mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use Receives: Behavioral: mindfulness-based intervention |
| Study Arm 2 | Placebo comparator | online resources on healthy eating and nutrition guidelines Receives: Behavioral: comparison intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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
Measured: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start4 Oct 2027 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be a brief mindfulness-based intervention for college students focused on health, wellness, stress relief, and substance use.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Anne Marie Schipani-McLaughlin, Georgia State University
- Investigators
- Anne Marie Schipani, PhD, MPH, Principal investigator, Georgia State University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515586
- Sponsor's protocol ID
- H26093
- Other IDs
- K01AA032045
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Implementation Science to Develop a Mindfulness-Based Intervention to Reduce Alcohol Misuse and Tobacco Use Among Sexual Violence Survivors
- ClinicalTrials.gov ID
- NCT07515586
- Acronym / sponsor ID
- H26093
- Conditions
- Alcohol Misuse, Tobacco Use, Mindfulness, Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Oct 2027 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be a brief mindfulness-based intervention for college students focused on health, wellness, stress relief, and substance use.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: mindfulness-based interventionintervention 1 is a mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use |
| Study Arm 2 | Placebo comparator | Behavioral: comparison interventiononline resources on healthy eating and nutrition guidelines |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based interventionAlso: MindfulHealA mindfulness-based intervention that aims to reduce alcohol misuse and tobacco use | Behavioural | Arm 1 |
| comparison interventiononline resources on healthy eating and nutrition guidelines | Behavioural | Study Arm 2 |
Primary outcome
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
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).
1 secondary outcome
Alcohol misuse assessed by Timeline Follow-Back Measuring Alcohol Consumption
Time frame: 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin Thompson, MPH contact
Anne Marie Schipani, PhD, MPH principal investigator
Georgia State University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based intervention and comparison intervention in people with Alcohol Misuse and Tobacco Use, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Marie Schipani, PhD, MPH (404-413-2339, aschipani@gsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention of 70% of the sample at 3-month follow-up (time frame: 3 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.