Alcohol MisuseVR for MINCT07902154
Using Virtual Reality to Augment Brief Interventions for Heavy Drinking Young Adults
A study testing Virtual Reality experience and Brief motivational intervention in people with Alcohol Misuse, run by Brown University.
Trial summary
The overarching goal of this research is to explore whether VR might be used to augment brief motivational interviewing (BMI) techniques among heavy drinking young adults (age 18-34) and to test the preliminary efficacy of the VR experience when used within the BMI workflow of a typical counseling session. Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Alcohol Misuse
- What is being tested?
- Virtual Reality experience and Brief motivational intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jun 2030
- 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 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-34 years old
- Report hazardous alcohol use in the past month, as defined by NIAAA guidelines as having had 5 or more drinks on a single occasion for men or 4 or more drinks for women, OR an average of 14 or more drinks in an average week for men or 7 or more drinks on an average week for women
- Speak and read English fluently
- Have been referred to the University of Alabama's Collegiate Recovery and Intervention Services (CRIS) for intervention after having received an alcohol-related infraction, injury, arrest, or other problem.
Who cannot join
- Being at risk for or having a history of complicated alcohol withdrawal, as defined by having a seizure or seeing, hearing, or feeling things that were not really there at a time when they stopped, cut down, or went without drinking
- Currently receiving treatment for any substance use disorder outside of CRIS
- Screening positive for another drug use disorder, as assessed by a score of 3 or more on the Drug Abuse Screening Test
- Have severe mental illness, defined by currently being under the care of a mental health professional for schizophrenia, bipolar disorder, severe depression, or another serious mental health condition
- Having a history of significant motion sickness, as defined by a total score of 10 or more on the Simulator Sickness Questionnaire
- Having a history of seizures or a diagnosis of epilepsy or other seizure disorder
- Having been told by a doctor or other healthcare professional that they should not use devices with bright lights or a lot of visual motion, such as video games, virtual reality glasses, or certain movies, for health-related reasons
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The overarching goal of this research is to explore whether VR might be used to augment brief motivational interviewing (BMI) techniques among heavy drinking young adults (age 18-34) and to test the preliminary efficacy of the VR experience when used within the BMI workflow of a typical counseling session.
- Conditions
- Alcohol Misuse
- Being tested
- Virtual Reality experience, Brief motivational intervention
- Keywords
- virtual reality, alcohol misuse, alcohol problems, brief interventions, counseling
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality experienceDevice
The Fresh Start VR experience is intended to help clients reflect on important life priorities and goals and whether their current drinking patterns help facilitate or are an obstacle to those goals.
Brief motivational interventionBehavioural
Brief motivational intervention is a standard, two-session brief motivational intervention that will involve personalized normative feedback, techniques intended to help explore and resolve ambivalence about drinking, and potential options for change. Each session will last approximately 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Brief motivational intervention | Active comparator | All participants will receive a standard, two-session brief motivational intervention that will involve personalized normative feedback, techniques intended to help explore and resolve ambivalence about drinking, and potential options for change. Each session will last approximately 60 minutes. Receives: Behavioral: Brief motivational intervention |
| Brief motivational intervention plus the Fresh Start VR experience | Experimental | Participants assigned to this condition will receive the same standard two-session brief motivational intervention as in the control group, except the counselor will offer clients the opportunity to use the Fresh Start VR experience as one way of helping them explore and resolve their ambivalence about their drinking. Receives: Device: Virtual Reality experience; Behavioral: Brief motivational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption: percentage of participants who agree to use VR when offered in counseling
Adoption of VR will be assessed by calculating the percentage of participants assigned to the VR condition who agree to use VR when offered by a counselor during a counseling session.
Measured: During the intervention session (at Baseline)
Tolerability: percentage of participants who discontinue VR after starting
Tolerability will be assessed by calculating the percentage of participants assigned to the VR condition who discontinue using VR after starting to use it.
Measured: During the intervention session (at Baseline)
Feasibility: total score on the Feasibility of Intervention Measure
Feasibility of using VR within brief alcohol counseling sessions will be assessed using the Feasibility of Intervention Measure, a 4-item measure that assesses items such as "Using VR in counseling sessions seems doable." Each item is assessed on a 5-point scale from 1 (completely disagree) to 5 (completely agree). Each participant's total score on the FIM will serve as the primary outcome and will be compared across groups.
Measured: Immediately following the intervention session (at Baseline)
Acceptability: total score on the Acceptability of Intervention Measure
Acceptability of using VR within brief alcohol counseling sessions will be assessed using the Acceptability of Intervention Measure (AIM), a 4-item measure that assesses items such as "Using VR in counseling sessions is appealing to me." Each item is assessed on a 5-point scale from 1 (completely disagree) to 5 (completely agree). Each participant's total score on the AIM will serve as the primary outcome and will be compared across groups.
Measured: Immediately following the intervention session (at Baseline)
Satisfaction: total score on the Client Satisfaction Scale 8 (CSQ-8)
Satisfaction with counseling will be assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item measure that assesses items such as "How would you rate the quality of service you have received?" Each item is rated on a 4-point scale, but the response options vary by item (e.g., item 1 ranges from 1 [poor] to 4 [excellent]). Each participant's total score on the CSQ-8 will serve as the primary outcome and will be compared across groups.
Measured: Immediately following the intervention session (at Baseline)
Secondary outcomes (3)
Average drinks per drinking day: The average number of drinks consumed per drinking day over the previous 28 days, as assessed by online Timeline Followback (TLFB) assessment
An online version of the Timeline Followback will assess drinking days and the number of standard drinks consumed each day over the previous 28 days at baseline, and months 1, 2, 3, and 6 after baseline. At each follow-up, the average number of drinks participants consumed on occasions when they drank will be calculated and compared across groups.
Measured: Baseline, 1 month, 2 months, 3 months, and 6 months
Heavy episodic drinking days: Total number of days on which participants reported drinking 4+ drinks (for women) or 5+ drinks (for men) over the previous 28 days, as assessed by online Timeline Followback (TLFB) assessment
An online version of the Timeline Followback will assess drinking days and the number of standard drinks consumed each day over the previous 28 days at baseline, and months 1, 2, 3, and 6 after baseline. At each follow-up, we will calculate the total number of days on which participants reported drinking 4+ drinks (for women) or 5+ drinks (for men) on a single day and compare them across groups.
Measured: Baseline, 1 month, 2 months, 3 months, and 6 months
Alcohol-related problems: Total number of alcohol-related problems in the past 28 days as assessed by the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
Alcohol-related consequences will be assessed using the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ), a 24-item measure that assesses items such as "I have had a hangover (headache, sick stomach) the morning after I had been drinking." Each item is assessed as 0 (no) or 1 (yes). Each participant's total count of problems reported will be compared across groups.
Measured: Baseline, 1 month, 2 months, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionJun 2030 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Tyler Wray, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902154
- Sponsor's protocol ID
- STUDY00001250
- Other IDs
- R01AA031282
- Acronym
- VR for MI
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on key outcomes, including both primary outcomes (adoption, tolerability, feasibility, acceptability) and secondary, preliminary efficacy outcomes (average drinks per drinking days, total count of heavy episodic days, and total count of alcohol-related problems) will be shared with the NIAAA Data Archive, in alignment with NIH and NIAAA policy. Only data from participants who specifically consent to having their data archived during the informed consent process will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality to Augment Brief Interventions for Heavy Drinking Young Adults
- ClinicalTrials.gov ID
- NCT07902154
- Acronym / sponsor ID
- VR for MI / STUDY00001250
- Conditions
- Alcohol Misuse
- Keywords
- virtual reality, alcohol misuse, alcohol problems, brief interventions, counseling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 28 Oct 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 overarching goal of this research is to explore whether VR might be used to augment brief motivational interviewing (BMI) techniques among heavy drinking young adults (age 18-34) and to test the preliminary efficacy of the VR experience when used within the BMI workflow of a typical counseling session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief motivational intervention | Active comparator | Behavioral: Brief motivational interventionAll participants will receive a standard, two-session brief motivational intervention that will involve personalized normative feedback, techniques intended to help explore and resolve ambivalence about drinking, and potential options for change. Each session will last approximately 60 minutes. |
| Brief motivational intervention plus the Fresh Start VR experience | Experimental | Device: Virtual Reality experience, Behavioral: Brief motivational interventionParticipants assigned to this condition will receive the same standard two-session brief motivational intervention as in the control group, except the counselor will offer clients the opportunity to use the Fresh Start VR experience as one way of helping them explore and resolve their ambivalence about their drinking. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-34 years old
- Report hazardous alcohol use in the past month, as defined by NIAAA guidelines as having had 5 or more drinks on a single occasion for men or 4 or more drinks for women, OR an average of 14 or more drinks in an average week for men or 7 or more drinks on an average week for women
- Speak and read English fluently
- Have been referred to the University of Alabama's Collegiate Recovery and Intervention Services (CRIS) for intervention after having received an alcohol-related infraction, injury, arrest, or other problem.
Key exclusion criteria (7 listed)
- Being at risk for or having a history of complicated alcohol withdrawal, as defined by having a seizure or seeing, hearing, or feeling things that were not really there at a time when they stopped, cut down, or went without drinking
- Currently receiving treatment for any substance use disorder outside of CRIS
- Screening positive for another drug use disorder, as assessed by a score of 3 or more on the Drug Abuse Screening Test
- Have severe mental illness, defined by currently being under the care of a mental health professional for schizophrenia, bipolar disorder, severe depression, or another serious mental health condition
- Having a history of significant motion sickness, as defined by a total score of 10 or more on the Simulator Sickness Questionnaire
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 |
|---|---|---|
| Virtual Reality experienceThe Fresh Start VR experience is intended to help clients reflect on important life priorities and goals and whether their current drinking patterns help facilitate or are an obstacle to those goals. | Device | Brief motivational intervention plus the Fresh Start VR experience |
| Brief motivational interventionBrief motivational intervention is a standard, two-session brief motivational intervention that will involve personalized normative feedback, techniques intended to help explore and resolve ambivalence about drinking, and potential options for change. Each session will last approximately 60 minutes. | Behavioural | Brief motivational intervention, Brief motivational intervention plus the Fresh Start VR experience |
Primary outcome
Adoption: percentage of participants who agree to use VR when offered in counseling
Time frame: During the intervention session (at Baseline)
Adoption of VR will be assessed by calculating the percentage of participants assigned to the VR condition who agree to use VR when offered by a counselor during a counseling session.
Tolerability: percentage of participants who discontinue VR after starting
Time frame: During the intervention session (at Baseline)
Tolerability will be assessed by calculating the percentage of participants assigned to the VR condition who discontinue using VR after starting to use it.
Feasibility: total score on the Feasibility of Intervention Measure
Time frame: Immediately following the intervention session (at Baseline)
Feasibility of using VR within brief alcohol counseling sessions will be assessed using the Feasibility of Intervention Measure, a 4-item measure that assesses items such as "Using VR in counseling sessions seems doable." Each item is assessed on a 5-point scale from 1 (completely disagree) to 5 (completely agree). Each participant's total score on the FIM will serve as the primary outcome and will be compared across groups.
Acceptability: total score on the Acceptability of Intervention Measure
Time frame: Immediately following the intervention session (at Baseline)
Acceptability of using VR within brief alcohol counseling sessions will be assessed using the Acceptability of Intervention Measure (AIM), a 4-item measure that assesses items such as "Using VR in counseling sessions is appealing to me." Each item is assessed on a 5-point scale from 1 (completely disagree) to 5 (completely agree). Each participant's total score on the AIM will serve as the primary outcome and will be compared across groups.
Satisfaction: total score on the Client Satisfaction Scale 8 (CSQ-8)
Time frame: Immediately following the intervention session (at Baseline)
Satisfaction with counseling will be assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item measure that assesses items such as "How would you rate the quality of service you have received?" Each item is rated on a 4-point scale, but the response options vary by item (e.g., item 1 ranges from 1 [poor] to 4 [excellent]). Each participant's total score on the CSQ-8 will serve as the primary outcome and will be compared across groups.
3 secondary outcomes
Average drinks per drinking day: The average number of drinks consumed per drinking day over the previous 28 days, as assessed by online Timeline Followback (TLFB) assessment
Time frame: Baseline, 1 month, 2 months, 3 months, and 6 months
Heavy episodic drinking days: Total number of days on which participants reported drinking 4+ drinks (for women) or 5+ drinks (for men) over the previous 28 days, as assessed by online Timeline Followback (TLFB) assessment
Time frame: Baseline, 1 month, 2 months, 3 months, and 6 months
Alcohol-related problems: Total number of alcohol-related problems in the past 28 days as assessed by the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
Time frame: Baseline, 1 month, 2 months, 3 months, and 6 months
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 28 Oct 2026.
- Individual participant dataSharing planned: Yes. Data on key outcomes, including both primary outcomes (adoption, tolerability, feasibility, acceptability) and secondary, preliminary efficacy outcomes (average drinks per drinking days, total count of heavy episodic days, and total count of alcohol-related problems) will be shared with the NIAAA Data Archive, in alignment with NIH and NIAAA policy. Only data from participants who specifically consent to having their data archived during the informed consent process will be shared.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality experience and Brief motivational intervention in people with Alcohol Misuse, run by Brown University.
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 4 inclusion and 7 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Kristina Project Manager (401-863-3610, kristina_morreale@brown.edu401-863-3610), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption: percentage of participants who agree to use VR when offered in counseling (time frame: During the intervention session (at Baseline)). The study lists 5 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 28 Oct 2026.