An interventional study of Virtual Reality experience and Brief motivational intervention in Alcohol Misuse, sponsored by Brown University. Not yet recruiting. Open to participants aged 18 Years to 34 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Brown University · Not applicable, Interventional, and Treatment
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.
156 studies on the registry are indexed under Alcohol-Related Disorders; 23 are open to participants now.
This study's planned enrollment of 120 is above the median of 101 across 131 interventional studies indexed under Alcohol-Related Disorders.
Browse Alcohol-Related Disorders studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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.
Behavioral: Brief motivational intervention
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.
Device: Virtual Reality experience · Behavioral: Brief motivational intervention
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 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately following the intervention session (at Baseline)
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.
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
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.
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)
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.
Time frame: Baseline, 1 month, 2 months, 3 months, and 6 months
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be shared by December of 2030 and will be available in perpetuity.
Access criteria: Investigators providing an acceptable purpose for use to the NIAAA Data Archive will be able to access the data.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.
Of 49 non-industry interventional studies with no phase under Alcohol-Related Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 44. This study's planned 35 months is above that.
Counting every sponsor, half of 49 studies reached it within 30 months; a quarter within 17 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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