Alcohol-associated Liver DiseasePhase 1SOBER-VRNCT07874802
An AI-powered Virtual Reality Brief Intervention for Hospitalized Patients With Alcohol-Associated Liver Disease (SOBER-VR)
A Phase 1 study testing SOBER-VR in people with Alcohol-associated Liver Disease, run by The Cleveland Clinic.
Trial summary
Alcohol-associated liver disease (ALD) is a leading cause of preventable liver-related morbidity and mortality, with hospitalizations for ALD increasing significantly in recent years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-associated Liver Disease
- What is being tested?
- SOBER-VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2027
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- Patients with lived experience of inpatient admissions due to ALD OR a Cleveland Clinic nurse (with experience in healthcare quality)
- English-speaking
Who cannot join
- Unwilling and/or unable to participate
- Non-English speakers
- Delirium/acute encephalopathy prevents safe participation
- Self-reported history of acute and/or severe motion sickness
- The presence of a facial/head deformity that will prohibit the wearing of a VR HMD
- Legally blind or deaf
- Having had a seizure in the past year
- Those who are pregnant
About this study
Official title: SOBER-VR: An AI-powered Virtual Reality Brief Intervention for Hospitalized Patients With Alcohol-Associated Liver Disease
Alcohol-associated liver disease (ALD) is a leading cause of preventable liver-related morbidity and mortality, with hospitalizations for ALD increasing significantly in recent years. Many patients with ALD and active alcohol use disorder (AUD) are discharged from the hospital without receiving evidence-based behavioral interventions, despite hospitalization representing a teachable moment when patients may be more motivated to change. Psychosocial support in this setting is often limited by short inpatient stays, provider shortages, and workflow barriers. Novel digital health approaches are needed to increase access to structured, personalized behavioral support during hospitalization.
This project aims to assess the feasibility, usability, and clinical relevance of SOBER-VR, a virtual reality (VR) and artificial intelligence (AI)-powered digital therapeutic that delivers motivational interviewing (MI) to hospitalized patients with ALD and active alcohol use. SOBER-VR uses immersive VR to enhance emotional salience and a large language model (LLM)-driven conversational agent to simulate reflective, MI-consistent interactions. The intervention is brief (10-15 minutes), self-guided, and delivered using sanitized, standalone VR headsets with real-time support from trained staff.
Using the NIH ORBIT Model for behavioral intervention development, this Phase Ib single-arm feasibility study will recruit 30 hospitalized patients with ALD and active alcohol use. Participants will use SOBER-VR during their inpatient stay and complete structured assessments post-discharge. The study will evaluate feasibility (recruitment, engagement, and retention), acceptability, usability, and safety of SOBER-VR. Preliminary signals of clinical impact, such as readiness to change, attitude to AUD treatment, among others, will also be explored.
- Conditions
- Alcohol-associated Liver Disease
- Being tested
- SOBER-VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOBER-VRDevice
A virtual reality (VR) and artificial intelligence (AI)-powered digital therapeutic that delivers motivational interviewing (MI) to hospitalized patients with ALD and active alcohol use. SOBER-VR uses immersive VR to enhance emotional salience and a large language model (LLM)-driven conversational agent to simulate reflective, MI-consistent interactions.
| Study group | Role | What they receive |
|---|---|---|
| SOBER-VR cue exposure therapy feasibility | Experimental | Patient and nurse participants will complete four bi-weekly (twice a month) co-design sessions over two months. Sessions will involve hands-on testing with SOBER-VR to gather feedback on user interface, hardware ergonomics, and comfort. Receives: Device: SOBER-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOBER-VR Intervention Feasibility, calculated by eligibility yield, consent rate, intervention uptake, and follow-up completion percentages
We will consider the study feasible if: >60% of eligible patients consent, >80% of randomized participants complete ≥1 session, and >70% complete follow-up interviews before discharge.
Measured: Week 8
System Usability Scale (SUS) of SOBER-VR
Usability. SUS (score ≥70will indicate acceptable usability) and a structured interview, which explores overall satisfaction, comfort with the VR experience, and perceived relevance of the content.
Measured: Week 8
SOBER-VR Acceptability through qualitative satisfaction ratings
Measured via structured discharge interviews and satisfaction ratings, focusing on perceptions of SOBER-VR's clarity and overall experience.
Measured: Week 8
Incidence of Adverse Events
Safety of the SOBER-VR intervention will be assessed by incidence of adverse events, including cybersickness, emotional distress, etc.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-associated Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Yee Hui Yeo, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874802
- Sponsor's protocol ID
- 26-503
- Other IDs
- K23AA033142-01
- Acronym
- SOBER-VR
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOBER-VR: An AI-powered Virtual Reality Brief Intervention for Hospitalized Patients With Alcohol-Associated Liver Disease
- ClinicalTrials.gov ID
- NCT07874802
- Acronym / sponsor ID
- SOBER-VR / 26-503
- Conditions
- Alcohol-associated Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 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.
Alcohol-associated liver disease (ALD) is a leading cause of preventable liver-related morbidity and mortality, with hospitalizations for ALD increasing significantly in recent years. Many patients with ALD and active alcohol use disorder (AUD) are discharged from the hospital without receiving evidence-based behavioral interventions, despite hospitalization representing a teachable moment when patients may be more motivated to change. Psychosocial support in this setting is often limited by short inpatient stays, provider shortages, and workflow barriers. Novel digital health approaches are needed to increase access to structured, personalized behavioral support during hospitalization.
This project aims to assess the feasibility, usability, and clinical relevance of SOBER-VR, a virtual reality (VR) and artificial intelligence (AI)-powered digital therapeutic that delivers motivational interviewing (MI) to hospitalized patients with ALD and active alcohol use. SOBER-VR uses immersive VR to enhance emotional salience and a large language model (LLM)-driven conversational agent to simulate reflective, MI-consistent interactions. The intervention is brief (10-15 minutes), self-guided, and delivered using sanitized, standalone VR headsets with real-time support from trained staff.
Using the NIH ORBIT Model for behavioral intervention development, this Phase Ib single-arm feasibility study will recruit 30 hospitalized patients with ALD and active alcohol use. Participants will use SOBER-VR during their inpatient stay and complete structured assessments post-discharge. The study will evaluate feasibility (recruitment, engagement, and retention), acceptability, usability, and safety of SOBER-VR. Preliminary signals of clinical impact, such as readiness to change, attitude to AUD treatment, among others, will also be explored.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOBER-VR cue exposure therapy feasibility | Experimental | Device: SOBER-VRPatient and nurse participants will complete four bi-weekly (twice a month) co-design sessions over two months. Sessions will involve hands-on testing with SOBER-VR to gather feedback on user interface, hardware ergonomics, and comfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years of age
- Patients with lived experience of inpatient admissions due to ALD OR a Cleveland Clinic nurse (with experience in healthcare quality)
- English-speaking
Key exclusion criteria (8 listed)
- Unwilling and/or unable to participate
- Non-English speakers
- Delirium/acute encephalopathy prevents safe participation
- Self-reported history of acute and/or severe motion sickness
- The presence of a facial/head deformity that will prohibit the wearing of a VR HMD
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 |
|---|---|---|
| SOBER-VRA virtual reality (VR) and artificial intelligence (AI)-powered digital therapeutic that delivers motivational interviewing (MI) to hospitalized patients with ALD and active alcohol use. SOBER-VR uses immersive VR to enhance emotional salience and a large language model (LLM)-driven conversational agent to simulate reflective, MI-consistent interactions. | Device | SOBER-VR cue exposure therapy feasibility |
Primary outcome
SOBER-VR Intervention Feasibility, calculated by eligibility yield, consent rate, intervention uptake, and follow-up completion percentages
Time frame: Week 8
We will consider the study feasible if: >60% of eligible patients consent, >80% of randomized participants complete ≥1 session, and >70% complete follow-up interviews before discharge.
System Usability Scale (SUS) of SOBER-VR
Time frame: Week 8
Usability. SUS (score ≥70will indicate acceptable usability) and a structured interview, which explores overall satisfaction, comfort with the VR experience, and perceived relevance of the content.
SOBER-VR Acceptability through qualitative satisfaction ratings
Time frame: Week 8
Measured via structured discharge interviews and satisfaction ratings, focusing on perceptions of SOBER-VR's clarity and overall experience.
Incidence of Adverse Events
Time frame: Week 8
Safety of the SOBER-VR intervention will be assessed by incidence of adverse events, including cybersickness, emotional distress, etc.
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 15 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOBER-VR in people with Alcohol-associated Liver Disease, run by The Cleveland Clinic.
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 3 inclusion and 8 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 15 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOBER-VR Intervention Feasibility, calculated by eligibility yield, consent rate, intervention uptake, and follow-up completion percentages (time frame: Week 8). The study lists 4 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 15 Oct 2026.