A Phase 1 interventional study of SOBER-VR in Alcohol-associated Liver Disease, sponsored by The Cleveland Clinic. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by The Cleveland Clinic · Phase 1, Interventional, and Device feasibility
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.
The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
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Exclusion Criteria:
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.
Device: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 8
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
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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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