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NOT YET RECRUITING
NCT07874802
PHASE1

An AI-powered Virtual Reality Brief Intervention for Hospitalized Patients With Alcohol-Associated Liver Disease (SOBER-VR)

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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. 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.

Official title: SOBER-VR: An AI-powered Virtual Reality Brief Intervention for Hospitalized Patients With Alcohol-Associated Liver Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-11

Completion Date

2027-07

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

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.