Clinical Trial

Virtual Intelligence for Transformative Lifestyle Solutions in Pain

Study acronym: VITALS-Pain
Completed
View on ClinicalTrials.gov →
Summary
This pilot study aims to evaluate the feasibility and acceptability of a VR-based chronic pain management intervention with a virtual AI coach for patients with Opioid misuse and opioid use disorder (OM/OUD). The intervention is a single-day 45-minute VR intervention which is subdivided into three smaller sessions: Session 1: A 15-minute AI check-in to ask questions about biopsychosocial health, Session 2: A 20-minute Pain Coping Skills Training (PCST) session offering psychoeducation on managing chronic pain Session 3: A 10-minute stress reduction exercise. The VR sessions will be conducted using hardware (VR Headset Device - Meta Quest 3) and software developed by AugMend Health Company. The study will be conducted in a clinical setting at the Montefiore Multidisciplinary Pain Medicine Program (MMPP), a Pain Medicine outpatient specialty practice within a major urban medical center. MMPP providers see thousands of patients every month, some of which have concurrent opioid misuse or OM/OUD.
Protocol Amendment History 6 changes
critical Trial completed 2026-08-12
notable Primary completion moved earlier: 2026-12 -> 2026-08-05 2026-08-12
minor Completion moved earlier: 2026-12 -> 2026-08-05 2026-08-12
critical Recruitment opened 2026-06-11
notable Primary completion pushed: 2026-07 -> 2026-12 2026-06-11
minor Completion pushed: 2026-07 -> 2026-12 2026-06-11
Trial Details
NCT Number NCT07124598
Lead Sponsor Montefiore Medical Center
Collaborators: National Institute on Drug Abuse (NIDA), AugMend Health
Conditions Chronic Pain
Enrollment 15 participants
Start Date 2026-07-10
Primary Completion 2026-08-05 (estimated)
Study Completion 2026-08-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-11