VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery
Part of paid clinical trials in Irvine, California.
- Sponsor
- University of California, Irvine
- Study ID
- NCT07777679
- Status
- Not Yet Recruiting
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Conditions
- Degenerative Spine Disease
- Spinal Stenosis Lumbar
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Virtual Reality-Based CBT Prehabilitation (VR-CBT) — BEHAVIORALA spine-focused cognitive behavioral therapy (CBT) prehabilitation program delivered using a virtual reality platform. Over 8 weeks before surgery, participants complete home-based VR sessions via a headset and software that provide psychoeducation about surgery and recovery, cognitive restructuring exercises, relaxation and mindfulness training, and graded exposure to movement and pain-related cues in immersive virtual environments. This intervention is administered in addition to usual perioperative clinical care.
- CBT Prehabilitation without Virtual Reality — BEHAVIORALA spine-focused CBT prehabilitation program delivered without VR. Over 8 weeks before surgery, participants receive the same CBT content using non-VR methods covering psychoeducation about surgery and recovery, cognitive restructuring, relaxation and mindfulness, and graded exposure to movement and pain-related cues. This intervention is administered in addition to usual perioperative clinical care.
Study Details
The goal of this clinical trial is to learn whether a virtual reality-based cognitive behavioral therapy (VR-CBT) prehabilitation program can improve recovery and quality of life for adults undergoing elective spine surgery. The main questions it aims to answer are: Does participating in an 8-week VR-CBT prehabilitation program before surgery improve physical function and pain-related outcomes at 12 months after surgery? Does VR-CBT prehabilitation reduce postoperative anxiety, depression, and pain interference compared with usual preoperative care? Researchers will compare participants who receive the VR-CBT prehabilitation program plus usual care to participants who receive usual preoperative care alone to see if the VR-CBT program leads to better recovery and patient-reported outcomes. Participants will: Use a VR headset at home to complete structured CBT-based prehabilitation sessions over 8 weeks before surgery. Attend routine clinic visits and complete questionnaires about pain, function, mood, and quality of life before surgery and through 12 months after surgery. Allow the research team to review their medical records for information about surgery, complications, and postoperative recovery.
Key Dates
- First listed
- Aug 20, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Nov 28, 2028
- Completion
- Nov 28, 2028
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CBT Prehabilitation with Virtual Reality ExposureParticipants receive a spine-focused CBT prehabilitation program delivered using a virtual reality platform (VR-CBT) in addition to usual perioperative clinical care. The 8-week preoperative program includes home-based VR sessions targeting psychoeducation about surgery and recovery, cognitive restructuring, relaxation and mindfulness, and graded exposure to movement and pain-related cues in immersive VR environments
- Active Comparator: CBT Prehabilitation without Virtual RealityParticipants receive the same spine-focused CBT prehabilitation content delivered without VR (standard CBT sessions/materials) in addition to usual perioperative clinical care. The 8-week preoperative program uses non-VR delivery methods (e.g., in-person or video-based sessions and written/online materials) covering psychoeducation, cognitive restructuring, relaxation and mindfulness, and graded exposure to movement and pain-related cues without VR technology.
Primary Outcome Measure
Change in Oswestry Disability Index (ODI) Score from Baseline to 12 Months After Surgery [ Time Frame: Baseline (preoperative) and 12 months after surgery ]
Central Contacts
- Micheal Y Oh, MD714-456-7012
- George H Habib, BS9096965362
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCI Health - Orthopaedic Spine Center (Wen Center for Advanced Care) | Irvine | California | 92617 | |
| Hoag Memorial Hospital Presbyterian (Hoag Hospital Newport Beach) | Newport Beach | California | 92663 |
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