VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery

Overview

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.

Elective spine surgery is commonly performed to address pain, neurologic symptoms, and functional limitations, yet many patients experience persistent postoperative pain, anxiety, and impaired quality of life despite technically successful procedures. Psychological factors such as catastrophizing, fear of movement, and low self-efficacy are strongly associated with poorer recovery trajectories after spine surgery. Virtual reality-based cognitive behavioral therapy (VR-CBT) is an emerging, scalable approach that can deliver structured coping skills training and exposure-based exercises in an immersive environment, potentially enhancing preoperative preparedness and postoperative recovery. This multi-site, interventional clinical trial will evaluate two formats of a CBT-based prehabilitation program for adults undergoing elective spine surgery at UC Irvine and Hoag Memorial Hospital Presbyterian. Each participant's study involvement lasts approximately 12 months and includes an 8-week preoperative prehabilitation period followed by postoperative follow-up through 12 months after surgery. The primary objective is to determine whether delivering spine-focused CBT prehabilitation using a virtual reality platform (VR-CBT) leads to better patient-reported outcomes and functional recovery at 12 months after surgery compared with the same CBT prehabilitation delivered without virtual reality. Secondary objectives include examining the effects of VR-CBT versus non-VR CBT on pain intensity, pain interference, mood symptoms (e.g., anxiety and depression), health-related quality of life, and patient satisfaction with care. Eligible patients scheduled for qualifying spine procedures at participating sites will be approached in the clinic and, after providing informed consent, enrolled and assigned either to receive CBT prehabilitation delivered with VR-based exposure (VR-CBT) or to receive the same CBT prehabilitation without VR (standard CBT), in both cases alongside usual perioperative clinical care. The VR-CBT program consists of multiple home-based sessions delivered via a virtual reality headset and software platform over the 8-week preoperative window. Session content focuses on psychoeducation about surgery and recovery, cognitive restructuring, relaxation and mindfulness skills, graded exposure to movement and pain-related cues, and rehearsal of adaptive coping strategies in immersive VR environments. In the comparator arm, participants receive the same CBT content through non-VR delivery methods (e.g., in-person or video-based sessions and written/online materials) without access to VR technology. Research-specific assessment visits of approximately 45-60 minutes are aligned whenever possible with routine clinical visits at each site to minimize participant burden. Participants complete validated questionnaires assessing pain, function, and psychosocial factors at baseline (before starting CBT with or without VR), after the prehabilitation period, and at multiple postoperative time points through 12 months. Additional data are abstracted from the electronic medical record, including details of the surgical procedure, perioperative complications, healthcare utilization, and opioid prescriptions. These data will be used to explore whether VR-CBT prehabilitation influences not only patient-reported outcomes but also clinical recovery metrics and resource use across sites. Safety monitoring is conducted under the oversight of the Institutional Review Boards at each participating institution, including UC Irvine (ZotIRB). Adverse events, including unexpected psychological distress or intolerance of VR use, are recorded throughout study participation and managed according to institutional policies. Because this is a behavioral intervention study that does not involve an FDA-regulated drug or device, no Investigational New Drug (IND) application or Investigational Device Exemption (IDE) is required, and an independent data monitoring committee is not convened. Results from this trial are intended to inform whether VR-CBT prehabilitation is a feasible and potentially effective strategy to improve recovery and long-term outcomes for patients undergoing spine surgery, and to guide the design of future larger-scale studies.