An interventional study of Virtual Reality-Based CBT Prehabilitation (VR-CBT) and CBT Prehabilitation without Virtual Reality in Degenerative Spine Disease and Spinal Stenosis Lumbar, sponsored by University of California, Irvine. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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
Behavioral: Virtual Reality-Based CBT Prehabilitation (VR-CBT)
Participants 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.
Behavioral: CBT Prehabilitation without Virtual Reality
A 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.
A 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.
Change in Oswestry Disability Index (ODI) Score from Baseline to 12 Months After Surgery
The Oswestry Disability Index (ODI) is a patient-reported measure of back pain-related disability with scores ranging from 0 to 100, where higher scores indicate greater disability. Change is calculated as ODI score at 12 months after surgery minus the baseline (preoperative) ODI score.
Time frame: Baseline (preoperative) and 12 months after surgery
Change in pain intensity (VAS/NRS) from baseline to 12 months after surgery
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS) or Numeric Rating Scale (NRS), where higher scores indicate greater pain. Change in pain intensity will be calculated as the score at 12 months after surgery minus the baseline (preoperative) score
Time frame: Baseline (preoperative) and 12 months after surgery
Change in functional mobility (Timed Up and Go and Functional Gait Assessment) from baseline to 12 months after surgery
Functional mobility will be measured using the Timed Up and Go (TUG) test and the Functional Gait Assessment (FGA). TUG records the time in seconds required for a patient to stand from a chair, walk 3 meters, turn, walk back, and sit; longer times indicate worse mobility. FGA is a multi-item clinician-rated scale of dynamic gait stability with scores typically ranging from 0 to 30, where higher scores indicate better gait function. Change in functional mobility will be calculated as TUG time and FGA score at 12 months after surgery compared with baseline (preoperative) values.
Time frame: Baseline (preoperative) and 12 months after surgery.
Change in psychological distress (Pain Catastrophizing Scale) from baseline to 12 months after surgery
Psychological distress related to pain will be measured using the Pain Catastrophizing Scale (PCS), which assesses rumination, magnification, and helplessness about pain. PCS total scores (higher scores indicating greater catastrophizing) at 12 months after surgery will be compared with baseline scores to quantify change.
Time frame: Baseline (preoperative) and 12 months after surgery.
Change in fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) from baseline to 12 months after surgery
Fear-avoidant behaviors will be assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ), which evaluates fear-based beliefs about physical activity and work in relation to pain. FABQ subscale and total scores (higher scores indicating greater fear-avoidance) at 12 months after surgery will be compared with baseline scores.
Time frame: Baseline (preoperative) and 12 months after surgery
Change in postural awareness score from baseline to 12 months after surgery
Postural awareness will be assessed using a study-specific postural awareness measure (e.g., questionnaire or rating scale) designed to capture patients' awareness of spinal alignment and posture during daily activities. Higher scores will reflect greater postural awareness. Change in postural awareness will be calculated as the score at 12 months after surgery compared with baseline.
Time frame: Baseline (preoperative) and 12 months after surgery.
Postoperative opioid use through 12 months after surgery
Opioid use will be quantified using prescription and medication-use data abstracted from the electronic medical record. Outcomes will include total opioid consumption expressed in morphine milligram equivalents (MME) and patterns of opioid prescribing over the postoperative period.
Time frame: From hospital discharge through 12 months after surgery.
Postoperative functional recovery through 12 months after surgery
Postoperative functional recovery will be evaluated using a composite of functional mobility assessments (Timed Up and Go, Functional Gait Assessment) and patient-reported functional measures specified in the full protocol. Recovery will be characterized by the magnitude and trajectory of improvement in these measures over the 12-month postoperative period.
Time frame: Baseline (preoperative) and repeated postoperative assessments through 12 months after surgery.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Nov 2028, 26 months later.
Of 105 non-industry interventional studies with no phase under Spinal Stenosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 26 months is below that.
Counting every sponsor, half of 123 studies reached it within 30 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of California, Irvine →