Degenerative Spine DiseaseVR-CBTNCT07777679
VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery
A study testing Virtual Reality-Based CBT Prehabilitation (VR-CBT) and CBT Prehabilitation without Virtual Reality in people with Degenerative Spine Disease and Spinal Stenosis Lumbar, run by University of California, Irvine at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Spine Disease, Spinal Stenosis Lumbar
- What is being tested?
- Virtual Reality-Based CBT Prehabilitation (VR-CBT) and CBT Prehabilitation without Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2026to 28 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 75 years old.
- Diagnosis of thoracolumbar adult spinal deformity (ASD), including but not limited to adult scoliosis, kyphosis, or spondylolisthesis, confirmed radiographically using SRS-Schwab classification criteria.
- Scheduled for elective spinal surgery involving fusion of more than four spinal levels.
- Moderate to severe chronic pain, assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).
- Ability to participate in an 8-week preoperative prehabilitation program.
- Adequate cognitive functioning and English language skills to engage in CBT or VR-CBT treatments.
- Ability to provide written informed consent and adhere to study procedures and follow-up visits.
Who cannot join
- Neurological conditions that significantly impact cognition or mobility.
- Active spinal infection, malignancy, or significant spinal trauma.
- Unmanaged medical conditions that could affect participation in the study.
- Pregnancy or plans to become pregnant during the study period.
- Severe visual impairment, claustrophobia, or other conditions that prevent safe use of VR technology.
- Cognitive impairment preventing adherence to study procedures.
- History of non-compliance with medical treatment or failure to adhere to study visits and follow-up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
UCI Health - Orthopaedic Spine Center (Wen Center for Advanced Care)
Irvine, California, 92617
George Habib, BS, 9096965362, habibg@hs.uci.edu
Paritash Tahmasebpour, MD, MBA, 6262166014, paritash.tah@gmail.com
Hoag Memorial Hospital Presbyterian (Hoag Hospital Newport Beach)
Newport Beach, California, 92663
Paritash Tahmasebpour, MD, MBA, 6262166014, paritash.tah@gmail.com
George H Habib, BS, 9096965362, habibg@hs.uci.edu
About this study
Official title: A Randomized Controlled Pilot Trial Evaluating Virtual Reality-Based Cognitive Behavioral Therapy (VR-CBT) as a Prehabilitation Intervention for Adult Spinal Deformity Surgery
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Degenerative Spine Disease, Spinal Stenosis Lumbar
- Being tested
- Virtual Reality-Based CBT Prehabilitation (VR-CBT), CBT Prehabilitation without Virtual Reality
- Keywords
- Virtual reality-based cognitive behavioral therapy, Patient-reported outcomes, Spine surgery prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based CBT Prehabilitation (VR-CBT)Behavioural
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.
CBT Prehabilitation without Virtual RealityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT Prehabilitation with Virtual Reality Exposure | Experimental | 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 Receives: Behavioral: Virtual Reality-Based CBT Prehabilitation (VR-CBT) |
| CBT Prehabilitation without Virtual Reality | Active comparator | 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. Receives: Behavioral: CBT Prehabilitation without Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Baseline (preoperative) and 12 months after surgery.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (preoperative) and repeated postoperative assessments through 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Nov 2028 (estimated)
- Study completion28 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Degenerative Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Oh, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777679
- Sponsor's protocol ID
- STUDY00001948
- Acronym
- VR-CBT
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng H, Li C, Liu J, Wang L, Ma J, Li G, Gan L, Shang X, Wu Z. Virtual Reality Rehabilitation Versus Conventional Physical Therapy for Improving Balance and Gait in Parkinson's Disease Patients: A Randomized Controlled Trial. Med Sci Monit. 2019 Jun 5;25:4186-4192. doi: 10.12659/MSM.916455.
PubMed 31165721Montgomery EY, Pernik MN, Johnson ZD, Dosselman LJ, Christian ZK, Deme PR, Adeyemo EA, Barrie U, Badejo O, Stewart NA, Uttarkar R, Adogwa O, Tecle NE, Aoun SG, Bagley CA. Perioperative Factors Associated With Chronic Opioid Use After Spine Surgery. Global Spine J. 2023 Jul;13(6):1450-1456. doi: 10.1177/21925682211035723. Epub 2021 Aug 20.
PubMed 34414800Li R, Li Y, Kong Y, Li H, Hu D, Fu C, Wei Q. Virtual Reality-Based Training in Chronic Low Back Pain: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2024 Feb 26;26:e45406. doi: 10.2196/45406.
PubMed 38407948Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033.
PubMed 26903081Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
PubMed 17180640Misterska E, Tomaszewski M, Gorski F, Gapsa J, Slysz A, Glowacki M. Assessing the Efficacy of Cognitive-Behavioral Therapy on Body Image in Adolescent Scoliosis Patients Using Virtual Reality. J Clin Med. 2024 Oct 26;13(21):6422. doi: 10.3390/jcm13216422.
PubMed 39518561Lee M, Jang S, Shin HK, Choi SW, Kim HT, Oh J, Kwon JH, Choi Y, Kang S, Back IS, Kim JK, Lee S, Seok JH. Virtual Reality-Based Cognitive Behavior Therapy for Major Depressive Disorder: An Alternative to Pharmacotherapy for Reducing Suicidality. Yonsei Med J. 2025 Jan;66(1):25-36. doi: 10.3349/ymj.2024.0002.
PubMed 39742882Dellazizzo L, Potvin S, Phraxayavong K, Dumais A. One-year randomized trial comparing virtual reality-assisted therapy to cognitive-behavioral therapy for patients with treatment-resistant schizophrenia. NPJ Schizophr. 2021 Feb 12;7(1):9. doi: 10.1038/s41537-021-00139-2.
PubMed 33580033Brea-Gomez B, Torres-Sanchez I, Ortiz-Rubio A, Calvache-Mateo A, Cabrera-Martos I, Lopez-Lopez L, Valenza MC. Virtual Reality in the Treatment of Adults with Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Int J Environ Res Public Health. 2021 Nov 11;18(22):11806. doi: 10.3390/ijerph182211806.
PubMed 34831562Goudman L, Jansen J, Billot M, Vets N, De Smedt A, Roulaud M, Rigoard P, Moens M. Virtual Reality Applications in Chronic Pain Management: Systematic Review and Meta-analysis. JMIR Serious Games. 2022 May 10;10(2):e34402. doi: 10.2196/34402.
PubMed 35536641Eubanks JE, Carlesso C, Sundaram M, Bejarano G, Smeets RJEM, Skolasky R, Vanushkina M, Turner R, Schneider MJ. Prehabilitation for spine surgery: A scoping review. PM R. 2023 Oct;15(10):1335-1350. doi: 10.1002/pmrj.12956. Epub 2023 Apr 3.
PubMed 36730164Strom J, Bjerrum MB, Nielsen CV, Thisted CN, Nielsen TL, Laursen M, Jorgensen LB. Anxiety and depression in spine surgery-a systematic integrative review. Spine J. 2018 Jul;18(7):1272-1285. doi: 10.1016/j.spinee.2018.03.017. Epub 2018 Apr 9.
PubMed 29649613Safaee MM, Ames CP, Smith JS. Epidemiology and Socioeconomic Trends in Adult Spinal Deformity Care. Neurosurgery. 2020 Jul 1;87(1):25-32. doi: 10.1093/neuros/nyz454.
PubMed 31620794Diebo BG, Shah NV, Boachie-Adjei O, Zhu F, Rothenfluh DA, Paulino CB, Schwab FJ, Lafage V. Adult spinal deformity. Lancet. 2019 Jul 13;394(10193):160-172. doi: 10.1016/S0140-6736(19)31125-0. Epub 2019 Jul 11.
PubMed 31305254
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Trial Evaluating Virtual Reality-Based Cognitive Behavioral Therapy (VR-CBT) as a Prehabilitation Intervention for Adult Spinal Deformity Surgery
- ClinicalTrials.gov ID
- NCT07777679
- Acronym / sponsor ID
- VR-CBT / STUDY00001948
- Conditions
- Degenerative Spine Disease, Spinal Stenosis Lumbar
- Keywords
- Virtual reality-based cognitive behavioral therapy, Patient-reported outcomes, Spine surgery prehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Nov 2028 (estimated)
- Study completion
- 28 Nov 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT Prehabilitation with Virtual Reality Exposure | Experimental | Behavioral: Virtual Reality-Based CBT Prehabilitation (VR-CBT)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 |
| CBT Prehabilitation without Virtual Reality | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults between 18 and 75 years old.
- Diagnosis of thoracolumbar adult spinal deformity (ASD), including but not limited to adult scoliosis, kyphosis, or spondylolisthesis, confirmed radiographically using SRS-Schwab classification criteria.
- Scheduled for elective spinal surgery involving fusion of more than four spinal levels.
- Moderate to severe chronic pain, assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).
- Ability to participate in an 8-week preoperative prehabilitation program.
Key exclusion criteria (7 listed)
- Neurological conditions that significantly impact cognition or mobility.
- Active spinal infection, malignancy, or significant spinal trauma.
- Unmanaged medical conditions that could affect participation in the study.
- Pregnancy or plans to become pregnant during the study period.
- Severe visual impairment, claustrophobia, or other conditions that prevent safe use of VR technology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Based CBT Prehabilitation (VR-CBT)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. | Behavioural | CBT Prehabilitation with Virtual Reality Exposure |
| CBT Prehabilitation without Virtual RealityA 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. | Behavioural | CBT Prehabilitation without Virtual Reality |
Primary outcome
Change in Oswestry Disability Index (ODI) Score from Baseline to 12 Months After Surgery
Time frame: Baseline (preoperative) and 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.
Change in pain intensity (VAS/NRS) from baseline to 12 months after surgery
Time frame: Baseline (preoperative) and 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
Change in functional mobility (Timed Up and Go and Functional Gait Assessment) from baseline to 12 months after surgery
Time frame: Baseline (preoperative) and 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.
5 secondary outcomes
Change in psychological distress (Pain Catastrophizing Scale) from baseline to 12 months after surgery
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
Time frame: Baseline (preoperative) and 12 months after surgery
Change in postural awareness score from baseline to 12 months after surgery
Time frame: Baseline (preoperative) and 12 months after surgery.
Postoperative opioid use through 12 months after surgery
Time frame: From hospital discharge through 12 months after surgery.
Postoperative functional recovery through 12 months after surgery
Time frame: Baseline (preoperative) and repeated postoperative assessments through 12 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 31165721Feng H, Li C, Liu J, Wang L, Ma J, Li G, Gan L, Shang X, Wu Z. Virtual Reality Rehabilitation Versus Conventional Physical Therapy for Improving Balance and Gait in Parkinson's Disease Patients: A Randomized Controlled Trial. Med Sci Monit. 2019 Jun 5;25:4186-4192. doi: 10.12659/MSM.916455.
- Background: PubMed 34414800Montgomery EY, Pernik MN, Johnson ZD, Dosselman LJ, Christian ZK, Deme PR, Adeyemo EA, Barrie U, Badejo O, Stewart NA, Uttarkar R, Adogwa O, Tecle NE, Aoun SG, Bagley CA. Perioperative Factors Associated With Chronic Opioid Use After Spine Surgery. Global Spine J. 2023 Jul;13(6):1450-1456. doi: 10.1177/21925682211035723. Epub 2021 Aug 20.
- Background: PubMed 38407948Li R, Li Y, Kong Y, Li H, Hu D, Fu C, Wei Q. Virtual Reality-Based Training in Chronic Low Back Pain: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2024 Feb 26;26:e45406. doi: 10.2196/45406.
- Background: PubMed 26903081Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033.
- Background: PubMed 17180640Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
- Background: PubMed 39518561Misterska E, Tomaszewski M, Gorski F, Gapsa J, Slysz A, Glowacki M. Assessing the Efficacy of Cognitive-Behavioral Therapy on Body Image in Adolescent Scoliosis Patients Using Virtual Reality. J Clin Med. 2024 Oct 26;13(21):6422. doi: 10.3390/jcm13216422.
- Background: PubMed 39742882Lee M, Jang S, Shin HK, Choi SW, Kim HT, Oh J, Kwon JH, Choi Y, Kang S, Back IS, Kim JK, Lee S, Seok JH. Virtual Reality-Based Cognitive Behavior Therapy for Major Depressive Disorder: An Alternative to Pharmacotherapy for Reducing Suicidality. Yonsei Med J. 2025 Jan;66(1):25-36. doi: 10.3349/ymj.2024.0002.
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- Provides plain-language information from the U.S. National Library of Medicine about how cognitive behavioral therapy helps people manage chronic back pain, including core CBT techniques and their role in spine care.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based CBT Prehabilitation (VR-CBT) and CBT Prehabilitation without Virtual Reality in people with Degenerative Spine Disease and Spinal Stenosis Lumbar, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Micheal Y Oh, MD (714-456-7012, ohm2@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777679, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.