VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery

NCT07777679 | Not Yet Recruiting

• 1 other identifier: STUDY00001948
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Degenerative Spine Disease; Spinal Stenosis Lumbar

Keywords

Virtual reality-based cognitive behavioral therapy; Patient-reported outcomes; Spine surgery prehabilitation

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  Baseline (preoperative) and 12 months after surgery.

Secondary Outcomes (5)

• Change in psychological distress (Pain Catastrophizing Scale) from baseline to 12 months after surgery

  Baseline (preoperative) and 12 months after surgery.

• Change in fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) from baseline to 12 months after surgery

  Baseline (preoperative) and 12 months after surgery

• Change in postural awareness score from baseline to 12 months after surgery

  Baseline (preoperative) and 12 months after surgery.

• Postoperative opioid use through 12 months after surgery

  From hospital discharge through 12 months after surgery.

• Postoperative functional recovery through 12 months after surgery

  Baseline (preoperative) and repeated postoperative assessments through 12 months after surgery.

Study Arms (2)

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

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.

Behavioral: CBT Prehabilitation without Virtual Reality

Interventions

Virtual Reality-Based CBT Prehabilitation (VR-CBT) BEHAVIORAL

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 with Virtual Reality Exposure

CBT Prehabilitation without Virtual Reality BEHAVIORAL

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.

CBT Prehabilitation without Virtual Reality

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (2)

UCI Health - Orthopaedic Spine Center (Wen Center for Advanced Care)

Irvine, California, 92617, United States

Location

Hoag Memorial Hospital Presbyterian (Hoag Hospital Newport Beach)

Newport Beach, California, 92663, United States

Location

Related Publications (14)

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• Misterska 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.

  PMID: 39518561 BACKGROUND

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• Dellazizzo 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.

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• Eubanks 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.

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• Strom 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.

  PMID: 29649613 BACKGROUND

• Safaee 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.

  PMID: 31620794 BACKGROUND

• Diebo 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.

  PMID: 31305254 BACKGROUND

Related Links

• 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.

Central Study Contacts

Micheal Y Oh, MD

CONTACT

714-456-7012; ohm2@hs.uci.edu

George H Habib, BS

CONTACT

9096965362; ghabib0379@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Neurological Surgery

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 28, 2028
• Study Completion (Estimated): November 28, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)