VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery (VR-CBT)

August 20, 2026 updated by: Michael Oh, University of California, Irvine

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?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92617
        • UCI Health - Orthopaedic Spine Center (Wen Center for Advanced Care)
        • Contact:
        • Contact:
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian (Hoag Hospital Newport Beach)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBT Prehabilitation with Virtual Reality Exposure
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)
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.
Active Comparator: CBT Prehabilitation without Virtual Reality
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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (preoperative) and 12 months after surgery
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
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
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.
Baseline (preoperative) and 12 months after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in psychological distress (Pain Catastrophizing Scale) from baseline to 12 months after surgery
Time Frame: Baseline (preoperative) and 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.
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
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.
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.
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.
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.
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.
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.
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.
Baseline (preoperative) and repeated postoperative assessments through 12 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001948 (Tufts Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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