VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality-Based CBT Prehabilitation (VR-CBT)
BehavioralA 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 Reality
BehavioralA 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: CBT Prehabilitation with Virtual Reality ExposureExperimental treatment 1 intervention
Group B: CBT Prehabilitation without Virtual RealityActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgery2
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 surgery3
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.Secondary outcomes
1
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.2
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 surgery3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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