VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT07777679
Status
Not Yet Recruiting

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Conditions

  • Degenerative Spine Disease
  • Spinal Stenosis Lumbar

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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 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.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Nov 28, 2028
Completion
Nov 28, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCI Health - Orthopaedic Spine Center (Wen Center for Advanced Care)IrvineCalifornia92617
George Habib, BS
9096965362
Paritash Tahmasebpour, MD, MBA
6262166014
Hoag Memorial Hospital Presbyterian (Hoag Hospital Newport Beach)Newport BeachCalifornia92663
Paritash Tahmasebpour, MD, MBA
6262166014
George H Habib, BS
9096965362

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