Digital CBT for Scoliosis Recovery
(SurgeryPal Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).
Who Is on the Research Team?
Jennifer Rabbitts, MD
Principal Investigator
Seattle Children's Hospital
Tonya Palermo, PhD
Principal Investigator
Seattle Children's Hospital
Are You a Good Fit for This Trial?
This trial is for adolescents aged 12-18 scheduled for spinal fusion surgery due to conditions like scoliosis or kyphosis. Participants must understand English and have access to a smart device, though the study can provide an iPad if needed. It's not open to those with recent psychiatric admissions, severe chronic medical conditions, prior major surgeries, or significant cognitive impairments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Phase
Participants receive the SurgeryPal or Education intervention over the 4 weeks leading up to surgery
Post-operative Phase
Participants receive the SurgeryPal or Education intervention for 4 weeks following surgery
Follow-up
Participants are monitored for safety and effectiveness at 3 and 6 months post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Education
- SurgeryPal
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor
Vanderbilt University
Collaborator
Duke University
Collaborator
Johns Hopkins University
Collaborator
University of Utah
Collaborator
Connecticut Children's Medical Center
Collaborator