Digital CBT for Scoliosis Recovery

(SurgeryPal Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Tonya Palermo, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Seattle Children's Hospital

No Placebo Group

Trial Summary

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).

Research Team

Jennifer Rabbitts, MD

Principal Investigator

Seattle Children's Hospital

Tonya Palermo, PhD

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

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

I am between 12 and 18 years old.

Parent or legal guardian of child who meets study criteria

I am scheduled for spinal fusion surgery for scoliosis, spondylolisthesis, or kyphosis.

Exclusion Criteria

Does not have access to a smart device (smartphone, iPad or tablet)

I have had major surgery before.

I am a teenager.

Treatment Details

Interventions

• Education (Behavioral Intervention)
• SurgeryPal (Behavioral Intervention)

Trial Overview The trial tests SurgeryPal, a digital psychosocial intervention based on CBT (Cognitive Behavioral Therapy), against standard educational materials. The study has two phases: one before surgery and one after. Participants are randomly assigned into four groups and assessed at baseline, shortly after surgery, then at 3 and 6 months post-surgery.

Participant Groups

Group I: Pre-operative and Post-operative CBT intervention (SurgeryPal) Experimental Treatment 1 Intervention

This arm receives access to CBT intervention during the pre-operative and post-operative period.

Group II: Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal) Experimental Treatment 2 Interventions

This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period.

Group III: Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention Experimental Treatment 2 Interventions

This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase.

Group IV: Pre-operative and Post-operative Education intervention Active Control 1 Intervention

This arm receives access to Patient Education intervention in the pre- and post-operative phases.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Seattle Children's Hospital Seattle, WA

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Patients Recruited

5,232,000+

Vanderbilt University

Collaborator

Trials

714

Patients Recruited

6,143,000+

Duke University

Collaborator

Trials

2495

Patients Recruited

5,912,000+

Johns Hopkins University

Collaborator

Trials

2366

Patients Recruited

15,160,000+

University of Utah

Collaborator

Trials

1169

Patients Recruited

1,623,000+

Connecticut Children's Medical Center

Collaborator

Trials

76

Patients Recruited

30,000+