Digital CBT for Scoliosis Recovery

(SurgeryPal Trial)

Overseen By Tonya Palermo, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Severe learning disability, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

433 Participants Needed

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Phase

Participants receive the SurgeryPal or Education intervention over the 4 weeks leading up to surgery

4 weeks

Weekly virtual sessions

Post-operative Phase

Participants receive the SurgeryPal or Education intervention for 4 weeks following surgery

4 weeks

Daily virtual assessments for 14 days

Follow-up

Participants are monitored for safety and effectiveness at 3 and 6 months post-surgery

6 months

Assessments at 3 and 6 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Education
• SurgeryPal

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Connecticut Children's Medical Center

Collaborator

Trials

76

Recruited

30,000+