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Behavioral Intervention

Digital CBT for Scoliosis Recovery (SurgeryPal Trial)

N/A
Waitlist Available
Led By Jennifer Rabbitts, MD
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
12 to 18 years old at the time of enrollment
Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis)
Must not have
Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery)
Does not speak or understand English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the SurgeryPal intervention can improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery, compared to an education control. Participants will be randomized to one of four treatment arms, and will be assessed four times over the course of the study.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical interventions focusing on psychological support through CBT and education rather than drugs or invasive procedures, traditional side effects are not expected. However, participants may experience varying levels of engagement or emotional responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 18 years old.
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I am scheduled for spinal fusion surgery for scoliosis, spondylolisthesis, or kyphosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had major surgery before.
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I do not speak or understand English.
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I have a severe condition like neuromuscular scoliosis or cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chronic pain intensity and interference
Post-surgical pain intensity and interference
Secondary study objectives
Change in health-related quality of life
Change in mental health
Change in opioid misuse
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Pre-operative and Post-operative CBT intervention (SurgeryPal)Experimental Treatment1 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 Treatment2 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 interventionExperimental Treatment2 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 interventionActive Control1 Intervention
This arm receives access to Patient Education intervention in the pre- and post-operative phases.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education
2017
N/A
~4790

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,142,947 Total Patients Enrolled
Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,147 Total Patients Enrolled
Duke UniversityOTHER
2,463 Previous Clinical Trials
2,981,427 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,240 Total Patients Enrolled
1 Trials studying Kyphosis
48 Patients Enrolled for Kyphosis
University of UtahOTHER
1,147 Previous Clinical Trials
1,699,188 Total Patients Enrolled
Connecticut Children's Medical CenterOTHER
73 Previous Clinical Trials
26,160 Total Patients Enrolled
Jennifer Rabbitts, MDPrincipal Investigator - Seattle Children's Hospital
Seattle Children's Hospital
Tonya Palermo, PhDPrincipal InvestigatorSeattle Children's Hospital
2 Previous Clinical Trials
233 Total Patients Enrolled

Media Library

Education (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04637802 — N/A
Kyphosis Research Study Groups: Pre-operative and Post-operative Education intervention, Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention, Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal), Pre-operative and Post-operative CBT intervention (SurgeryPal)
Kyphosis Clinical Trial 2023: Education Highlights & Side Effects. Trial Name: NCT04637802 — N/A
Education (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04637802 — N/A
~9 spots leftby Jan 2025
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