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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a digital program called SurgeryPal, which incorporates cognitive behavioral therapy (CBT), might aid young people in recovering from major spine surgeries, such as those for scoliosis. The study compares SurgeryPal to standard educational support, both before and after surgery, to determine which approach best reduces pain and improves overall health. Participants will be divided into four groups to test different combinations of CBT and educational support. Teens aged 12 to 18, scheduled for spinal fusion surgery for conditions like scoliosis and without major language or cognitive barriers, are suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on a regular treatment regimen for a severe chronic medical condition, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that digital health tools like SurgeryPal are usually easy for people to use. Studies have found that these tools help patients manage pain and improve their health. Most people find the digital therapy approach comfortable, with few reports of negative effects.

While specific data on SurgeryPal's safety is not available, digital health treatments are generally safe and effective. They are designed to help patients without causing harm. As a digital tool, not a medication or surgery, SurgeryPal is expected to have a low risk of side effects. Participants in the trial can expect SurgeryPal to assist with recovery and pain management safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for scoliosis recovery because they integrate digital cognitive behavioral therapy (CBT), offering a fresh approach to surgical preparation and recovery. Unlike traditional methods that primarily focus on physical rehabilitation and pain management, SurgeryPal uses digital CBT to address both mental and emotional aspects of recovery. This approach can help patients manage anxiety and pain perception, potentially leading to improved surgical outcomes. By incorporating CBT in different phases of treatment—pre-operative, post-operative, or both—these methods aim to enhance patient education and mental readiness, potentially reducing recovery time and improving overall patient experience.

What evidence suggests that this trial's treatments could be effective for scoliosis recovery?

Research shows that SurgeryPal, a digital program based on cognitive-behavioral therapy (CBT), may reduce both short-term and long-term pain after major surgeries like spinal fusion. In this trial, some participants will receive the SurgeryPal intervention either before or after surgery, or both. Studies have found that similar CBT programs can help teenagers manage pain and recover better after surgery. SurgeryPal helps patients change their thoughts and feelings about recovery, leading to better pain control and health outcomes. Early results suggest that using SurgeryPal before and after surgery could improve recovery and lessen long-term pain. ^{1 6 7 8 9}

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34330321/

A digital health peri-operative cognitive-behavioral ... - PubMed This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8325315/

A digital health peri-operative cognitive-behavioral ... Abstract. Background. Spinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents.

3. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/d/NCT04637802.html

Digital Health Psychosocial Intervention for Adolescent Spine ... This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and ...

4. researchgate.net researchgate.net/publication/353599976_A_digital_health_peri-operative_cognitive-behavioral_intervention_to_prevent_transition_from_acute_to_chronic_postsurgical_pain_in_adolescents_undergoing_spinal_fusion_SurgeryPalTM_study_protocol_for_

(PDF) A digital health peri-operative cognitive-behavioral ... This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs. education-control ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0897189704000539

Adolescent scoliosis: Effects of corrective surgery, cognitive ... The effects of spinal fusion surgery and cognitive-behavioral interventions on 88 adolescents' (11–18 years) activity outcomes were examined

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11546488/

Assessing the Efficacy of Cognitive-Behavioral Therapy on ... We revealed that irrespective of received therapeutic support, scoliosis patients accurately estimate their body shape pre- and postoperatively.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04637802?tab=table

Digital Health Psychosocial Intervention for Adolescent ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

8. stanfordhealthcare.org stanfordhealthcare.org/trials/d/NCT04637802.html

Digital Health Psychosocial Intervention for Adolescent ... This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health ...

9. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/20552076251328549

Digital health interventions for spinal surgery patients The potential of digital health interventions to optimize healthcare is promising also in the context of spinal surgery.