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Behavioral Intervention

Digital CBT for Scoliosis Recovery (SurgeryPal Trial)

N/A

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery

Awards & highlights

SurgeryPal Trial 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.Check my eligibility

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.See study design

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.

SurgeryPal Trial 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.

SurgeryPal Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Chronic pain intensity and interference

Post-surgical pain intensity and interference

Secondary outcome measures

Change in health-related quality of life

Change in mental health

Change in opioid misuse

+5 more

SurgeryPal 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

~4770

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityOTHER

704 Previous Clinical Trials

6,142,863 Total Patients Enrolled

Seattle Children's HospitalLead Sponsor

302 Previous Clinical Trials

5,216,224 Total Patients Enrolled

Duke UniversityOTHER

2,363 Previous Clinical Trials

3,419,986 Total Patients Enrolled

Media Library

Education (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04637802 — N/A

Spondylolisthesis 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)

Spondylolisthesis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the qualifications to participate in this research?

"This medical research requires 500 young individuals aged 12 to 18 with kyphosis. To qualify, candidates must be a minor, scheduled for spinal fusion surgery (due to juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis), and have the consent of their parent or legal guardian."

Answered by AI

Is the age bracket for participants of this trial limited to adults over 35?

"According to the study's criteria, appropriate participants are within the adolescent range of 12-18. Specifically, we have 74 medical trials for those under 18 years old and 54 for people above 65."

Answered by AI

How many people are enrolled in this clinical experiment?

"Yes, according to clinicaltrials.gov, this medical trial is presently looking for participants and has been since December 29th 2020. The last edit was on August 9th 2022, with a need of 500 patients from one location."

Answered by AI

What are the desired outcomes of this research project?

"This medical trial will assess, over a three-week period following surgery, the chronic pain intensity and interference experienced by participants. Secondary objectives include evaluating changes in mental health (through Parents' and Teen's self-reports on Patient Health Questionnaire-4), sleep quality (using the Adolescent Sleep Wake Scale 10-item version) as well as levels of catastrophizing about pain felt by both child patients and their parents (utilising Pain Catastrophizing Scale)."

Answered by AI

Is it still possible to enroll in this clinical trial?

"The clinicaltrials.gov website confirms that this investigation is currently recruiting participants for the trial, which was initially advertised on December 29th 2020 and most recently updated on August 9th 2022."

Answered by AI

Recent research and studies

TrialsJournal

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 a Multisite Randomized Controlled Trial

Rabbitts, Jennifer A., Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray, and Tonya M. Palermo. 2021. “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 a Multisite Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05421-3.

TrialsJournal

clinicaltrials.govStudy

Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

Jennifer Rabbitts, MBChB 2020. "Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04637802.

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