← Back to Search

Cognitive Behavioral Therapy for Scoliosis (PASS Trial)

N/A

Recruiting

Led By Eric D Fornari, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group

Awards & highlights

No Placebo-Only Group

Summary

This trial will study AIS patients to understand how to reduce anxiety and pain with evidence-based cognitive behavioral therapy protocols.

Who is the study for?

This trial is for healthy, non-obese young people aged 12-19 with a diagnosis of idiopathic scoliosis who are about to have elective posterior spinal fusion surgery. They should be diagnosed before age 20 and will undergo mental health, pain, and function assessments.

What is being tested?

The study tests the ADAPT program—a psychological intervention based on cognitive behavioral therapy—to see if it can reduce anxiety and pain in patients undergoing scoliosis surgery. Participants are randomly assigned to receive this intervention or not.

What are the potential side effects?

Since ADAPT is a psychological intervention based on cognitive behavioral therapy, there may not be direct physical side effects like those seen with medications; however, participants might experience emotional discomfort during therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of changes in Mental health preoperatively and post postoperatively using the Patient Health Questionnaire (PHQ)-9.

Assessment of changes in Mental health preoperatively and postoperatively using Generalized Anxiety Disorder (GAD-7)

Assessment of changes in Mental health preoperatively and postoperatively using PROMIS- (Patient-Reported Outcomes Measurement Information System) short form for Depression

+2 more

Secondary study objectives

Assessment of changes in Function score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis

Assessment of changes in Satisfaction with management score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis

Assessment of changes in mental health preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis

+3 more