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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

PASS Trial 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.Check my eligibility
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.See study design
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.

PASS Trial 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
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

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

PASS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: psychological intervention ADAPTExperimental Treatment1 Intervention
The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model.
Group II: standard of care control groups no psychological interventionActive Control1 Intervention
standard of care control groups no psychological intervention

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineOTHER
287 Previous Clinical Trials
11,856,988 Total Patients Enrolled
Montefiore Medical CenterLead Sponsor
444 Previous Clinical Trials
582,440 Total Patients Enrolled
Eric D Fornari, MDPrincipal InvestigatorMontefiore Medical Center

Frequently Asked Questions

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

Are there any current openings for participation in this scientific experiment?

"Yes, the details hosted on clinicaltrials.gov verify that this research study is actively recruiting participants. This trial was first posted on October 6th 2023 and has been revised most recently on November 27th 2023; it aims to enroll 100 patients at 1 medical centre."

Answered by AI

Is it possible to enlist in this experiment?

"This clinical study is seeking 100 participants between the age of 12 and 19 who were diagnosed with adolescent idiopathic scoliosis. To qualify, patients must be within a healthy BMI range, have been given their diagnosis before reaching 20 years old, and are scheduled for elective posterior spinal fusion surgery."

Answered by AI

How many individuals are participating in this research project?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical experiment, initially posted on October 6th 2023 is actively recruiting patients. The study requires 100 volunteers to be recruited from 1 location."

Answered by AI

Does this research endeavor accept participants who are over two decades old?

"The requirements for enrolment in this trial stipulate that prospective patients are between 12 and 19 years old. Currently, there exists 104 trials catering to minors, as well as 56 clinical studies targeting seniors above the age of 65."

Answered by AI

What are the primary aims of this clinical investigation?

"The overall aim of this study is to compare preoperative and postoperative mental health scores according to the Patient-Reported Outcomes Measurement Information System (PROMIS) short form for depression, as well as to evaluate sociodemographic factors using Child Opportunity Index (COI). Additionally, changes in satisfaction with management will be assessed through Scoliosis Research Society questionnaire-22 revised (SRS-22r), which also evaluates mental health by means of five questions. Assessments are planned at baseline and after 6 weeks, 6 months, and 1 year from surgery for both standard of care control group and psychological intervention group."

Answered by AI
~80 spots leftby Oct 2026