Actively Recruiting

Phase Not Applicable
Age: 10Years - 19Years
All Genders
ID05774002

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)

Led by Montefiore Medical Center · Updated on 2026-03-02

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

A

Albert Einstein College of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating mental health, pain, and function in adolescents aged 10 to 19 with Adolescent Idiopathic Scoliosis (AIS) undergoing spinal fusion surgery. The study aims to test a structured psychological intervention program called Aim to Decrease Anxiety and Pain Treatment (ADAPT), based on cognitive behavioral therapy (CBT) protocols, to manage pediatric pain and anxiety around surgery. The research focuses on improving both short-term and long-term physical and mental health outcomes after surgery while addressing risks like anxiety, depression, and opioid use. Participants are randomly assigned in a 2:1 ratio to either receive the ADAPT psychological intervention or standard care without psychological support. The ADAPT program involves one pre-operative and three post-operative CBT sessions within the first two months after surgery, starting 2-3 weeks post-surgery. Additionally, an optional HIPAA-compliant mobile app, SMART-MH, may be used to deliver the same CBT content and allow electronic completion of patient-reported outcome questionnaires. Throughout the study, participants will complete assessments of anxiety, depression, pain catastrophizing, and overall mental health before surgery and again at 6 weeks, 6 months, and 1 year after surgery. These evaluations use validated tools including the Beck Anxiety Inventory, Beck Depression Inventory, PROMIS short forms, and the Scoliosis Research Society questionnaire-22 revised. Researchers will also collect sociodemographic data and monitor patient-reported outcomes to measure the intervention’s impact on psychological and physical recovery over time.

CONDITIONS

Brief Title

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Who Can Participate

Age: 10Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of scoliosis prior to age 20
  • Healthy, non-obese individuals aged 10 to 19 years
  • Diagnosis of idiopathic scoliosis
  • Scheduled for elective posterior spinal fusion surgery
Not Eligible

You will not qualify if you...

  • Diagnosis of scoliosis after age 20
  • Permanent cognitive impairment
  • Pregnant or breastfeeding women
  • Use of opioids within the last 6 months
  • Liver or kidney diseases
  • Developmental delays

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and initial hospital recovery period

Participants undergo elective posterior spinal fusion surgery for scoliosis and receive immediate post-operative care.

1 hospital stay encompassing surgery and immediate recovery

Behavioral Treatment

Duration - First two months following surgery beginning 2-3 weeks after surgery

Participants in the intervention group receive one pre-operative and three post-operative cognitive behavioral therapy (CBT) sessions aimed at decreasing anxiety and pain. A HIPAA-compliant mobile application may be used as an alternative platform for delivering CBT content and completing questionnaires.

4 sessions total (1 pre-operative session and 3 post-operative sessions)

Post-operative Follow-up

Duration - Up to 1 year after surgery

Participants' mental health, pain, and physical function are assessed at multiple time points following surgery to monitor recovery and outcomes.

Visits at 6 weeks, 6 months, and 1 year post-surgery

Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

L

Leila Mehraban Alvandi, PhD

E

Eric Fornari, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Frequently Asked Questions

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