Actively Recruiting

Phase Not Applicable
Age: 10Years - 19Years
All Genders
NCT05774002

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

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

120

Participants Needed

1

Research Sites

260 weeks

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

Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the investigators have designed a prospective randomized clinical trial (2:1) study for 45 Adolescent Idiopathic Scoliosis (AIS) patients, 10-19 years of age. This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome (PRO) measures. The investigators will implement and test a structured perioperative psychological intervention program, based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which was developed based on evidence-based cognitive behavioral therapy (CBT) protocols for the management of pediatric pain and childhood anxiety disorders

CONDITIONS

Official 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 aged 10-19 years, with a diagnosis of idiopathic scoliosis
  • Undergoing 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 in the last 6 months
  • Liver or renal diseases
  • Developmental delays

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

E

Eric Fornari, MD

CONTACT

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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