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HIPAA Compliant
ISO 27001 Certified

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 21 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 interventions 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

Research Team

L

Leila Mehraban Alvandi, PhD

E

Eric Fornari, MD

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