Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Recruiting now · Not applicable

Conditions studied: Adolescent Idiopathic Scoliosis (AIS), Mental Health

In brief

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

Key facts

Study ID

NCT05774002

Run by

Montefiore Medical Center

People needed

120

Starts

2023-10-06

Expected to finish

2028-10-01

Last updated by the study team

2026-03-02

Who can join

Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 and developmental delays

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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