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Recruiting NCT05774002

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Trial Parameters

Condition Adolescent Idiopathic Scoliosis (AIS)
Sponsor Montefiore Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 10 Years
Max Age 19 Years
Start Date 2023-10-06
Completion 2028-10
Interventions
Aims to Decrease Anxiety and Pain Treatment (ADAPT)

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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