Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)
Montefiore Medical Center
120 participants
Oct 6, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria5
- 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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Interventions
One pre-operative and 3 post-operative sessions of cognitive behavioral therapy (CBT) treatment in the first two months, beginning 2-3 weeks after surgery, will be completed. A HIPAA-compliant mobile application (SMART-MH) may be used as alternative platform to deliver the same ADAPT CBT-based psychoeducation content and allow participants to complete the PRO questionnaires electronically.
Locations(1)
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NCT05774002