Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-19
SponsorMontefiore Medical Center
About this trial
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
Qualifiers
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
Disqualifiers
Diagnosis of scoliosis after age 20
Permanent cognitive impairment
Pregnant or breastfeeding women
Use of opioids in the last 6 months
Trial design
Treatments tested in this trial
- Aims to Decrease Anxiety and Pain Treatment (ADAPT)
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Montefiore Medical Center
Lead sponsor
Albert Einstein College of Medicine
Collaborator
Source ClinicalTrials.gov