NCT05774002 Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
| NCT ID | NCT05774002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Adolescent Idiopathic Scoliosis (AIS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-10-06 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-10-06 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Eric D Fornari, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05774002 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 19 Years, studying Adolescent Idiopathic Scoliosis (AIS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05774002 currently recruiting?
Yes, NCT05774002 is actively recruiting participants. Contact the research team at lalvandi@montefiore.org for enrollment information.
Where is the NCT05774002 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05774002 clinical trial?
NCT05774002 is sponsored by Montefiore Medical Center. The principal investigator is Eric D Fornari, MD at Montefiore Medical Center. The trial plans to enroll 120 participants.