Psychological assessment for adolescents with scoliosis undergoing surgery
Official title: Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)
Run by Montefiore Medical Center · NCT05774002 · Data updated 2026-11-12
This study is testing a new program to help reduce anxiety and pain for teenagers with scoliosis who are having spinal surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 19 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | October 6, 2023 |
| Main results expected | October 2028 |
| Study ends | October 2028 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT05774002 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adolescents aged 10-19 years with a diagnosis of idiopathic scoliosis who are undergoing elective posterior spinal fusion.
✕Probably not a fit
Patients diagnosed with scoliosis after age 20, those with permanent cognitive impairment, or those with certain medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial involves a partnership with Montefiore-Einstein's Department of Translational Psychiatry to assess the mental health, pain, and functional outcomes of adolescents with Adolescent Idiopathic Scoliosis (AIS) undergoing elective spinal surgery. The study will include a baseline assessment using validated patient-reported outcome measures and will implement a structured psychological intervention program called Aim to Decrease Anxiety and Pain Treatment (ADAPT), which is based on cognitive behavioral therapy protocols. The trial aims to evaluate the effectiveness of this intervention in reducing anxiety and pain during the perioperative period.
Why it matters
Potential benefit: If successful, this study could improve mental health and pain management for adolescents undergoing scoliosis surgery.
How similar studies have gone: Other studies have shown success with psychological interventions for managing pain and anxiety in pediatric populations, suggesting potential for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Montefiore Medical Center
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Eric D Fornari, MD — Montefiore Medical Center
- Study coordinator: Leila Mehraban Alvandi, PhD
- Email: lalvandi@montefiore.org
- Phone: 347-419-4226
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.