Psychological assessment for adolescents with scoliosis undergoing surgery
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)
This study is testing a new program to help reduce anxiety and pain for teenagers with scoliosis who are having spinal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 10 Years to 19 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05774002 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adolescents aged 10-19 years with a diagnosis of idiopathic scoliosis who are undergoing elective posterior spinal fusion.
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.
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 performed: Other studies have shown success with psychological interventions for managing pain and anxiety in pediatric populations, suggesting potential for this approach.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.