RECRUITING

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the study team investigators have designed a prospective randomized clinical trial (2:1) study for 45 AIS patients (10-19 yrs.). This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome 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

Official Title

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)

Quick Facts

Study Start:2023-10-06
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05774002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of scoliosis prior to age 20
  2. * Healthy, non-obese aged 10-19 years, with a diagnosis of idiopathic scoliosis, undergoing elective posterior spinal fusion
  1. * Diagnosis of scoliosis after age 20
  2. * Permanent cognitive impairment
  3. * Pregnant or breastfeeding women
  4. * Use of opioids in the last 6 months
  5. * Liver or renal diseases and developmental delays

Contacts and Locations

Study Contact

Leila Mehraban Alvandi, PhD
CONTACT
347-419-4226
lalvandi@montefiore.org
Eric Fornari, MD
CONTACT
718-920-5532
EFORNARI@montefiore.org

Principal Investigator

Eric D Fornari, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Eric D Fornari, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-06
Study Completion Date2026-10

Study Record Updates

Study Start Date2023-10-06
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Adolescent Idiopathic Scoliosis (AIS)
  • Mental Health