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RECRUITING
NCT05774002
NA

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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

Official title: Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)

Key Details

Gender

All

Age Range

10 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-10-06

Completion Date

2028-10

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

BEHAVIORAL

Aims to Decrease Anxiety and Pain Treatment (ADAPT)

One pre-operative and 3 post-operative sessions of cognitive behavioral therapy (CBT) treatment in the first two months, beginning 2-3 weeks after surgery, will be completed. A HIPAA-compliant mobile application (SMART-MH) may be used as alternative platform to deliver the same ADAPT CBT-based psychoeducation content and allow participants to complete the PRO questionnaires electronically.

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States