Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774002
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-02-17
Brief Title:
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management PASS
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASS
Brief Summary:
Working in partnership with Montefiore-Einsteins Department of Translational Psychiatry the study team investigators have designed a prospective randomized clinical trial 21 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
Detailed Description:
Working in partnership with Montefiore-Einsteins Department of Translational Psychiatry the investigators have designed a prospective randomized clinical trial 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None