Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
NCT ID: NCT05774002
Last Updated: 2025-01-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-06
Study Completion Date
2026-10-31
Brief Summary
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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
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Detailed Description
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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 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
Conditions
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Adolescent Idiopathic Scoliosis (AIS)
Mental Health
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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standard of care control groups no psychological intervention
standard of care control groups no psychological intervention
Group Type
NO_INTERVENTION
No interventions assigned to this group
psychological intervention ADAPT
The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model.
Group Type
EXPERIMENTAL
Aims to Decrease Anxiety and Pain Treatment (ADAPT)
Intervention Type
BEHAVIORAL
One pre-operative and 4 post-operative sessions of cognitive behavioral therapy (CBT) treatment in the first two months, beginning 2-3 weeks after surgery, will be completed.
Interventions
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Aims to Decrease Anxiety and Pain Treatment (ADAPT)
One pre-operative and 4 post-operative sessions of cognitive behavioral therapy (CBT) treatment in the first two months, beginning 2-3 weeks after surgery, will be completed.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* Permanent cognitive impairment
* Pregnant or breastfeeding women
* Use of opioids in the last 6 months
* Liver or renal diseases and developmental delays
Minimum Eligible Age
10 Years
Maximum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Albert Einstein College of Medicine
OTHER
Sponsor Role
collaborator
Montefiore Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Eric D Fornari, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2022-14525
Identifier Type: -
Identifier Source: org_study_id
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NA
Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis
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UNKNOWN
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Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis
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Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod
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Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft
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UNKNOWN
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