Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Adolescent Idiopathic Scoliosis (AIS); Mental Health

Treatments: Behavioral: Aims to Decrease Anxiety and Pain Treatment (ADAPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05774002

2022-14525

Details and patient eligibility

About

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

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

standard of care control groups no psychological intervention

No Intervention group

Description:

standard of care control groups no psychological intervention

psychological intervention ADAPT

Experimental group

Description:

The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model.

Treatment:

Behavioral: Aims to Decrease Anxiety and Pain Treatment (ADAPT)