Recruiting

Observational Study

Sponsor:

Montefiore Medical Center

Code:

NCT05774002

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Mental Health

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Not accepted

Interventions

Aims to Decrease Anxiety and Pain Treatment (ADAPT)

Study Details

Brief 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

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Mental Health

Study ID

NCT05774002

Start date

Oct 6, 2023

Status verified date

Feb, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: standard of care control groups no psychological intervention

standard of care control groups no psychological intervention

experimental: psychological intervention ADAPT

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

Interventions

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.

Primary outcome measure

  • Assessment of changes in Anxiety using the Beck Anxiety Inventory (BAI) [ Time Frame: preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group ]
  • Assessment of changes in Pain Catastrophizing Scale for Children (PCS-C) [ Time Frame: preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group ]
  • Assessment of changes in Depression using the Beck Depression Inventory (BDI-II) [ Time Frame: preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group ]
  • Assessment of changes in Mental health using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form for Depression [ Time Frame: preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group ]
  • Assessment of changes in Mental health using the PROMIS Version 1 short form for Anxiety [ Time Frame: preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group ]

Central Contacts and Locations

Central contacts

Leila Mehraban Alvandi, PhD

347-419-4226lalvandi@montefiore.org

Eric Fornari, MD

718-920-5532EFORNARI@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Leila Mehraban Alvandi, PhD

718-920-2266lalvandi@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-03-02.