Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05774002
Status
Recruiting
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Conditions

  • Adolescent Idiopathic Scoliosis (AIS)
  • Mental Health

Eligibility Criteria

Sex
ALL
Age
10 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Aims to Decrease Anxiety and Pain Treatment (ADAPT) — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Oct 6, 2023
Status verified
Feb 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467
Leila Mehraban Alvandi, PhD
[email protected]
718-920-2266

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