Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)

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

Study Overview

• Status: Recruiting
• Conditions: Mental Health; Adolescent Idiopathic Scoliosis (AIS)
• Intervention / Treatment: Behavioral: Aims to Decrease Anxiety and Pain Treatment (ADAPT)

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Fornari, MD; Phone Number: 718-920-5532; Email: EFORNARI@montefiore.org
• Study Contact Backup: Name: Leila Mehraban Alvandi, PhD; Phone Number: 347-419-4226; Email: lalvandi@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Leila Mehraban Alvandi, PhD; Phone Number: 718-920-2266; Email: lalvandi@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of changes in Mental health preoperatively and postoperatively using Generalized Anxiety Disorder (GAD-7)	Assessing Mental health score changes preoperatively and postoperatively using the Generalized Anxiety Disorder (GAD-7) questionnaire. (GAD-7) questionnaire is a seven-item, self-report anxiety questionnaire. The Scores of 0, 1 or 2 are given for experiencing symptoms 'not at all', for 'several days', for 'more than half the days' and for 'nearly every day', respectively. The scores are then totalled and presented from 0 to 21. Scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety, respectively. When screening for an anxiety disorder, a recommended cut-off point for referral for further evaluation is 10 or greater.	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) preoperatively and postoperatively	Pain Catastrophizing Scale for children( PCS-C ) is a 13-item scale One of the main adaptations of the child version of the pain catastrophizing scale is the repetition of the stem "When I have pain, …" at the beginning of each item. Responses for each statement are done using a Likert-type rating scale, ranging from 0 (not at all) to 4 (extremely). A higher score on this scale would indicate a higher level of pain catastrophizing.	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 preoperatively and post postoperatively using the Patient Health Questionnaire (PHQ)-9.	The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders(DSM-IV) criteria as "0" (not at all) to "3" (nearly every day). score of 0-13: no depression. 14-19: mild depression. 20-28: moderate depression. 29-63: severe depression.	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 preoperatively and postoperatively using PROMIS- (Patient-Reported Outcomes Measurement Information System) short form for Depression	PROMIS-short form (Patient-Reported Outcomes Measurement Information System) for Depression is a set of person-centered measures that evaluates mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. PROMIS items consist of a statement (e.g., "I felt alone") with five response options never, rarely, sometimes, often and always. PROMIS depression score of less than 50 consider normal. A score of 50= mean of general population sample	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 preoperatively and postoperatively using PROMIS-(Patient-Reported Outcomes Measurement Information System) v1 short form for Anxiety	PROMIS-short form (Patient-Reported Outcomes Measurement Information System) for anxiety is a set of person-centered measures that evaluates mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. PROMIS items consist of a statement (e.g., "I feel fearful") with five response options never, rarely, sometimes, often and always. PROMIS anxiety score of less than 50 consider normal. A score of 50= mean of general population reference sample	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of changes in pain preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis	The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The pain domain has five questionnaires A score <4 in the SRS-22-r pain domain (1 = severe pain and 5 = pain free) is considered clinically relevant .	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
Sociodemographic factors using Child Opportunity Index (COI)	The Child Opportunity Index (COI) 2.0 measures neighborhood resources and conditions that matter for children's healthy development. Total represents the overall index, while Education represents the education metrics, Health represents the health & environment metrics, and social & economic represents the social & economic metrics. Record sociodemographic factors to assess the impact on treatment adherence and overall outcomes using child opportunity index Child Opportunity Scores are released as metro, state and nationally normed versions. using the nationally normed index conceals within-metro area inequalities because a disproportionate number of neighborhoods are assigned to the "high" and "very high" opportunity levels when referenced to all tracts nationally.	preoperatively
Assessment of changes in mental health preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis	The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The mental health domain has five questionnaires: 5=Best mental health outcome score1=warning score	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 self image score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis	The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The self-image domain has five questionnaires: 5=Best mental health outcome score1=warning score	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 Function score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis	The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The Function domain has 5 questionnaires: 5=Best mental health outcome score, 1=warning score	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 Satisfaction with management score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis	The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The Satisfaction with management domain has 2 questionnaires: 5=Best mental health outcome score1=warning score Are you satisfied with the results of your back management? 5-Very satisfied 4-Satisfied 3-Neither satisfied nor unsatisfied 2-Unsatisfied 1-Very unsatisfied Would you have the same management again if you had the same condition? 5-Definitely yes 4-Probably yes 3-Not sure 2-Probably not 1-Definitely not	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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Eric D Fornari, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2022-14525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No