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NCT05774002 · Montefiore Medical Center

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

(PASS)

What this study is about

Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the investigators have designed a forward-looking randomly assigned clinical trial (2:1) study for 45 Adolescent Idiopathic Scoliosis (AIS) patients, 10-19 years of age.

View original scientific 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 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.

Interventions

BEHAVIORAL

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 measures

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 anxiety, preoperatively to postoperatively, will be assessed using the Beck Anxiety Inventory (BAI). The BAI is a 21-item, self-report tool used to assess anxiety severity over the prior week. Participants are asked to rate their anxiety symptoms using a scale of 0-3 which correlate to "Not at all," "Mildly," "Moderately," or "Severely," respectively. Scores are then totaled yielding an overall range of 0-63. Scores of 0-7 are indicative of low anxiety; 8-15 mild anxiety; 16-25 moderate anxiety; and scores \>=26 are indicative of severe anxiety. Results will be summarized by study arm using basic descriptive statistics.

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 from baseline in catastrophic thinking associated with pain will be assessed using the Pain Catastrophizing Scale for Children (PCS-C), preoperatively and postoperatively. The 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 provided using a Likert-type rating scale, ranging from 0 (not at all) to 4 (extremely), yielding an overall possible scoring range of 0-52. A higher score on is indicative of a higher level of pain catastrophizing.

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 depression, preoperatively to postoperatively, will be assessed using the Beck Depression Inventory (BDI-II). The BDI-II is a 21-item, self-report tool used to assess depression severity over the prior two weeks. Participants are asked to rate their anxiety symptoms using a scale of 0-3 which correlate to "Not at all," "Mildly," "Moderately," or "Severely," respectively. Scores are then totaled yielding an overall range of 0-63. Scores of 0-13 are indicative of minimal depression; 14-19 mild depression; 20-28 moderate depression; and scores \>=29 are indicative of severe depression. Results will be summarized by study arm using basic descriptive statistics.

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, preoperatively to postoperatively, will be assessed using the PROMIS short form for Depression. This form consists of a set of person-centered measures that evaluate mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a general population mean of 50 and standard deviation of 10 in a reference sample. PROMIS items consist of a statement (e.g., "I felt alone") with five response options: Never; Rarely; Sometimes; Often; and Always. A PROMIS depression score \<50 is considered normal.

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

Assessment of changes in Mental health, preoperatively to postoperatively, will also be assessed using the PROMIS Version 1 short form for Anxiety. This form consists of a set of person-centered measures that evaluate mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a general population mean of 50 and standard deviation of 10 in a reference sample. PROMIS items consist of a statement (e.g., "I feel fearful") five response options: Never; Rarely; Sometimes; Often; and Always. A PROMIS anxiety score of \<50 is considered normal.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

Where

  • The Bronx, New York

Collaborators

Albert Einstein College of Medicine

Related conditions & keywords

Adolescent Idiopathic Scoliosis (AIS)Mental Health

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations

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Study locations

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RECRUITING

The Bronx

New York

Location available

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Adolescent Idiopathic Scoliosis (AIS) Treatment in The Bronx?

Join others in New York exploring innovative treatment options through clinical research

Adolescent Idiopathic Scoliosis (AIS) Treatment Options in The Bronx, New York

If you're searching for Adolescent Idiopathic Scoliosis (AIS) treatment in The Bronx, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in The Bronx and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Adolescent Idiopathic Scoliosis (AIS). All study-related care is provided at no cost to participants.

Local Sites
1 locations in New York
Now Enrolling
Up to 120 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Adolescent Idiopathic Scoliosis (AIS)?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Adolescent Idiopathic Scoliosis (AIS)

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Adolescent Idiopathic Scoliosis (AIS) Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05774002. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.