NCT05774002

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

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

Detailed description

Mental health is a critical part of an adolescent's overall health and well-being. Mental health encompasses adolescents' mental, emotional, and behavioral well-being. It affects how adolescents think, feel, and act. It also plays a role in how adolescents handle stress, relate to others, and make healthy choices. Studies show that pre-pandemic adolescents were challenged with an increasing rate of depression and anxiety, and this has only been compounded by the pandemic, with evidence showing this number has at least doubled. It has also been reported that in adolescents, psychosocial risk factors including anxiety and depressive indicators, sleep disorder and low self-efficacy are associated with poorer pain and health-related outcomes at both short- and long-term follow-up after major orthopaedic surgeries. AIS is the most common spinal deformity among children and adolescents and the most frequent reason for corrective spinal fusion (SF). Children who are diagnosed with AIS have an increased risk of experiencing painful procedures, as well as diagnostic tests and treatment. While primary management of AIS includes non-surgical interventions, surgical intervention is indicated for severe and progressive deformities. It has been reported that patients with psychological disorders account for higher rates of acute pain and are more likely to develop chronic post-surgical pain (CPSP) than the general population. Moreover, known psychological risk factors for CPSP are acute postoperative pain and high/excessive consumption of opioid analgesics in the acute postoperative setting that leads to delayed recovery and hospital discharge. In recent years, several pre-surgical psychological risk factors for chronic post-surgical pain have been identified. These include negative affective constructs, such as anxiety symptoms, depressive symptoms, pain catastrophizing and general psychological distress. Furthermore, it has been reported that 40% of children and adolescents with chronic post-surgical pain experience disruptions with school attendance, involvement in hobbies, appetite, and sleep disorders. Similar research demonstrated that up to 50% of children and adolescents with idiopathic scoliosis experience persistent pain and analgesic use 1 year after spinal fusion surgery and those with preexisting pain prior to surgery were 2.6 times more likely to experience post-surgical pain. Data suggests a "pain vulnerable" characteristic that develops in childhood and may reflect a neurobiological mechanism such as central pain augmentation. Pain complications and opioid use/misuse frequently begin in adolescence and place individuals at risk for lifetime problems. Consequently, prevention strategies addressing these health crises must address risk during this vulnerable developmental period. Moreover, opioids are part of pain management after these surgeries, and opioid-naïve youth undergoing surgery are at higher risk for rising persistent opioid usage over the subsequent year. Adolescents undergoing major surgeries urgently need effective therapies to assess and address underlying anxiety and depression, manage pain, and to reduce exposure to opioids. Therefore, pre-operative cognitive behavioral interventions followed by targeted interventions throughout the post-operative period should make up an important component of preparation for children and adolescents scheduled for major orthopaedic procedures. The overarching hypothesis is that preoperative identification and treatment of adolescents with anxiety and/or depression will allow for improvement of short-term and long-term physical and mental health related outcomes following spinal fusion surgery. Psychological intervention of adolescents prior to major surgical procedures using behavioral strategies (e.g., relaxation and training in coping skills) has been beneficial in reducing postoperative anxiety and distress and generally improving psychological adjustment. There is strong evidence that demonstrates interventions that target baseline psychosocial risk factors will improve physical and psychological outcomes in children and adolescents. There are few studies available to determine the effectiveness of cognitive behavioral interventions for reducing adolescents' postoperative anxiety and pain following spinal fusion surgery for scoliosis, and whether effectiveness depends on racial, socio-economic factors, preoperative mental health disorders, and/or age. Results of the proposed research will provide foundational knowledge and data that is currently lacking and will demonstrate feasibility and yield of the proposed intervention. The research team anticipates these results will have a profound impact on both understanding of patient's mental health and well-being and allow for development of reliable and reproducible mechanisms by which the research team can intervene to address. Integration of behavioral health within the standard orthopaedic care model will provide adolescents with increased access to the most effective treatment for pain management, de-stigmatize mental health concerns, increase patient/family buy-in, and offer a systematic and evidence-based approach to treating underlying anxiety, depression, and pain. As a result, the physical, mental, functional outcomes, and overall well-being of this adolescent population can be improved following spinal fusion surgery. UPDATE: An amendment adds an optional HIPAA-compliant mobile application (SMART-MH) as an alternative delivery method for components already approved as part of this study. SMART-MH will provide the same CBT-based psychoeducation content included in the ADAPT intervention and allow participants to complete previously approved PRO questionnaires electronically. No new aims, interventions, assessments, or study procedures are being introduced. The app does not change eligibility, randomization, visit schedules, or risk level. All existing procedures remain available for participants who choose not to use SMART-MH.

Conditions

• Adolescent Idiopathic Scoliosis (AIS)
• Mental Health

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-06
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2023-03-17
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States