Montefiore Medical Center
The Bronx, New York, 10467, United States
Location status: Recruiting
NCT Number: NCT05774002
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
Interested in participating?
Request Info10 year–19 year
All sexes
Interventional
Not applicable
The Bronx, New York, 10467, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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
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.
Time frame: preoperatively
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.
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
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
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
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
Eric Fornari, MD
CONTACT
Leila Mehraban Alvandi, PhD
CONTACT
Montefiore Medical Center
Other
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)
Acronym: PASS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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