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 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

Study Overview

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

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.

• 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
    • The 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of changes in Anxiety using the Beck Anxiety Inventory (BAI)	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.	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)	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.	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 using the Beck Depression Inventory (BDI-II)	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.	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 using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form for Depression	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.	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 using the PROMIS Version 1 short form for Anxiety	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.	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
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Vranceanu AM, Barsky A, Ring D. Psychosocial aspects of disabling musculoskeletal pain. J Bone Joint Surg Am. 2009 Aug;91(8):2014-8. doi: 10.2106/JBJS.H.01512.
• DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med. 2000 Jul 24;160(14):2101-7. doi: 10.1001/archinte.160.14.2101.
• Dunn J, Henrikson NB, Morrison CC, Blasi PR, Nguyen M, Lin JS. Screening for Adolescent Idiopathic Scoliosis: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Jan 9;319(2):173-187. doi: 10.1001/jama.2017.11669.
• Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.
• Connelly M, Fulmer RD, Prohaska J, Anson L, Dryer L, Thomas V, Ariagno JE, Price N, Schwend R. Predictors of postoperative pain trajectories in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2014 Feb 1;39(3):E174-81. doi: 10.1097/BRS.0000000000000099.
• Rabbitts JA, Zhou C, Groenewald CB, Durkin L, Palermo TM. Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery. Pain. 2015 Nov;156(11):2383-2389. doi: 10.1097/j.pain.0000000000000281.
• Rabbitts JA, Groenewald CB, Tai GG, Palermo TM. Presurgical psychosocial predictors of acute postsurgical pain and quality of life in children undergoing major surgery. J Pain. 2015 Mar;16(3):226-34. doi: 10.1016/j.jpain.2014.11.015. Epub 2014 Dec 22.
• Page MG, Campbell F, Isaac L, Stinson J, Katz J. Parental risk factors for the development of pediatric acute and chronic postsurgical pain: a longitudinal study. J Pain Res. 2013 Sep 30;6:727-41. doi: 10.2147/JPR.S51055. eCollection 2013.
• Rabbitts JA, Zhou C, Narayanan A, Palermo TM. Longitudinal and Temporal Associations Between Daily Pain and Sleep Patterns After Major Pediatric Surgery. J Pain. 2017 Jun;18(6):656-663. doi: 10.1016/j.jpain.2017.01.004. Epub 2017 Jan 26.
• Chidambaran V, Ding L, Moore DL, Spruance K, Cudilo EM, Pilipenko V, Hossain M, Sturm P, Kashikar-Zuck S, Martin LJ, Sadhasivam S. Predicting the pain continuum after adolescent idiopathic scoliosis surgery: A prospective cohort study. Eur J Pain. 2017 Aug;21(7):1252-1265. doi: 10.1002/ejp.1025. Epub 2017 Mar 27.
• Palermo TM, Eccleston C, Lewandowski AS, de C Williams AC, Morley S. Randomized controlled trials of psychological therapies for management of chronic pain in children and adolescents: an updated meta-analytic review. Pain. 2010 Mar;148(3):387-397. doi: 10.1016/j.pain.2009.10.004. Epub 2009 Nov 11.
• Goodman JE, McGrath PJ. The epidemiology of pain in children and adolescents: a review. Pain. 1991 Sep;46(3):247-264. doi: 10.1016/0304-3959(91)90108-A. No abstract available.
• Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
• Vranceanu AM, Bachoura A, Weening A, Vrahas M, Smith RM, Ring D. Psychological factors predict disability and pain intensity after skeletal trauma. J Bone Joint Surg Am. 2014 Feb 5;96(3):e20. doi: 10.2106/JBJS.L.00479.
• Marques de Miranda D, da Silva Athanasio B, Sena Oliveira AC, Simoes-E-Silva AC. How is COVID-19 pandemic impacting mental health of children and adolescents? Int J Disaster Risk Reduct. 2020 Dec;51:101845. doi: 10.1016/j.ijdrr.2020.101845. Epub 2020 Sep 10.
• Rabbitts JA, Fisher E, Rosenbloom BN, Palermo TM. Prevalence and Predictors of Chronic Postsurgical Pain in Children: A Systematic Review and Meta-Analysis. J Pain. 2017 Jun;18(6):605-614. doi: 10.1016/j.jpain.2017.03.007. Epub 2017 Mar 29.
• Rabbitts JA, Palermo TM, Zhou C, Meyyappan A, Chen L. Psychosocial Predictors of Acute and Chronic Pain in Adolescents Undergoing Major Musculoskeletal Surgery. J Pain. 2020 Nov-Dec;21(11-12):1236-1246. doi: 10.1016/j.jpain.2020.02.004. Epub 2020 Jun 15.
• Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4.
• Rabbitts JA, Aaron RV, Fisher E, Lang EA, Bridgwater C, Tai GG, Palermo TM. Long-Term Pain and Recovery After Major Pediatric Surgery: A Qualitative Study With Teens, Parents, and Perioperative Care Providers. J Pain. 2017 Jul;18(7):778-786. doi: 10.1016/j.jpain.2017.02.423. Epub 2017 Feb 21.
• Parsons B, Schaefer C, Mann R, Sadosky A, Daniel S, Nalamachu S, Stacey BR, Nieshoff EC, Tuchman M, Anschel A. Economic and humanistic burden of post-trauma and post-surgical neuropathic pain among adults in the United States. J Pain Res. 2013 Jun 17;6:459-69. doi: 10.2147/JPR.S44939. Print 2013.
• Esteve R, Marquina-Aponte V, Ramirez-Maestre C. Postoperative pain in children: association between anxiety sensitivity, pain catastrophizing, and female caregivers' responses to children's pain. J Pain. 2014 Feb;15(2):157-68.e1. doi: 10.1016/j.jpain.2013.10.007. Epub 2013 Oct 27.
• Katz J, Weinrib A, Fashler SR, Katznelzon R, Shah BR, Ladak SS, Jiang J, Li Q, McMillan K, Santa Mina D, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V, Grant D, Roche-Nagle G, Cleary SP, Hofer SO, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O'Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015 Oct 12;8:695-702. doi: 10.2147/JPR.S91924. eCollection 2015.
• Powers SW. Empirically supported treatments in pediatric psychology: procedure-related pain. J Pediatr Psychol. 1999 Apr;24(2):131-45. doi: 10.1093/jpepsy/24.2.131.
• Pielech M, Ryan M, Logan D, Kaczynski K, White MT, Simons LE. Pain catastrophizing in children with chronic pain and their parents: proposed clinical reference points and reexamination of the Pain Catastrophizing Scale measure. Pain. 2014 Nov;155(11):2360-7. doi: 10.1016/j.pain.2014.08.035. Epub 2014 Aug 29.
• Meherali S, Punjani N, Louie-Poon S, Abdul Rahim K, Das JK, Salam RA, Lassi ZS. Mental Health of Children and Adolescents Amidst COVID-19 and Past Pandemics: A Rapid Systematic Review. Int J Environ Res Public Health. 2021 Mar 26;18(7):3432. doi: 10.3390/ijerph18073432.
• Cunningham NR, Nelson S, Jagpal A, Moorman E, Farrell M, Pentiuk S, Kashikar-Zuck S. Development of the Aim to Decrease Anxiety and Pain Treatment for Pediatric Functional Abdominal Pain Disorders. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):16-20. doi: 10.1097/MPG.0000000000001714.
• Kain ZN, Mayes LC, Caramico LA. Preoperative preparation in children: a cross-sectional study. J Clin Anesth. 1996 Sep;8(6):508-14. doi: 10.1016/0952-8180(96)00115-8.
• Raymond C, Provencher J, Bilodeau-Houle A, Leclerc J, Marin MF. A longitudinal investigation of psychological distress in children during COVID-19: the role of socio-emotional vulnerability. Eur J Psychotraumatol. 2022 Jan 24;13(1):2021048. doi: 10.1080/20008198.2021.2021048. eCollection 2022.
• Bitsko RH, Claussen AH, Lichstein J, Black LI, Jones SE, Danielson ML, Hoenig JM, Davis Jack SP, Brody DJ, Gyawali S, Maenner MJ, Warner M, Holland KM, Perou R, Crosby AE, Blumberg SJ, Avenevoli S, Kaminski JW, Ghandour RM; Contributor. Mental Health Surveillance Among Children - United States, 2013-2019. MMWR Suppl. 2022 Feb 25;71(2):1-42. doi: 10.15585/mmwr.su7102a1.
• Ghandour RM, Sherman LJ, Vladutiu CJ, Ali MM, Lynch SE, Bitsko RH, Blumberg SJ. Prevalence and Treatment of Depression, Anxiety, and Conduct Problems in US Children. J Pediatr. 2019 Mar;206:256-267.e3. doi: 10.1016/j.jpeds.2018.09.021. Epub 2018 Oct 12.
• Bitsko RH, Holbrook JR, Ghandour RM, Blumberg SJ, Visser SN, Perou R, Walkup JT. Epidemiology and Impact of Health Care Provider-Diagnosed Anxiety and Depression Among US Children. J Dev Behav Pediatr. 2018 Jun;39(5):395-403. doi: 10.1097/DBP.0000000000000571.
• Hutchins HJ, Barry CM, Wanga V, Bacon S, Njai R, Claussen AH, Ghandour RM, Lebrun-Harris LA, Perkins K, Robinson LR. Perceived Racial/Ethnic Discrimination, Physical and Mental Health Conditions in Childhood, and the Relative Role of Other Adverse Experiences. Advers Resil Sci. 2022;3(2):181-194. doi: 10.1007/s42844-022-00063-z.
• Zale EL, Lange KL, Fields SA, Ditre JW. The relation between pain-related fear and disability: a meta-analysis. J Pain. 2013 Oct;14(10):1019-30. doi: 10.1016/j.jpain.2013.05.005. Epub 2013 Jul 11.
• Page MG, Stinson J, Campbell F, Isaac L, Katz J. Pain-related psychological correlates of pediatric acute post-surgical pain. J Pain Res. 2012;5:547-58. doi: 10.2147/JPR.S36614. Epub 2012 Nov 12.
• Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.
• Ramo BA, Collins-Jones TL, Thornberg D, Klinkerman L, Rathjen K, Jo CH. Pain Catastrophizing Influences Preoperative and Postoperative Patient-Reported Outcomes in Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2022 Nov 2;104(21):1859-1868. doi: 10.2106/JBJS.22.00258. Epub 2022 Aug 18.
• DiNapoli T.P., Bleiwas K.B., An Economic and Demographic Snapshot of the Bronx. Office of the New York State Comptroller. https://www.osc.state.ny.us/files/reports/osdc/pdf/report-4-2019.pdf
• Nelson S, Cunningham N. The Impact of Posttraumatic Stress Disorder on Clinical Presentation and Psychosocial Treatment Response in Youth with Functional Abdominal Pain Disorders: An Exploratory Study. Children (Basel). 2020 Jun 2;7(6):56. doi: 10.3390/children7060056.
• Kalomiris AE, Ely SL, Love SC, Mara CA, Cunningham NR. Child-Focused Cognitive Behavioral Therapy for Pediatric Abdominal Pain Disorders Reduces Caregiver Anxiety in Randomized Clinical Trial. J Pain. 2022 May;23(5):810-821. doi: 10.1016/j.jpain.2021.12.001. Epub 2021 Dec 11.
• Children's Mental Health: Understanding an Ongoing Public Health Concern, CDC , https://www.cdc.gov/childrensmentalhealth/data.html
• Davidson F, Snow S, Hayden JA, Chorney J. Psychological interventions in managing postoperative pain in children: a systematic review. Pain. 2016 Sep;157(9):1872-1886. doi: 10.1097/j.pain.0000000000000636.
• Charette S, Fiola JL, Charest MC, Villeneuve E, Theroux J, Joncas J, Parent S, Le May S. Guided Imagery for Adolescent Post-spinal Fusion Pain Management: A Pilot Study. Pain Manag Nurs. 2015 Jun;16(3):211-20. doi: 10.1016/j.pmn.2014.06.004. Epub 2014 Nov 6.
• VanDenKerkhof EG, Peters ML, Bruce J. Chronic pain after surgery: time for standardization? A framework to establish core risk factor and outcome domains for epidemiological studies. Clin J Pain. 2013 Jan;29(1):2-8. doi: 10.1097/AJP.0b013e31824730c2.
• Perry M, Starkweather A, Baumbauer K, Young E. Factors Leading to Persistent Postsurgical Pain in Adolescents Undergoing Spinal Fusion: An Integrative Literature Review. J Pediatr Nurs. 2018 Jan-Feb;38:74-80. doi: 10.1016/j.pedn.2017.10.013. Epub 2017 Nov 13.
• Basques BA, Bohl DD, Golinvaux NS, Smith BG, Grauer JN. Patient factors are associated with poor short-term outcomes after posterior fusion for adolescent idiopathic scoliosis. Clin Orthop Relat Res. 2015 Jan;473(1):286-94. doi: 10.1007/s11999-014-3911-4. Epub 2014 Sep 9.
• Twycross AM, Williams AM, Finley GA. Surgeons' aims and pain assessment strategies when managing paediatric post-operative pain: A qualitative study. J Child Health Care. 2015 Dec;19(4):513-23. doi: 10.1177/1367493514527022. Epub 2014 Apr 11.
• Weinrib AZ, Azam MA, Birnie KA, Burns LC, Clarke H, Katz J. The psychology of chronic post-surgical pain: new frontiers in risk factor identification, prevention and management. Br J Pain. 2017 Nov;11(4):169-177. doi: 10.1177/2049463717720636. Epub 2017 Jul 12.
• Katz J, Buis T, Cohen L. Locked out and still knocking: predictors of excessive demands for postoperative intravenous patient-controlled analgesia. Can J Anaesth. 2008 Feb;55(2):88-99. doi: 10.1007/BF03016320.
• Voepel-Lewis T, Caird MS, Tait AR, Farley FA, Li Y, Malviya S, Hassett A, Weber M, Currier E, de Sibour T, Clauw DJ. A cluster of high psychological and somatic symptoms in children with idiopathic scoliosis predicts persistent pain and analgesic use 1 year after spine fusion. Paediatr Anaesth. 2018 Oct;28(10):873-880. doi: 10.1111/pan.13467.
• Groenewald CB, Law EF, Fisher E, Beals-Erickson SE, Palermo TM. Associations Between Adolescent Chronic Pain and Prescription Opioid Misuse in Adulthood. J Pain. 2019 Jan;20(1):28-37. doi: 10.1016/j.jpain.2018.07.007. Epub 2018 Aug 9.
• Perry M. "I thought I was going to die": A meta-synthesis exploring pediatric pain after scoliosis surgery. Int J Orthop Trauma Nurs. 2018 Nov;31:5-12. doi: 10.1016/j.ijotn.2018.09.001. Epub 2018 Sep 6. No abstract available.
• LaMontagne LL, Hepworth JT, Cohen F, Salisbury MH. Cognitive-behavioral intervention effects on adolescents' anxiety and pain following spinal fusion surgery. Nurs Res. 2003 May-Jun;52(3):183-90. doi: 10.1097/00006199-200305000-00008.
• Johnson JE. Effects of accurate expectations about sensations on the sensory and distress components of pain. J Pers Soc Psychol. 1973 Aug;27(2):261-75. doi: 10.1037/h0034767. No abstract available.
• Johnson JE, Fieler VK, Wlasowicz GS, Mitchell ML, Jones LS. The effects of nursing care guided by self-regulation theory on coping with radiation therapy. Oncol Nurs Forum. 1997 Jul;24(6):1041-50.
• LaMontagne LL. Bolstering personal control in child patients through coping interventions. Pediatr Nurs. 1993 May-Jun;19(3):235-7.
• Wall LB, Wright M, Samora J, Bae DS, Steinman S, Goldfarb CA; CoULD Study Group. Social Deprivation and Congenital Upper Extremity Differences-An Assessment Using PROMIS. J Hand Surg Am. 2021 Feb;46(2):114-118. doi: 10.1016/j.jhsa.2020.08.017. Epub 2020 Oct 21.
• Richard HM, Cerza SP, De La Rocha A, Podeszwa DA. Preoperative mental health status is a significant predictor of postoperative outcomes in adolescents treated with hip preservation surgery. J Child Orthop. 2020 Aug 1;14(4):259-265. doi: 10.1302/1863-2548.14.200013.
• Richard HM, Nguyen DC, Podeszwa DA, De La Rocha A, Sucato DJ. Perioperative Interdisciplinary Intervention Contributes to Improved Outcomes of Adolescents Treated With Hip Preservation Surgery. J Pediatr Orthop. 2018 May/Jun;38(5):254-259. doi: 10.1097/BPO.0000000000000816.
• Baldus C, Bridwell K, Harrast J, Shaffrey C, Ondra S, Lenke L, Schwab F, Mardjetko S, Glassman S, Edwards C 2nd, Lowe T, Horton W, Polly D Jr. The Scoliosis Research Society Health-Related Quality of Life (SRS-30) age-gender normative data: an analysis of 1346 adult subjects unaffected by scoliosis. Spine (Phila Pa 1976). 2011 Jun 15;36(14):1154-62. doi: 10.1097/BRS.0b013e3181fc8f98.
• Climent JM, Bago J, Ey A, Perez-Grueso FJ, Izquierdo E. Validity of the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire. Spine (Phila Pa 1976). 2005 Mar 15;30(6):705-9. doi: 10.1097/01.brs.0000155408.76606.8f.
• Carreon LY, Sanders JO, Polly DW, Sucato DJ, Parent S, Roy-Beaudry M, Hopkins J, McClung A, Bratcher KR, Diamond BE; Spinal Deformity Study Group. Spinal appearance questionnaire: factor analysis, scoring, reliability, and validity testing. Spine (Phila Pa 1976). 2011 Aug 15;36(18):E1240-4. doi: 10.1097/BRS.0b013e318204f987.
• Correia, H (2010). PROMIS Statistical Center. Northwestern University. PROMIS Translation Methodology
• Rabbitts JA, Zhou C, de la Vega R, Aalfs H, Murray CB, Palermo TM. A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial. Trials. 2021 Jul 30;22(1):506. doi: 10.1186/s13063-021-05421-3.
• Sockalingam S, Leung SE, Ma C, Hawa R, Wnuk S, Dash S, Jackson T, Cassin SE. The Impact of Telephone-Based Cognitive Behavioral Therapy on Mental Health Distress and Disordered Eating Among Bariatric Surgery Patients During COVID-19: Preliminary Results from a Multisite Randomized Controlled Trial. Obes Surg. 2022 Jun;32(6):1884-1894. doi: 10.1007/s11695-022-05981-6. Epub 2022 Feb 25.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

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 (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; Anesthesia and Analgesia; Analgesia
• 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