Adolescent Idiopathic Scoliosis (AIS)PASSNCT05774002
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
A study testing Aims to Decrease Anxiety and Pain Treatment (ADAPT) in people with Adolescent Idiopathic Scoliosis (AIS) and Mental Health, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS), Mental Health
- What is being tested?
- Aims to Decrease Anxiety and Pain Treatment (ADAPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Leila Mehraban Alvandi, PhD, 718-920-2266, lalvandi@montefiore.org
About this study
Official title: 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
Read the 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.
- Being tested
- Aims to Decrease Anxiety and Pain Treatment (ADAPT)
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aims to Decrease Anxiety and Pain Treatment (ADAPT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| standard of care control groups no psychological intervention | No intervention | standard of care control groups no psychological intervention |
| psychological intervention ADAPT | Experimental | The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model. Receives: Behavioral: Aims to Decrease Anxiety and Pain Treatment (ADAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start6 Oct 2023
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine
- Responsible party
- Sponsor
- Investigators
- Eric D Fornari, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774002
- Sponsor's protocol ID
- 2022-14525
- Acronym
- PASS
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32929399Meherali 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.
PubMed 33810225Raymond 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.
PubMed 35087645DiMatteo 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.
PubMed 10904452Bitsko 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.
PubMed 35202359Ghandour 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.
PubMed 30322701Bitsko 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.
PubMed 29688990Hutchins 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.
PubMed 37181947Zale 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.
PubMed 23850095Page 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.
PubMed 23204864Rabbitts 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.
PubMed 25540939Batoz 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.
PubMed 28077537Connelly 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.
PubMed 24173016Rabbitts 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.
PubMed 26381701Rabbitts 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.
PubMed 32553622
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)
- ClinicalTrials.gov ID
- NCT05774002
- Acronym / sponsor ID
- PASS / 2022-14525
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 randomization
| Arm | Type | Receives |
|---|---|---|
| standard of care control groups no psychological intervention | No intervention | –standard of care control groups no psychological intervention |
| psychological intervention ADAPT | Experimental | Behavioral: Aims to Decrease Anxiety and Pain Treatment (ADAPT)The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | psychological intervention ADAPT |
Primary outcome
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.
6 secondary outcomes
Assessment of changes in pain preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
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
Sociodemographic factors using Child Opportunity Index (COI)
Time frame: preoperatively
Assessment of changes in mental health preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
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 self image score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
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 Function score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
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 Satisfaction with management score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 32929399Marques 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.
- Background: PubMed 33810225Meherali 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.
- Background: PubMed 35087645Raymond 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.
- Background: PubMed 10904452DiMatteo 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.
- Background: PubMed 35202359Bitsko 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.
- Background: PubMed 30322701Ghandour 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.
- Background: PubMed 29688990Bitsko 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.
- Background: PubMed 37181947Hutchins 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.
- Background: PubMed 23850095Zale 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.
- Background: PubMed 23204864Page 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.
- Background: PubMed 25540939Rabbitts 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.
- Background: PubMed 28077537Batoz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric D Fornari, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aims to Decrease Anxiety and Pain Treatment (ADAPT) in people with Adolescent Idiopathic Scoliosis (AIS) and Mental Health, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila Mehraban Alvandi, PhD (347-419-4226, lalvandi@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774002, which also lists 64 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.