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Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)

Primary Purpose

Adolescent Idiopathic Scoliosis (AIS), Mental Health

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aims to Decrease Anxiety and Pain Treatment (ADAPT)
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adolescent Idiopathic Scoliosis (AIS)

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of scoliosis prior to age 20 Healthy, non-obese aged 12-19 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    standard of care control groups no psychological intervention

    psychological intervention ADAPT

    Arm Description

    standard of care control groups no psychological intervention

    The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model.

    Outcomes

    Primary Outcome Measures

    Assessment of changes in Mental health preoperatively and postoperatively using Generalized Anxiety Disorder (GAD-7)
    Assessing Mental health score changes preoperatively and postoperatively using the Generalized Anxiety Disorder (GAD-7) questionnaire. (GAD-7) questionnaire is a seven-item, self-report anxiety questionnaire. The Scores of 0, 1 or 2 are given for experiencing symptoms 'not at all', for 'several days', for 'more than half the days' and for 'nearly every day', respectively. The scores are then totalled and presented from 0 to 21. Scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety, respectively. When screening for an anxiety disorder, a recommended cut-off point for referral for further evaluation is 10 or greater.
    Assessment of changes in Pain Catastrophizing Scale for Children (PCS-C) preoperatively and postoperatively
    Pain Catastrophizing Scale for children( 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 done using a Likert-type rating scale, ranging from 0 (not at all) to 4 (extremely). A higher score on this scale would indicate a higher level of pain catastrophizing.
    Assessment of changes in Mental health preoperatively and post postoperatively using the Patient Health Questionnaire (PHQ)-9.
    The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders(DSM-IV) criteria as "0" (not at all) to "3" (nearly every day). score of 0-13: no depression. 14-19: mild depression. 20-28: moderate depression. 29-63: severe depression.
    Assessment of changes in Mental health preoperatively and postoperatively using PROMIS- (Patient-Reported Outcomes Measurement Information System) short form for Depression
    PROMIS-short form (Patient-Reported Outcomes Measurement Information System) for Depression is a set of person-centered measures that evaluates mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. PROMIS items consist of a statement (e.g., "I felt alone") with five response options never, rarely, sometimes, often and always. PROMIS depression score of less than 50 consider normal. A score of 50= mean of genral population sample
    Assessment of changes in Mental health preoperatively and postoperatively using PROMIS-(Patient-Reported Outcomes Measurement Information System) v1 short form for Anxiety
    PROMIS-short form (Patient-Reported Outcomes Measurement Information System) for anxiety is a set of person-centered measures that evaluates mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. PROMIS items consist of a statement (e.g., "I feel fearful") with five response options never, rarely, sometimes, often and always. PROMIS anxiety score of less than 50 consider normal. A score of 50= mean of genral population refrence sample

    Secondary Outcome Measures

    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 questionares A score <4 in the SRS-22-r pain domain (1 = severe pain and 5 = pain free) is considered clinically relevant .
    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 ocial & 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.
    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 questionares: 5=Best mental health outcome score1=warning score
    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 questionares: 5=Best mental health outcome score1=warning score
    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 questionares: 5=Best mental health outcome score1=warning score
    Assessment of changes in Satisfaction with managementscore 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 questionares: 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

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    October 2, 2023
    Sponsor
    Montefiore Medical Center
    Collaborators
    Albert Einstein College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05774002
    Brief Title
    Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
    Acronym
    PASS
    Official Title
    Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    October 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Montefiore Medical Center
    Collaborators
    Albert Einstein College of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the study team investigators have designed a prospective randomized clinical trial (2:1) study for 45 AIS patients (12-19 yrs.). This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome 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
    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 AIS patients (12-19 yrs.). This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Idiopathic Scoliosis (AIS), Mental Health

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    standard of care control groups no psychological intervention
    Arm Type
    No Intervention
    Arm Description
    standard of care control groups no psychological intervention
    Arm Title
    psychological intervention ADAPT
    Arm Type
    Experimental
    Arm Description
    The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Aims to Decrease Anxiety and Pain Treatment (ADAPT)
    Intervention Description
    One pre-operative and 4 post-operative sessions of cognitive behavioral therapy (CBT) treatment in the first two months, beginning 2-3 weeks after surgery, will be completed.
    Primary Outcome Measure Information:
    Title
    Assessment of changes in Mental health preoperatively and postoperatively using Generalized Anxiety Disorder (GAD-7)
    Description
    Assessing Mental health score changes preoperatively and postoperatively using the Generalized Anxiety Disorder (GAD-7) questionnaire. (GAD-7) questionnaire is a seven-item, self-report anxiety questionnaire. The Scores of 0, 1 or 2 are given for experiencing symptoms 'not at all', for 'several days', for 'more than half the days' and for 'nearly every day', respectively. The scores are then totalled and presented from 0 to 21. Scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety, respectively. When screening for an anxiety disorder, a recommended cut-off point for referral for further evaluation is 10 or greater.
    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
    Title
    Assessment of changes in Pain Catastrophizing Scale for Children (PCS-C) preoperatively and postoperatively
    Description
    Pain Catastrophizing Scale for children( 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 done using a Likert-type rating scale, ranging from 0 (not at all) to 4 (extremely). A higher score on this scale would indicate 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
    Title
    Assessment of changes in Mental health preoperatively and post postoperatively using the Patient Health Questionnaire (PHQ)-9.
    Description
    The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders(DSM-IV) criteria as "0" (not at all) to "3" (nearly every day). score of 0-13: no depression. 14-19: mild depression. 20-28: moderate depression. 29-63: severe 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
    Title
    Assessment of changes in Mental health preoperatively and postoperatively using PROMIS- (Patient-Reported Outcomes Measurement Information System) short form for Depression
    Description
    PROMIS-short form (Patient-Reported Outcomes Measurement Information System) for Depression is a set of person-centered measures that evaluates mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. PROMIS items consist of a statement (e.g., "I felt alone") with five response options never, rarely, sometimes, often and always. PROMIS depression score of less than 50 consider normal. A score of 50= mean of genral population sample
    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
    Title
    Assessment of changes in Mental health preoperatively and postoperatively using PROMIS-(Patient-Reported Outcomes Measurement Information System) v1 short form for Anxiety
    Description
    PROMIS-short form (Patient-Reported Outcomes Measurement Information System) for anxiety is a set of person-centered measures that evaluates mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. PROMIS items consist of a statement (e.g., "I feel fearful") with five response options never, rarely, sometimes, often and always. PROMIS anxiety score of less than 50 consider normal. A score of 50= mean of genral population refrence sample
    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
    Secondary Outcome Measure Information:
    Title
    Assessment of changes in pain preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
    Description
    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 questionares A score <4 in the SRS-22-r pain domain (1 = severe pain and 5 = pain free) is considered clinically relevant .
    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
    Title
    sociodemographic factors using Child Opportunity Index (COI)
    Description
    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 ocial & 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
    Title
    Assessment of changes in mental health preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
    Description
    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 questionares: 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
    Title
    Assessment of changes in self image score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
    Description
    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 questionares: 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
    Title
    Assessment of changes in Function score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
    Description
    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 questionares: 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
    Title
    Assessment of changes in Satisfaction with managementscore preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis
    Description
    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 questionares: 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
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of scoliosis prior to age 20 Healthy, non-obese aged 12-19 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leila Mehraban Alvandi, PhD
    Phone
    3474194226
    Email
    lalvandi@montefiore.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eric Fornari, MD
    Phone
    718-920-5532
    Email
    EFORNARI@montefiore.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric D Fornari, MD
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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