Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT05774002
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2023-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000698', 'term': 'Analgesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of changes in Mental health preoperatively and postoperatively using Generalized Anxiety Disorder (GAD-7)', 'timeFrame': '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', '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."}, {'measure': 'Assessment of changes in Pain Catastrophizing Scale for Children (PCS-C) preoperatively and postoperatively', 'timeFrame': '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', '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.'}, {'measure': 'Assessment of changes in Mental health preoperatively and post postoperatively using the Patient Health Questionnaire (PHQ)-9.', 'timeFrame': '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', '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.'}, {'measure': 'Assessment of changes in Mental health preoperatively and postoperatively using PROMIS- (Patient-Reported Outcomes Measurement Information System) short form for Depression', 'timeFrame': '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', '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.\n\nPROMIS items consist of a statement (e.g., "I felt alone") with five response options never, rarely, sometimes, often and always.\n\nPROMIS depression score of less than 50 consider normal. A score of 50= mean of general population sample'}, {'measure': 'Assessment of changes in Mental health preoperatively and postoperatively using PROMIS-(Patient-Reported Outcomes Measurement Information System) v1 short form for Anxiety', 'timeFrame': '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', '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.\n\nPROMIS anxiety score of less than 50 consider normal. A score of 50= mean of general population reference sample'}], 'secondaryOutcomes': [{'measure': 'Assessment of changes in pain preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis', 'timeFrame': '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', '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).\n\nThe 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 .'}, {'measure': 'Sociodemographic factors using Child Opportunity Index (COI)', 'timeFrame': 'preoperatively', 'description': 'The Child Opportunity Index (COI) 2.0 measures neighborhood resources and conditions that matter for children\'s healthy development.\n\nTotal represents the overall index, while Education represents the education metrics, Health represents the health \\& environment metrics, and social \\& economic represents the social \\& economic metrics.\n\nRecord 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.'}, {'measure': 'Assessment of changes in mental health preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis', 'timeFrame': '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', '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).\n\nThe mental health domain has five questionnaires:\n\n5=Best mental health outcome score1=warning score'}, {'measure': 'Assessment of changes in self image score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis', 'timeFrame': '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', '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).\n\nThe self-image domain has five questionnaires:\n\n5=Best mental health outcome score1=warning score'}, {'measure': 'Assessment of changes in Function score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis', 'timeFrame': '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', '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).\n\nThe Function domain has 5 questionnaires:\n\n5=Best mental health outcome score, 1=warning score'}, {'measure': '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', 'timeFrame': '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', '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).\n\nThe Satisfaction with management domain has 2 questionnaires:\n\n5=Best mental health outcome score1=warning score\n\nAre you satisfied with the results of your back management? 5-Very satisfied 4-Satisfied 3-Neither satisfied nor unsatisfied 2-Unsatisfied 1-Very unsatisfied\n\nWould 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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Idiopathic Scoliosis (AIS)', 'Mental Health']}, 'referencesModule': {'references': [{'pmid': '32929399', 'type': 'BACKGROUND', 'citation': 'Marques de Miranda D, da Silva Athanasio B, Sena Oliveira AC, Simoes-E-Silva AC. 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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", 'detailedDescription': "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 (10-19 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of scoliosis prior to age 20\n* Healthy, non-obese aged 10-19 years, with a diagnosis of idiopathic scoliosis, undergoing elective posterior spinal fusion\n\nExclusion Criteria:\n\n* Diagnosis of scoliosis after age 20\n* Permanent cognitive impairment\n* Pregnant or breastfeeding women\n* Use of opioids in the last 6 months\n* Liver or renal diseases and developmental delays'}, 'identificationModule': {'nctId': 'NCT05774002', 'acronym': 'PASS', 'briefTitle': 'Psychological Assessment of Scoliosis Patients Undergoing Surgical Management', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Psychological Assessment of Scoliosis Patients Undergoing Surgical Management (PASS)', 'orgStudyIdInfo': {'id': '2022-14525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard of care control groups no psychological intervention', 'description': 'standard of care control groups no psychological intervention'}, {'type': 'EXPERIMENTAL', 'label': 'psychological intervention ADAPT', 'description': 'The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model.', 'interventionNames': ['Behavioral: Aims to Decrease Anxiety and Pain Treatment (ADAPT)']}], 'interventions': [{'name': 'Aims to Decrease Anxiety and Pain Treatment (ADAPT)', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['psychological intervention ADAPT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leila Mehraban Alvandi, PhD', 'role': 'CONTACT', 'email': 'lalvandi@montefiore.org', 'phone': '718-920-2266'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Leila Mehraban Alvandi, PhD', 'role': 'CONTACT', 'email': 'lalvandi@montefiore.org', 'phone': '347-419-4226'}, {'name': 'Eric Fornari, MD', 'role': 'CONTACT', 'email': 'EFORNARI@montefiore.org', 'phone': '718-920-5532'}], 'overallOfficials': [{'name': 'Eric D Fornari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}