Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT05998369
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2023-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowered Relief for Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Child Pain Self-Efficacy Scale (PSES-C)', 'timeFrame': 'Pre class, 4 weeks, 8 weeks, and 12 weeks post class', 'description': 'The Child Pain Self- Efficacy Scale assesses the participants self-efficacy with regard to normal functioning when in pain based on a ranked scale (score 1 = "very sure" to 5 = "very unsure") with higher scores indicating enhanced uncertainty.'}, {'measure': 'PROMIS Anxiety', 'timeFrame': 'Pre class, 4 weeks, 8 weeks, and 12 weeks post class', 'description': 'The PROMIS anxiety study assesses fear, fear, misery, hyperarousal, and somatic symptoms related to arousal within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater experience to anxiety.'}], 'primaryOutcomes': [{'measure': 'Treatment Expectancy Credibility (TEC-C)', 'timeFrame': 'Immediately post class', 'description': 'The TEC-C assess treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = "not at all" to 10 = "very much") with a higher score indicating high expectations.'}, {'measure': 'Program Feedback Scale', 'timeFrame': 'Immediately post class', 'description': 'The Program Feedback Scale assesses participants agreement to seven statements indicating their perceived acceptability and feasibility based on a scale (score 0 = "really disagree" to 4 = "really agree") with a higher score indicating positive feedback and two open ended questions.'}], 'secondaryOutcomes': [{'measure': 'PROMIS Pain Interference', 'timeFrame': 'Pre class, 4 weeks, 8 weeks, and 12 weeks post class', 'description': 'The PROMIS Pain Interference form assesses to what level pain hinders their engagement in several activities using a ranked scale (score 0 = "never" to 4 = "almost always") with a higher score indicating great pain interference.'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': '4 weeks, 8 weeks, and 12 weeks post class', 'description': 'The Pain Global Impression of Change survey asks participants to rank how their overall pain has changed since the start of study using a ranked scale (score 0 = "very much improved" to 6 = "very much worse") with higher scores indicating greater severity to their pain.'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Pre class, 4 weeks, 8 weeks, and 12 weeks post class', 'description': 'The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (score 0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Musculoskeletal Pain', 'Fibromyalgia', 'Neuropathic Pain', 'Complex Regional Pain Syndromes', 'Abdominal Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single-session pain management class for youth focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class. Feasibility and acceptability of ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class.', 'detailedDescription': "The current proposed, single-arm, uncontrolled pilot study will determine a) feasibility of ER-Y in youth with chronic pain, b) patients' perceptions and satisfaction of the ER-Y class and c) preliminary efficacy to inform the design of a subsequent randomized controlled trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 10 years old to 18 years\n* Diagnosis of Chronic Pain\n* English speaking\n\nExclusion Criteria:\n\n* Significant psychosocial complexity (e.g., severe depression/ anxiety, unable to tolerate a group setting)\n* non-English Speaking'}, 'identificationModule': {'nctId': 'NCT05998369', 'acronym': 'ER-Y', 'briefTitle': 'Empowered Relief for Youth', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain', 'orgStudyIdInfo': {'id': '68451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empowered Relief for Youth', 'description': 'Empowered Relief for Youth is a single-session pain management class focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class.', 'interventionNames': ['Behavioral: Empowered Relief for Youth']}], 'interventions': [{'name': 'Empowered Relief for Youth', 'type': 'BEHAVIORAL', 'description': 'The Empowered Relief for Youth is a 90-minute class that provides pain science education, as well as cognitive, emotional, and physiologic self-regulation skills for youth with chronic pain. Youth will also develop a personalized plan to use the acquired skills daily. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.', 'armGroupLabels': ['Empowered Relief for Youth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Laura Simons, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Laura E Simons', 'investigatorAffiliation': 'Stanford University'}}}}