Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-27 @ 5:31 PM
Study NCT ID:
NCT07097792
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concussion Recovery and Support Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data analyst will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Evaluation Inventory, short form', 'timeFrame': '10 weeks', 'description': 'Self-report form regarding acceptability of treatment approach. Minimum 0, maximum 24 (6 items x 4 likert), higher scores indicate higher rating of treatment acceptability.'}], 'secondaryOutcomes': [{'measure': 'HIT6 (Headache Impact Test, 6 item)', 'timeFrame': 'Baseline, 5 weeks, 10 weeks (trajectory over time)', 'description': 'Self-report measure of headache severity, minimum 6 maximum 78, higher scores indicates greater symptoms.'}, {'measure': 'PROMIS fatigue short form', 'timeFrame': 'Baseline/ 5 weeks/ 10 weeks (trajectory over time)', 'description': '7 item self-report scale measuring issues with fatigue. Minimum 7, maximum 35, higher scores indicates more symptoms.'}, {'measure': 'Fear of Concussive Symptoms Questionnaire (FOCSQ)', 'timeFrame': 'Baseline/ 5 weeks/ 10 weeks (trajectory over time)', 'description': 'Self-report measure of fear-avoidance of activities due to concussive symptoms. Minimum 0, maximum 96 (24 items x 4 likert), higher is worse'}, {'measure': 'Post Concussion Symptom Scale (PCSS)', 'timeFrame': 'Baseline/ 5 weeks/ 10 weeks (trajectory over time)', 'description': 'Self-report measure of concussive symptoms, minimum 0, maximum 132 (22 items x 6 likert), higher indicates more symptoms'}, {'measure': 'PROMIS (Patient Reported Outcome Measurement Information System) anxiety', 'timeFrame': 'Baseline/ 5 weeks/ 10 weeks (trajectory over time)', 'description': '8 item scale to measure self-report of anxiety, minimum 8, maximum 40 (5likert x 8), higher indicates more symptoms'}, {'measure': 'PROMIS depression', 'timeFrame': 'Baseline/ 5 weeks/ 10 weeks (trajectory over time)', 'description': '8 item scale to measure self-report of depressive symptoms, minimum 8, maximum 40 (5 likert x 8 items), higher indicates more symptoms'}, {'measure': 'Emotional Approach Coping (EAC)', 'timeFrame': 'Baseline/ 5 weeks/ 10 weeks (trajectory over time)', 'description': 'Self-report survey to measure ability to acknowledge and express emotion, minimum 8, maximum 32 (4 likert x 8), higher indicates more symptoms'}, {'measure': 'Psychological Insight', 'timeFrame': '10 weeks (post-intervention only)', 'description': '6 item self-report scale to measure psychological insight, minimum 0, maximum 24 (4 likert x 6), higher indicates greater insight'}, {'measure': 'PROMIS sleep disturbance SF', 'timeFrame': 'Baseline/ 4 weeks/ 8 weeks (trajectory over time)', 'description': 'Self-report measure of sleep disturbance, minimum 8, maximum 40 (5 likert x 8), higher indicates more symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental health', 'therapy', 'emotional awareness and expression therapy'], 'conditions': ['Brain Concussion', 'Mild Traumatic Brain Injury', 'Headache']}, 'referencesModule': {'references': [{'pmid': '31123837', 'type': 'BACKGROUND', 'citation': 'Lumley MA, Schubiner H. Emotional Awareness and Expression Therapy for Chronic Pain: Rationale, Principles and Techniques, Evidence, and Critical Review. Curr Rheumatol Rep. 2019 May 23;21(7):30. doi: 10.1007/s11926-019-0829-6.'}]}, 'descriptionModule': {'briefSummary': 'Pilot randomized controlled trial (RCT) comparing a novel intervention Concussion Recovery and Support Program (CRISP) for adolescents and young adults (AYA) 18-29 yo with concussion/ mild TBI.', 'detailedDescription': 'The authors are conducting a pilot study to examine the feasibility, acceptability and pilot efficacy of a novel intervention called CRISP for young adults with persistent concussion/ mTBI. CRISP is an adaptation of an evidence-based treatment for chronic pain called Emotional Awareness and Expression Therapy (EAET). EAET targets underlying emotional responses that appear to drive persistent symptoms, and has been found effective for treating headache and other types of pain in randomized controlled trials with moderately strong effect sizes (0.4-0.5).\n\nIndividuals who participate in this study will complete 6 sessions of CRISP with a trained therapist over zoom (each 60 minutes) and will also fill out surveys at multiple time points (baseline, 5 weeks, 10 weeks).\n\nAim 1: Evaluate feasibility and acceptability of CRISP with a pilot study of n=40 individuals with concussion ages 18-30 years who are struggling with headache. Hypothesis: CRISP will be a feasible and acceptable approach to treating AYA with concussion.\n\nAim 2: Collect pilot data regarding efficacy of CRISP for reducing concussion symptoms and improving function (particularly regarding headache). Hypothesis: Pilot data may show benefit from this approach for improving recovery, though we do not expect significance given the sample size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with a concussion and at least 2 weeks from injury but less than two years.\n* New or worsening headache since concussion\n* Had at least one day with headache last week of moderate severity or two days with headache of any severity\n\nExclusion Criteria:\n\n* Non-English speaking\n* Chronic medical illness/ medical complexity\n* Housing instability\n* Acute mental health issues such as active suicidality, psychiatric hospitalization within the past 6 months, ER visit for suicidality in the past 6 months or experiencing psychosis or delusions'}, 'identificationModule': {'nctId': 'NCT07097792', 'acronym': 'CRISP', 'briefTitle': 'Concussion Recovery and Support Program', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Pilot Study of Concussion Recovery and Support Program (CRISP)', 'orgStudyIdInfo': {'id': '00005446'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRISP', 'description': 'CRISP is an adaptation of an approach called EAET that was originally designed to treat individuals with chronic pain. The goal of this approach is to target underlying emotional reactions that may be causing symptoms to persist. This intervention will be delivered in 6 sessions over 10 weeks.', 'interventionNames': ['Behavioral: CRISP (Concussion Recovery and Support Program)']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual (TAU)', 'description': 'Treatment as usual.'}], 'interventions': [{'name': 'CRISP (Concussion Recovery and Support Program)', 'type': 'BEHAVIORAL', 'description': 'Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.', 'armGroupLabels': ['CRISP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara P Chrisman, MD MPH', 'role': 'CONTACT', 'email': 'crisp@seattlechildrens.org', 'phone': '206-884-1490'}], 'facility': "Seattle Children's Research Institute", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bethany Pester, PhD', 'role': 'CONTACT', 'email': 'crisp@seattlechildrens.org', 'phone': '206-884-1490'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Sara PD Chrisman, MD MPH', 'role': 'CONTACT', 'email': 'crisp@seattlechildrens.org', 'phone': '206-884-1490'}, {'name': 'Allina Flaat, MPH', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Would consider sharing in a collaborative fashion given pilot nature of study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sara PD Chrisman, MD MPH', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}