[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07463027":3,"trial-entities:NCT07463027":91,"trial-summary:NCT07463027":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":46,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":74,"locations":77,"central_contacts":87,"overall_officials":88,"references":89,"see_also_links":90},"NCT07463027","PRO00056712","Veteran's Interdisciplinary Care for Traumatic Brain Injury and Co-Occurring Disorders Rehabilitation Trial","Veteran's Interdisciplinary Care for Traumatic Brain Injury & Co-Occurring Disorders Rehabilitation Trial - A Pragmatic, Randomized, Controlled Clinical Trial","ENROLLING_BY_INVITATION","2029-05","2026-03","2026-04-02","2026-03-26","Medical College of Wisconsin","OTHER",null,"The goal of this clinical trial is to learn if the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) can reduce long-lasting symptoms of traumatic brain injury (TBI) and co-occurring disorders in veterans and first responders. The main questions it aims to answer are:\n\n* Does a 3-week IORP reduce symptoms of long-lasting TBI and co-occurring disorders in military veterans and first responders?\n* Does the 3-week IORP improve life quality and function in military veterans and first responders?\n\nResearchers will compare the Control group to the Invention group to see if a 3-week of IORP reduced symptoms of TBI and co-occurring disorders in military veterans and first responders.\n\nParticipants will complete the following activities. The items with an asterisk(\\*) are not required or available at all sites.\n\n* Answer online survey questions about their TBI symptoms, life satisfaction, and life activities\n* Complete two blood draws\\*\n* Complete two magnetic resonance imaging (MRI) brain scans\\*",[18],"Traumatic Brain Injury and Co-occurring Disorders",[20,21,22,23,24,25],"Traumatic Brain Injury","Veterans","First Responders","TBI","Interdisciplinary Outpatient Rehabilitation Program","IORP","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},416,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","3-week interdisciplinary outpatient rehab program (IORP)","Interdisciplinary outpatient rehabilitation program (IORP) for military veterans and first responders experiencing chronic effects of traumatic brain injury (TBI) and co-occurring disorders (e.g., posttraumatic stress disorder, depression, substance use).",[39,40],"Control Waiting Period Arm","Interdisciplinary Outpatient Rehabilitation Program Intervention Arm",[42],{"measure":43,"description":44,"timeFrame":45},"Mean change in Neurobehavioral Symptom Inventory (NSI)","The NSI is a 22-item self-report questionnaire used to assess neurobehavioral symptoms, particularly those following a TBI","Baseline enrollment to 3-month follow-up (post IORP)",[47,51,54],{"measure":48,"description":49,"timeFrame":50},"Mean change in Satisfaction with Life Scale (SWLS)","The SWLS is a brief questionnaire used to assess an individual's general satisfaction with their life. It is a self-report scale where participants respond to five statements using a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree)","Baseline enrollment to 3 months post-IORP and 6 months post-IORP",{"measure":52,"description":53,"timeFrame":50},"Life Satisfaction Questionnaire (LISAT-11)","LISAT-11 is a brief questionnaire used to assess life satisfaction in life domains such as: vocational, financial and leisure situations, contact with friends, sexual life, self-care management, family life, partner relationship, physical health, and psychological health.",{"measure":55,"description":56,"timeFrame":50},"Participation Assessment with Recombined Tools-Objective (PART-O)","The PART-O measures an individual's engagement in everyday life across 17 items spanning three domains: Productivity, Social Relations, and Out and About. The PART-O was developed to examine long-term outcomes and can also be used to evaluate the effectiveness of rehabilitative interventions to improve social\u002Fsocietal functioning.","ALL","18 Years","65 Years",false,{"inclusion":62,"exclusion":67,"raw_text":73},[63,64,65,66],"Meets general eligibility requirements for site specific 3-week IORP","Capable of providing informed consent for IORP and study participation","English speaking","18 to 65 years old",[68,69,70,71,72],"History of TBI of any severity in the past 6 months","Active substance use disorder that precludes study participation","Neurologic, psychiatric, or other medical condition that would prohibit full study participation","Active-duty military service member","Any other circumstance that, in the opinion of the investigator, would undermine the integrity or success of the project","Inclusion Criteria:\n\n* Meets general eligibility requirements for site specific 3-week IORP\n* Capable of providing informed consent for IORP and study participation\n* English speaking\n* 18 to 65 years old\n\nExclusion Criteria:\n\n* History of TBI of any severity in the past 6 months\n* Active substance use disorder that precludes study participation\n* Neurologic, psychiatric, or other medical condition that would prohibit full study participation\n* Active-duty military service member\n* Any other circumstance that, in the opinion of the investigator, would undermine the integrity or success of the project",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"BRAVE Program","Milwaukee","Wisconsin","53226","United States",{"lat":85,"lon":86},43.0389,-87.90647,[],[],[],[],{"nct_id":4,"conditions":92,"biomarkers":95},[93,94],"Co-occurring Disorders","Traumatic Encephalopathy",[],{"nct_id":4,"found":60,"summary":15,"prompt_version":15}]