[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579100":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":86,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":25,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":25,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)","EXPERIMENTAL","The ACT intervention group will receive Acceptance and Commitment Therapy (ACT) + usual care rehabilitation exercises and behavioral management during four weekly in person sessions along with daily at-home activities during the 4 week treatment period. The four ACT sessions will last 60 minutes each and will include: 1) values clarification and goal setting; 2) skills training in psychological flexibility including emotional acceptance, cognitive defusion, and present moment awareness; and 3) practice engaging these skills to overcome mental obstacles to values-driven goal attainment.",[13,14],"Behavioral: Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)","Behavioral: Usual Care Rehabilitation",{"label":16,"type":17,"description":18,"interventionNames":19},"Usual Care Rehabilitation (CONTROL)","ACTIVE_COMPARATOR","The CONTROL group will receive standard of care evaluations and treatments involving a holistic multidisciplinary approach, but will exclude any ACT components. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular, rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions such as instruction regarding stress reduction. The usual care intervention will be coordinated by a primary treating clinician and additional specialty care providers as indicated by the participant's evaluation, individualized patient goals, and concomitant treatments.",[14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Participants will receive the ACT treatment. It is comprised of three processes: Open Up, Be Present, and Do What Matters. Each of these is further sub-divided, for a total of six core processes. These processes include, but are not limited to, present moment awareness, de-fusion, and committed action. This group will also receive targeted vestibular therapy and standardized behavioral management strategies (physical activity, sleep, hydration, and nutrition prescription). Participants will also receive usual care at the discretion of each site's treating providers.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care Rehabilitation","Participants will receive usual care treatment at the discretion of each site's treating providers, excluding any components associated with ACT. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions.",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Anthony Kontos, PhD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","814-615-2163","akontos@pitt.edu",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Courtney Perry, MS","412-904-1298","cap236@pitt.edu",[44,65],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University of Pittsburgh Concussion Research Laboratory","RECRUITING","Pittsburgh","Pennsylvania","15213-4512","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-79.99589,40.44062,{"lat":56,"lon":55},[59,62],{"name":60,"role":36,"phone":41,"phoneExt":25,"email":61},"Cyndi Holland, MPH","clh197@pitt.edu",{"name":63,"role":64,"phone":25,"phoneExt":25,"email":25},"Eric Meyer, PhD","SUB_INVESTIGATOR",{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":50,"countryCode":51,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Intrepid Spirit Center, Carl R. Darnall Army Medical Center","NOT_YET_RECRUITING","Fort Hood","Texas","76544",{"type":53,"coordinates":72},[73,74],-97.70913,31.25483,{"lat":74,"lon":73},[77,81,84],{"name":78,"role":36,"phone":79,"phoneExt":25,"email":80},"Scot Engel, PsyD","254-287-7281","scot.d.engel.civ@health.mil",{"name":82,"role":36,"phone":25,"phoneExt":25,"email":83},"Stacey Young-McCaughan, PhD","youngs1@uthscsa.edu",{"name":85,"role":64,"phone":25,"phoneExt":25,"email":25},"Alan Peterson, PhD",{"type":33,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Anthony P. Kontos, Ph.D.","Research Director",[90],{"name":91,"class":92},"United States Department of Defense","FED","100579100","acceptance-and-commitment-therapy-integrated-vestibular-rehabilitation-active-rct-100579100",false,"NCT06819904","Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT","Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial","Inclusion Criteria:\n\n* 18-49 years of age\n* Normal\u002Fcorrected vision\n* Diagnosed with mTBI per military clinical practice guidelines (CPGs) that occurred over 8 days prior to consent as determined by a multi-domain assessment performed by a licensed healthcare professional.\n* mTBI-related symptoms and\u002For impairments in at least one or more areas, including vestibular (dizziness, imbalance), psychological health (anxiety, depression, stress), cognitive (memory problems), headache\u002Fmigraine, ocular, or sleep. as determined by self-report.\n\nExclusion Criteria:\n\n* History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report.\n* History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report.\n* Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report.\n* Previous moderate to severe TBI as determined by self-report.\n* \\\u003C 8 days following current mTBI as determined by self-report.\n* Currently pregnant as determined by self-report.","ALL","18 Years","49 Years",{"count":104,"type":105},250,"ESTIMATED","INTERVENTIONAL",[108],"NA","The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) with usual care rehabilitation (CONTROL) in 250 individuals with mTBI-related symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.",[111,112,113],"Concussion, Mild","Mild Traumatic Brain Injury (mTBI)","Psychological Health",[115,116,117,118],"concussion","mTBI","psychological health","treatment","2026-06-25",{"date":121,"type":122},"2026-06-30","ACTUAL",{"date":124,"type":122},"2025-02-27",{"date":126,"type":105},"2027-08",{"name":5,"class":6},2]