[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376393":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":50,"locations":61,"responsibleParty":119,"collaborators":10,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":10,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":129,"minAge":130,"maxAge":10,"enrollmentInfo":131,"targetDuration":10,"studyType":134,"phases":10,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"U.S. Army Medical Research and Development Command","FED",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"Individuals randomized to Cohort 1 will be assigned to the CAPS-5 and will complete between two and seven research visits. Participants will be administered the CAPS-5 during visit 2, and then will be randomized a second time into groups 1-A and 1-B. Group 1-A will end participation after visit 2. Group 1-B will complete visits 3-7 and will be administered the CAPS-5 at each of these visits along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.",[13],"Diagnostic Test: CAPS-5",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Individuals randomized to Cohort 2 will be assigned to the PSSI-5 and will complete between two and seven research visits. Participants will be administered the PSSI-5 during visit 2, and then will be randomized a second time into groups 2-A and 2-B. Group 2-A will end participation after visit 2. Group 2-B will complete visits 3-7 and will be administered the PSSI-5 at each of these visits along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.",[18],"Diagnostic Test: PSSI-5",{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 3","Individuals randomized to Cohort 3 will have three office visits and will complete the CAPS-5 and the PSSI-5 in a counter-balanced order during visits 2 and 3, along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.",[13,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort 4","Individuals randomized to Cohort 4 will have three office visits and will complete the CAPS-IV and the CAPS-5 in a counter-balanced order during visits 2 and 3, along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.",[13,27],"Diagnostic Test: CAPS-IV",[29,34,38],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"DIAGNOSTIC_TEST","CAPS-5","Clinician Administered PTSD Scale for DMS-5",[9,20,24],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"PSSI-5","PTSD Symptom Scale Interview for DSM-5",[15,20],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"CAPS-IV","Clinician Administered PTSD Scale for DSM-IV",[24],[43,47],{"name":44,"affiliation":45,"role":46},"Kathleen M Chard, PhD","Cincinnati VA Medical Center, University of Cincinnati","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":49,"role":46},"Brian Marx, PhD","National Center for PTSD at VA Boston Healthcare System",[51,57],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Savannah Noppert","CONTACT","513-861-3100","313262","savannah.noppert@va.gov",{"name":58,"role":53,"phone":54,"phoneExt":59,"email":60},"Derrell Anderson, MS","313309","derrell.anderson@va.gov",[62,85,102],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Tripler Army Medical Center","RECRUITING","Honolulu","Hawaii","96859","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-157.85833,21.30694,{"lat":74,"lon":73},[77,81],{"name":78,"role":53,"phone":79,"phoneExt":10,"email":80},"Catherine Uyehara, PhD","808-433-7163","catherine.yamauchi2.civ@health.mil",{"name":82,"role":53,"phone":83,"phoneExt":10,"email":84},"Monique Weisman, LSW","808-433-5067","monique.s.weisman.ctr@health.mil",{"facility":86,"status":64,"city":87,"state":88,"zip":89,"country":68,"countryCode":69,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Cincinnati VA Medical Center - Trauma Recovery Center","Fort Thomas","Kentucky","41075",{"type":71,"coordinates":91},[92,93],-84.44716,39.07506,{"lat":93,"lon":92},[96,99,101],{"name":97,"role":53,"phone":54,"phoneExt":55,"email":98},"Savannah Noppert, MS","savnnah.noppert@va.gov",{"name":100,"role":53,"phone":54,"phoneExt":59,"email":60},"Derrell Anderson",{"name":44,"role":46,"phone":10,"phoneExt":10,"email":10},{"facility":103,"status":64,"city":104,"state":105,"zip":106,"country":68,"countryCode":69,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Walter Reed National Military Medical Center","Bethesda","Maryland","20814",{"type":71,"coordinates":108},[109,110],-77.10026,38.98067,{"lat":110,"lon":109},[113,117],{"name":114,"role":53,"phone":115,"phoneExt":10,"email":116},"Nathalie Jimenez","202-377-9687","nathalie.t.jimenez.ctr@health.mil",{"name":118,"role":46,"phone":10,"phoneExt":10,"email":10},"Treven C Pickett, PsyD",{"type":120,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100376393","an-evaluation-of-two-ptsd-assessments-in-an-active-duty-and-military-veteran-sample-100376393",false,"NCT04180930","An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample","Psychometric Evaluation of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) in an Active Duty and Military Veteran Sample","Inclusion Criteria:\n\n* Male or female active duty personnel or military veterans, 18 years of age or older\n* Competent to give informed consent\n* Have experienced any Criterion A qualifying traumatic event as defined by the Life Events Checklist for DSM-5 (LEC-5)\n* Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)\n\nExclusion Criteria:\n\n* Current suicidal or homicidal ideation with a plan, and substance use disorder requiring detoxification currently or in the past month as assessed using the SCID and Suicidal Ideation\u002FHomicidal Ideation screening tool (SI\u002FHI screen)\n* Assessment using CAPS or PSSI in the previous 1 year\n* Currently receiving psychotherapy or counseling for PTSD\n* Moderate to sever cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)\n* Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month",true,"ALL","18 Years",{"count":132,"type":133},950,"ESTIMATED","OBSERVATIONAL","Given the high prevalence of post-traumatic stress disorder (PTSD) in veterans and active duty military, the focus of this research study is to test the reliability of two new PTSD assessments, the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) and compare the results between the two new assessments and the previous \"gold standard\", the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV). Biomarkers believed to be related to PTSD (e.g., biofluid biomarkers, cognitive and physiological markers, and neural activity as measured by EEG) will be collected to inform targeted interventions in specific groups of patients and other large-scale biomarker discovery efforts in the field. Participants will be 950 male and female active duty military and veterans ages 18 or older who have been exposed to at least one traumatic event.",[137],"Stress Disorders, Post-Traumatic",[139,140,141,142,143],"Assessment","Post-Traumatic Stress Disorder","PTSD","Veterans","Military","2025-01-22",{"date":146,"type":147},"2025-01-23","ACTUAL",{"date":149,"type":147},"2019-04-15",{"date":151,"type":133},"2025-06-30",{"name":5,"class":6},3]