[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474444":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":42,"centralContacts":51,"locations":61,"responsibleParty":235,"collaborators":238,"id":242,"slug":243,"hasResults":244,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":42,"eligibilityCriteria":248,"healthyVolunteers":244,"sex":249,"minAge":250,"maxAge":42,"enrollmentInfo":251,"targetDuration":42,"studyType":254,"phases":255,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":78,"whyStopped":42,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14,19,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Prolonged Exposure for Primary Care (PE-PC) then continue as early responder","EXPERIMENTAL","PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage (for 8 weeks).",[13],"Behavioral: Prolonged Exposure for Primary Care (PE-PC)",{"label":15,"type":10,"description":16,"interventionNames":17},"Clinician Supported (CS) PTSD Coach App then continue as early responder","During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first). Early responders will be encouraged to continue app use but will discontinue clinician support sessions for the remaining 8 weeks.",[18],"Behavioral: Clinician Supported PTSD Coach App",{"label":20,"type":10,"description":21,"interventionNames":22},"Prolonged Exposure for Primary Care (PE-PC) then full PE","PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to full PE and will have sessions once a week for eight weeks. During these 60-minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.",[13,23],"Behavioral: Full Prolonged Exposure",{"label":25,"type":10,"description":26,"interventionNames":27},"Clinician Supported PTSD Coach App then full PE","During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to full PE will have sessions once a week for eight weeks. During these 60 minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.",[23,18],{"label":29,"type":10,"description":30,"interventionNames":31},"Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC","PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to continue with PE-PC (medium intensity) will continue weekly sessions for 8 weeks.",[13],{"label":33,"type":10,"description":34,"interventionNames":35},"Clinician Supported PTSD Coach App then continued CS PTSD Coach App","During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to continue this treatment will have the frequency reduced to twice monthly.",[18],[37,43,47],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"BEHAVIORAL","Prolonged Exposure for Primary Care (PE-PC)","Treatment follows the standardized PE-PC manual and workbook.PE-PC consists of four weekly 30-minute sessions. In vivo and imaginal exposure are introduced at the first session and reviewed at Sessions 2-4. To conduct in vivo exposure, participants repeatedly and systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage.",[9,29,20],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Full Prolonged Exposure","Treatment will follow the standardized PE manual. Participants will have 60 minute sessions once a week for eight weeks During these sessions, participants will practice in vivo, imaginal, and emotional exposure as well as continue these exposure exercises every day at home.",[25,20],{"type":38,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Clinician Supported PTSD Coach App","This is a brief psychotherapy that uses the PTSD Coach mobile app developed by the study team. The PTSD Coach app incorporates evidence-based assessment, psychoeducation, and cognitive behavioral therapy and self-management strategies that are customizable to the user.",[15,33,25],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":42,"email":56},"Kayla Longuski, MS","CONTACT","734-647-6258","kaylsmit@umich.edu",{"name":58,"role":54,"phone":59,"phoneExt":42,"email":60},"Heather Walters","734-845-3650","heawalte@umich.edu",[62,76,91,103,112,126,139,153,166,179,193,207,221],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":42},"Family Health Care","TERMINATED","Baldwin","Michigan","49304","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-85.85173,43.90112,{"lat":74,"lon":73},{"facility":77,"status":78,"city":79,"state":66,"zip":80,"country":68,"countryCode":69,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Grace Health","RECRUITING","Battle Creek","49037",{"type":71,"coordinates":82},[83,84],-85.17816,42.3173,{"lat":84,"lon":83},[87,89],{"name":88,"role":54,"phone":42,"phoneExt":42,"email":42},"Eric Macleod",{"name":88,"role":90,"phone":42,"phoneExt":42,"email":42},"PRINCIPAL_INVESTIGATOR",{"facility":92,"status":78,"city":93,"state":66,"zip":94,"country":68,"countryCode":69,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Genesee Community Health Center","Flint","48503",{"type":71,"coordinates":96},[97,98],-83.68746,43.01253,{"lat":98,"lon":97},[101],{"name":102,"role":54,"phone":42,"phoneExt":42,"email":42},"Brian Nicholson",{"facility":104,"status":78,"city":93,"state":66,"zip":94,"country":68,"countryCode":69,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Hamilton Community Health Network",{"type":71,"coordinates":106},[97,98],{"lat":98,"lon":97},[109,111],{"name":110,"role":54,"phone":42,"phoneExt":42,"email":42},"Albert Ujkaj",{"name":110,"role":90,"phone":42,"phoneExt":42,"email":42},{"facility":113,"status":78,"city":114,"state":66,"zip":115,"country":68,"countryCode":69,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Cherry Health","Grand Rapids","49503",{"type":71,"coordinates":117},[118,119],-85.66809,42.96336,{"lat":119,"lon":118},[122,124],{"name":123,"role":54,"phone":42,"phoneExt":42,"email":42},"Lindsey Metts",{"name":125,"role":90,"phone":42,"phoneExt":42,"email":42},"Eric Achtyes",{"facility":127,"status":78,"city":128,"state":66,"zip":129,"country":68,"countryCode":69,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"MidMichigan Community Health Services","Houghton Lake","48629",{"type":71,"coordinates":131},[132,133],-84.76475,44.31474,{"lat":133,"lon":132},[136,138],{"name":137,"role":54,"phone":42,"phoneExt":42,"email":42},"Stacey Gedeon",{"name":137,"role":90,"phone":42,"phoneExt":42,"email":42},{"facility":140,"status":78,"city":141,"state":66,"zip":142,"country":68,"countryCode":69,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Upper Great Lakes Family Health Care Center","Menominee","49858",{"type":71,"coordinates":144},[145,146],-87.61427,45.10776,{"lat":146,"lon":145},[149,151],{"name":150,"role":54,"phone":42,"phoneExt":42,"email":42},"Savanna Weber",{"name":152,"role":90,"phone":42,"phoneExt":42,"email":42},"Donald Simila",{"facility":154,"status":78,"city":155,"state":66,"zip":156,"country":68,"countryCode":69,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Family Medical Center of Michigan","Monroe","48162",{"type":71,"coordinates":158},[159,160],-83.39771,41.91643,{"lat":160,"lon":159},[163,165],{"name":164,"role":54,"phone":42,"phoneExt":42,"email":42},"Erica Keith",{"name":164,"role":90,"phone":42,"phoneExt":42,"email":42},{"facility":167,"status":78,"city":168,"state":66,"zip":169,"country":68,"countryCode":69,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Sterling Area Health Center","Sterling","48659",{"type":71,"coordinates":171},[172,173],-84.02277,44.03335,{"lat":173,"lon":172},[176,178],{"name":177,"role":54,"phone":42,"phoneExt":42,"email":42},"Linda LaTulip",{"name":177,"role":90,"phone":42,"phoneExt":42,"email":42},{"facility":180,"status":78,"city":181,"state":182,"zip":183,"country":68,"countryCode":69,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Family Care Health Centers","St Louis","Missouri","63111",{"type":71,"coordinates":185},[186,187],-90.19789,38.62727,{"lat":187,"lon":186},[190,192],{"name":191,"role":54,"phone":42,"phoneExt":42,"email":42},"Jordanna Riebel",{"name":191,"role":90,"phone":42,"phoneExt":42,"email":42},{"facility":194,"status":78,"city":195,"state":196,"zip":197,"country":68,"countryCode":69,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Western North Carolina Community Health Services","Asheville","North Carolina","28801",{"type":71,"coordinates":199},[200,201],-82.55402,35.60095,{"lat":201,"lon":200},[204,206],{"name":205,"role":54,"phone":42,"phoneExt":42,"email":42},"Jessica Parsil",{"name":205,"role":90,"phone":42,"phoneExt":42,"email":42},{"facility":208,"status":78,"city":209,"state":210,"zip":211,"country":68,"countryCode":69,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"CommUnityCare Health Centers","Austin","Texas","78702",{"type":71,"coordinates":213},[214,215],-97.74306,30.26715,{"lat":215,"lon":214},[218,220],{"name":219,"role":54,"phone":42,"phoneExt":42,"email":42},"Heather Gause",{"name":219,"role":90,"phone":42,"phoneExt":42,"email":42},{"facility":222,"status":78,"city":223,"state":224,"zip":225,"country":68,"countryCode":69,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Unity Care NW","Bellingham","Washington","98225",{"type":71,"coordinates":227},[228,229],-122.48822,48.75955,{"lat":229,"lon":228},[232,234],{"name":233,"role":54,"phone":42,"phoneExt":42,"email":42},"Beth Williams",{"name":233,"role":90,"phone":42,"phoneExt":42,"email":42},{"type":90,"investigatorFullName":236,"investigatorTitle":237,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Rebecca Sripada","Associate Professor of Psychiatry",[239],{"name":240,"class":241},"National Institute of Mental Health (NIMH)","NIH","100474444","testing-adaptive-interventions-to-improve-posttraumatic-stress-disorder-treatment-outcomes-in-federally-qualified-health-centers-100474444",false,"NCT05457985","Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers","Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers","Inclusion Criteria:\n\n* Receive care at a participating federally qualified health center (FQHC)\n* Have a Posttraumatic Stress Disorder checklist (PCL-5) score greater or equal (≥) to 33\n* Own a mobile device that can be used for the PTSD Coach App\n* Have had psychotropic medication stability for at least 4 weeks\n\nExclusion Criteria:\n\n* Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)\n* High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form\n* Severe alcohol or substance use disorder (moderate-severe alcohol use disorder on Alcohol Use Disorders Identification Test (AUDIT) (scores ≥ 15) or high risk on National Institute on Drug Abuse Quick Screen (scores ≥ 27))\n* Active psychosis or unmanaged bipolar disorder\n* Unstable housing\n* Current engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).\n* Patients who do not speak English will be excluded for logistical reasons.","ALL","18 Years",{"count":252,"type":253},430,"ESTIMATED","INTERVENTIONAL",[256],"NA","This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.\n\nThe central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.",[259],"PTSD",[261,262,48,263,264],"Prolonged Exposure for Primary Care","Mobile device","PTSD symptoms","Prolonged Exposure\u002FPE","2026-06-29",{"date":267,"type":268},"2026-07-01","ACTUAL",{"date":270,"type":268},"2022-06-23",{"date":272,"type":253},"2027-09-30",{"name":5,"class":6},13]