[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590547":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":46,"responsibleParty":65,"collaborators":68,"id":75,"slug":44,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":44,"enrollmentInfo":84,"targetDuration":44,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":49,"whyStopped":44,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP)","EXPERIMENTAL","Participants randomized to this arm will receive Massed Prolonged Exposure (M-PE) therapy, a gold-standard treatment for PTSD delivered multiple times per week over 2-4 weeks. M-PE will be integrated into the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services, Inc. This arm is designed to evaluate the effectiveness of delivering M-PE concurrently with SUD treatment in improving PTSD symptoms, reducing substance use, and improving patient-centered outcomes.",[13],"Behavioral: Massed Prolonged Exposure Therapy (M-PE)",{"label":15,"type":16,"description":17,"interventionNames":18},"Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group","ACTIVE_COMPARATOR","Participants randomized to this arm will receive the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD), which includes a weekly trauma skills group as part of usual care. This comparator arm allows for evaluation of whether M-PE enhances outcomes beyond those achieved through trauma-informed IOP care.",[19],"Behavioral: Standard outpatient SUD care",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Massed Prolonged Exposure Therapy (M-PE)","Massed Prolonged Exposure (M-PE) is a trauma-focused, evidence-based behavioral intervention for posttraumatic stress disorder (PTSD). It is delivered over a compressed timeline (e.g., 10 sessions over 2-4 weeks) as opposed to weekly sessions over 3-4 months. This format has been shown to accelerate PTSD symptom reduction and reduce treatment dropout. In this study, M-PE will be delivered concurrently with an Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services. Sessions will be led by trained clinicians using a standardized PE protocol, with treatment including imaginal exposure, in vivo exposure, and processing.",[9],[27],"M-PE",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard outpatient SUD care","Patients randomized to usual care will receive standard intensive outpatient SUD treatment.\n\n* Resilience group (weekly)\n* Peer support\n* Individual therapy from a variety of modalities",[15],[33],"Usual Care Condition",[35],{"name":36,"affiliation":37,"role":38},"Sonya Norman Professor Of Clinical, Psychiatry, Ph.D","University of California, San Diego","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D","CONTACT","848-445-0749",null,"denise.hien@smithers.rutgers.edu",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Gateway Community Services","RECRUITING","Jacksonville","Florida","32204","United States",{"type":55,"coordinates":56},"Point",[57,58],-81.65565,30.33218,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":63,"phoneExt":44,"email":64},"Candy Hodgkins CEO - Gateway Comunity Services, Inc., Doctor of Philosophy (Ph.D.)","1-877-389-9966","chodgkins@gwjax.com",{"type":38,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Denise Aimee Hien","Helen E. Chaney Endowed Chair in Alcohol Studies; Distinguished Professor, Graduate School of Applied and Professional Psychology",[69,72,73],{"name":70,"class":71},"National Institute of Mental Health (NIMH)","NIH",{"name":37,"class":6},{"name":74,"class":6},"University of Minnesota","100590547",false,"NCT06968832","Project COMET: Massed Prolonged Exposure for PTSD and SUD","Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program","PROJECT COMET","Inclusion Criteria:\n\n* Age 18+\n* Enrolled in SUD treatment at Gateway Community Services\n* Meet DSM-5 criteria for a SUD (Tobacco Use Disorder alone not sufficient for inclusion)\n* Meet DSM-5 criteria for PTSD\n* Able to give informed consent\n\nExclusion Criteria:\n\n* severe cognitive impairment\n* current suicidal or homicidal intent requiring immediate treatment\n* current unstable psychotic or manic symptoms not attributable to SUD","ALL","18 Years",{"count":85,"type":86},168,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this clinical trial is to learn if Massed Prolonged Exposure Therapy (M-PE) can improve PTSD symptoms and reduce substance use in adults receiving intensive outpatient (IOP) treatment for substance use disorder (SUD). The main questions it aims to answer are:\n\n* Does M-PE reduce PTSD symptoms more effectively than trauma treatment as usual (TAU)?\n* Does M-PE reduce the number of days participants use substances?\n* How do patient-centered outcomes (such as depression, suicidal thoughts, and quality of life) differ between M-PE and trauma TAU?\n* Researchers will compare M-PE to treatment as usual to see if M-PE leads to better mental health and substance use outcomes and lower dropout rates.\n\nParticipants will:\n\n* Attend multiple therapy sessions per week (M-PE) or receive usual care\n* Complete assessments at baseline, during treatment, end-of-treatment, 1-month, 3-month, and 6-month follow-up\n* Share feedback through surveys and interviews about their experience in the program",[92,93,94,95],"Posttraumatic Stress Disorder (PTSD)","Substance Use Disorders (SUD)","Comorbidity","Trauma and Stressor Related Disorders",[92,97,98,99,100,101,102,103,104,105],"Substance Use Disorder (SUD)","PTSD\u002FSUD Comorbidity","Prolonged Exposure Therapy (PE)","Massed Prolonged Exposure (M-PE)","Randomized Clinical Trial (RCT)","Treatment as Usual (TAU)","Integrated PTSD and SUD Treatment","Implementation Science","Trauma-Focused Treatment","2025-10-23",{"date":108,"type":109},"2025-10-27","ACTUAL",{"date":111,"type":109},"2025-09-02",{"date":113,"type":86},"2029-06-30",{"name":5,"class":6},1]