[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06296186":3,"trial-entities:NCT06296186":174,"trial-summary:NCT06296186":179},{"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":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":49,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":77,"locations":80,"central_contacts":159,"overall_officials":167,"references":172,"see_also_links":173},"NCT06296186","HT94252310669","Massed Prolonged Exposure for PTSD in Substance Use Treatment","Clinical Effectiveness and Implementation of Massed Prolonged Exposure for PTSD Among Veterans in Intensive Outpatient Substance Use Treatment (MPE)","RECRUITING","2028-08","2026-08","2026-08-27","2024-09-01","Veterans Medical Research Foundation","OTHER",true,"The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:\n\n* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?\n* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week.","Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) often co-occur. PTSD+SUD comorbidity is associated with more severe PTSD, worse treatment outcomes for substance use, greater suicide risk and worse functioning than having one of these disorders. First-line treatments for PTSD, particularly Prolonged Exposure Therapy (PE), are effective in treating PTSD among those with a SUD, and delivering these treatments concurrent to SUD programming is recommended by the VA\u002FDoD Clinical Practice Guidelines. While PE is one of the most effective treatment options for PTSD among those with PTSD+SUD, effects are smaller and dropout is higher than among people with PTSD without a SUD. A promising way to enhance outcomes is to offer PE in a massed format (M-PE; i.e., multiple sessions per week instead of once weekly). M-PE has been shown to be effective in improving PTSD symptoms and substantially reducing dropout in military and Veteran populations. Preliminary findings suggest M-PE delivered concurrent to intensive SUD programming is a promising strategy that warrants further study. Evaluating the effectiveness of M- PE delivery in of SUD intensive outpatient programming (IOP) in improving PTSD and other mental health outcomes and reducing dropout as compared to weekly PE delivery (W-PE) is the necessary next step in this critical research.\n\nThe primary goal of this project is to determine if a promising way to treat PTSD among those with SUD, M-PE, will help Veterans with their PTSD symptoms and lead to better treatment completion rates more than PE delivered weekly and if the massed format will reduce substance use comparably to weekly PE among those in intensive SUD treatment. The study will also evaluate if M-PE helps Veterans function better and feel less depressed. M-PE is a one-on-one talk therapy that is delivered over twelve sessions several times a week. The therapy is brief because of the massed format so that it can be delivered at times when lengthy interventions may not be realistic, such as military mental health clinics on bases where military personnel may be getting ready to redeploy. The research team's preliminary work with Veterans in intensive SUD treatment showed M-PE to lead to improvements in PTSD and depression symptoms with no dropout, making this larger evaluation of M-PE compared to PE delivered in the traditional longer (weekly) format a critical next step. The study will accomplish this by randomly assigning participants who are in intensive SUD treatment to receive either M-PE or W-PE. The study will have 200 Veterans who served post 9\u002F11 go through this study and the entire study is expected to take four years to complete. The study will run the study across four VAs (San Diego, Tampa, Chicago, and Atlanta).",[19,20],"Stress Disorders, Post-Traumatic","Substance Use Disorders",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},200,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Prolonged Exposure Therapy","Exposure therapy for PTSD",[35,36],"Massed PE","Weekly PE",[38,42,45],{"measure":39,"description":40,"timeFrame":41},"Clinician Administered PTSD Scale for DSM-5 (CAPS-5)","Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity","At 4-, 16-, 28-, and 40-weeks post-first therapy session",{"measure":43,"description":44,"timeFrame":41},"Time Line Follow back (TLFB)","Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use",{"measure":46,"description":47,"timeFrame":48},"Psychotherapy Completion Rates","Percent of participants completing all sessions of psychotherapy, range is 0-100%, higher number means greater percent completed therapy","16 weeks",[50,53,56],{"measure":51,"description":52,"timeFrame":41},"Patient Health Questionnaire-9 (PHQ-9)","Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity",{"measure":54,"description":55,"timeFrame":41},"Brief Psychosocial Functioning Inventory (B-IPF)","Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment",{"measure":57,"description":58,"timeFrame":48},"Client Satisfaction Questionnaire-8 (CSQ-8)","Measures satisfaction with treatment, scores range from 8 to 32. higher scores indicate greater satisfaction with treatment","ALL","18 Years",null,false,{"inclusion":64,"exclusion":72,"raw_text":76},[65,66,67,68,69,70,71],"Veterans","age 18+","who have served since September 2001","who are enrolled in a SUD IOP at a participating VA","meet DSM-5 criteria for PTSD","report substance use at least 20 of the last 90 days","are able to give informed consent.",[73,74,75],"severe cognitive impairment","current suicidal or homicidal intent requiring immediate treatment","current unstable psychotic or manic symptoms not attributable to SUD","Inclusion Criteria:\n\n* Veterans\n* age 18+\n* who have served since September 2001\n* who are enrolled in a SUD IOP at a participating VA\n* meet DSM-5 criteria for a current SUD (Tobacco Use Disorder alone not sufficient for inclusion)\n* meet DSM-5 criteria for PTSD\n* report substance use at least 20 of the last 90 days\n* are 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",[78,79],"ADULT","OLDER_ADULT",[81,96,109,121,133,146],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":93},"VA San Diego Healthcare System","San Diego","California","92161","United States",[88],{"name":89,"role":90,"phone":91,"email":92},"Sonya Norman, PhD","CONTACT","8585188266","sonya.norman@va.gov",{"lat":94,"lon":95},32.71571,-117.16472,{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":86,"contacts":101,"geoPoint":106},"VA Tampa Healthcare System","Tampa","Florida","33612",[102],{"name":103,"role":90,"phone":104,"email":105},"Brittany Davis, PhD","813-972-2000","brittany.davis@va.gov",{"lat":107,"lon":108},27.94752,-82.45843,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":86,"contacts":114,"geoPoint":118},"VA Atlanta Healthcare System","Atlanta","Georgia","30033",[115],{"name":116,"role":90,"email":117},"Kristin Lamp, PhD","kristen.lamp@va.gov",{"lat":119,"lon":120},33.749,-84.38798,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":86,"contacts":126,"geoPoint":130},"Hines VA Healthcare System","Chicago","Illinois","60141",[127],{"name":128,"role":90,"email":129},"Jonathan Bayer, PhD","jonathan.bayer2@va.gov",{"lat":131,"lon":132},41.85003,-87.65005,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":86,"contacts":138,"geoPoint":143},"New Orleans VA Medical Center","New Orleans","Louisiana","70119",[139],{"name":140,"role":90,"phoneExt":141,"email":142},"Chelsea Ennis","(800) 935-8387","chelsea.ennis@va.gov",{"lat":144,"lon":145},29.95465,-90.07507,{"facility":147,"status":8,"city":148,"state":149,"zip":150,"country":86,"contacts":151,"geoPoint":156},"Cleveland VA","Cleveland","Ohio","44106",[152],{"name":153,"role":90,"phone":154,"email":155},"Vanessa Facemire, PhD","216-791-3800","vanessa.facemire@va.gov",{"lat":157,"lon":158},41.4995,-81.69541,[160,163],{"name":89,"role":90,"phone":161,"email":162},"858-518-8266","snorman@ucsd.edu",{"name":164,"role":90,"phone":165,"email":166},"Kaitlyn Panza, PhD","858-552-8585","kaitlyn.panza@va.gov",[168],{"name":169,"affiliation":170,"role":171},"Shannon Kehle-Forbes, PhD","University of Minnesota","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":175,"biomarkers":178},[176,177],"Post-Traumatic Stress Disorder","Substance use disorder",[],{"nct_id":4,"found":15,"summary":180,"prompt_version":190},{"design":181,"status":182,"heading":183,"summary":184,"follow_up":185,"word_count":186,"commitments":187,"compensation":188,"drugs_mentioned":189},"This interventional study is comparing two ways of delivering Prolonged Exposure Therapy: multiple sessions per week versus once per week. It aims to enroll 200 participants.","completed","Prolonged Exposure Therapy for PTSD and Substance Use Disorder","This study is looking at how well a type of talk therapy called Prolonged Exposure Therapy (PE) works for veterans who have both Post-Traumatic Stress Disorder (PTSD) and a Substance Use Disorder (SUD). Researchers want to see if having PE sessions multiple times a week (massed format) is as helpful as having them once a week. The study will measure changes in PTSD symptoms using a tool called CAPS-5, and track substance use over time. You might be able to join if you are a veteran aged 18 or older, served after September 2001, are in an intensive outpatient program for SUD at a participating VA, and have both PTSD and SUD. The study aims to enroll 200 participants.","Participants will be followed for 40 weeks after their first therapy session to measure PTSD symptoms and substance use.",119,"You would participate in Prolonged Exposure Therapy sessions, either weekly or multiple times per week. Your PTSD symptoms and substance use will be measured at 4, 16, 28, and 40 weeks after your first therapy session.","Not stated in the trial record.",[32],"v2"]