protocolSection identificationModule nctId: NCT06296186, orgStudyIdInfo id: HT94252310669, briefTitle: Massed Prolonged Exposure for PTSD in Substance Use Treatment, acronym: PREVAIL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Veterans Medical Research Foundation, class: OTHER, collaborators name: University of Minnesota, collaborators name: Center for Veterans Research and Education, descriptionModule briefSummary: 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:* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?* 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., conditionsModule conditions: Stress Disorders, Post-Traumatic, conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Prolonged Exposure Therapy, outcomesModule primaryOutcomes measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5), primaryOutcomes measure: Time Line Follow back (TLFB), primaryOutcomes measure: Psychotherapy Completion Rates, secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Brief Psychosocial Functioning Inventory (B-IPF), secondaryOutcomes measure: Client Satisfaction Questionnaire-8 (CSQ-8), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA San Diego Healthcare System, city: San Diego, state: California, zip: 92161, country: United States, contacts name: Sonya Norman, PhD, role: CONTACT, phone: 858-518-8266, email: sonya.norman@va.gov, geoPoint lat: 32.71533, lon: -117.15726, locations facility: VA Tampa Healthcare System, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Brittany Davis, PhD, role: CONTACT, phone: 813-972-2000, email: brittany.davis@va.gov, geoPoint lat: 27.94752, lon: -82.45843, locations facility: VA Atlanta Healthcare System, city: Atlanta, state: Georgia, zip: 30033, country: United States, contacts name: Kristin Lamp, PhD, role: CONTACT, email: kristen.lamp@va.gov, geoPoint lat: 33.749, lon: -84.38798, locations facility: Hines VA Healthcare System, city: Chicago, state: Illinois, zip: 60141, country: United States, contacts name: Jonathan Bayer, PhD, role: CONTACT, email: jonathan.bayer2@va.gov, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False