[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653113":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":56,"studyPopulation":56,"armGroups":63,"interventions":76,"overallOfficials":56,"centralContacts":86,"locations":96,"responsibleParty":115,"collaborators":119,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":56,"enrollmentInfo":132,"targetDuration":56,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":143,"whyStopped":56,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Potomac Health Foundations","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"PTSD symptom reduction","PTSD symptom reduction pre\u002Fpost intervention by treatment arm as measured by he PTSD Checklist for DSM-5 (PCL-5) and the Clinician-Administered PTSD Scale for DSM-5 (CAPS). The PCL-5 is a 20-item self-report questionnaire that yields a total symptom scores ranging from 0-80 with higher scores indicating greater symptomology. The CAPS is a 30-item structured interview that yields a diagnosis of PTSD, a total PTSD symptom severity score, and a severity score for each symptom cluster.","Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.",[14,17,20,23,26,29,32,35,38,41,45,49,53],{"measure":15,"description":16,"timeFrame":12},"Days of Substance Use","Timeline Follow-back (TLFB) will assess opioid and other substance use in the 30 days prior to residential treatment admission and at all follow-ups. Participants will be shown a reference sheet that describes standard drinks (see attached) to help them more easily recall how many standard drinks they have consumed in the past month.",{"measure":18,"description":19,"timeFrame":12},"Substance Use Exposure","Kreek-McHugh-Schuluger-Kellogg scale (KMSK) will assess participants' lifetime and past 30-day exposure to specific substances. The KMSK items assessing past 30-day usage will be administered during all follow up appointments.",{"measure":21,"description":22,"timeFrame":12},"Anxiety Symptoms","General Anxiety Disorder (GAD-7) will assess symptoms of anxiety.",{"measure":24,"description":25,"timeFrame":12},"Depressive Symptoms","Patient Health Questionnaire-9 (PHQ-9) will assess depressive symptoms.",{"measure":27,"description":28,"timeFrame":12},"Recovery Capital","Brief Assessment of Recovery Capital (BARC-10) will assess participant-reported areas of recovery capital.\n\nMultidimensional Inventory of Recovery Capital (MIRC): designed to assess the resources a person uses to resolve alcohol or drug problems.",{"measure":30,"description":31,"timeFrame":12},"Treatment Outcomes","Treatment Utilization Self-Report Form: an investigator-created form will collect data on ongoing engagement in SUD treatment, mental health, and hospital services.\n\nMedication Continuity assessment (see participant information document): will track adherence with medications prescribed during treatment, including addiction-related and other psychotropic medications.",{"measure":33,"description":34,"timeFrame":12},"Moral Injury","Moral Injury and Distress Scale (MIDS) will assess exposure to potentially morally injurious events and the possible impacts of moral injury.",{"measure":36,"description":37,"timeFrame":12},"Emotion Regulation","Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) will assess emotion regulation and distress tolerance skills",{"measure":39,"description":40,"timeFrame":12},"Self Efficacy","Trauma Coping Self Efficacy (CSE-T) will assess participants' perceptions of their ability to cope with trauma related distress",{"measure":42,"description":43,"timeFrame":44},"Discharge related outcomes","Discharge Chart Abstraction (see attached): An investigator-created form will gather information on inpatient treatment completion status, successful initiation on relapse prevention medications for opioid use disorder and alcohol use disorder, and continuing care referrals made by the inpatient treatment team.","Completed during the 4-week follow-up appointment once after the participant discharges from the inpatient unit. If participant is still in inpatient, will be completed at the next follow up appointment after discharge (either 8 or 12-week appointments)",{"measure":46,"description":47,"timeFrame":48},"Barriers to Treatment","Barriers to Treatment Participation Scale (BTPS): A WEST specific version of the measure will assess barriers to patient engagement in WEST.","This will be administered during the 4-week follow-up appointment. If this measure was not completed during the 4-week follow-up, participants will complete the measure during the 8 or 12-week appointment.",{"measure":50,"description":51,"timeFrame":52},"Adverse Events","Adverse Events Reporting Form (see participant information document): An investigator- created form used to solicit reporting of any adverse events, additional traumatic exposures, and drug\u002Falcohol overdoses since the last research contact; the traumatic exposure item is taken from the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).","4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.",{"measure":54,"description":55,"timeFrame":12},"Physical Pain","Short-Form Health Survey (SF-12): two items from this measure will assess participant-reported physical pain.",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":56,"whoMasked":56},"NONE",[64,70],{"label":65,"type":66,"description":67,"interventionNames":68},"TAU + Adapted Written Exposure Therapy (WET)","EXPERIMENTAL","Participants in this condition receive everything included in TAU plus 5 individual sessions of WET delivered by a therapist. WET has been adapted for delivery in a residential SUD setting according to expert feedback. Sessions average less than 60 minutes and primarily involve writing about the traumatic experience that is guided by the therapist.",[69],"Behavioral: Written Exposure Therapy",{"label":71,"type":72,"description":73,"interventionNames":74},"TAU","ACTIVE_COMPARATOR","Treatment as Usual will include a variety of standard care services offered in short term residential treatment.",[75],"Behavioral: Treatment as Usual",[77,82],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":56},"BEHAVIORAL","Written Exposure Therapy","Written Exposure Therapy is a brief, evidenced based intervention for PTSD. WET is generally delivered individually across 5 sessions in which the therapist guides the patient through writing exercises. Across exposure sessions, participants experience habituation so that their symptoms decrease by the end of treatment. WET has an established evidence base in general outpatient psychotherapy for PTSD, but has not been adapted or tested in residential SUD treatment settings. Further, the investigators have adapted WET for this setting based on stakeholder and expert feedback.",[65],{"type":78,"name":83,"description":84,"armGroupLabels":85,"otherNames":56},"Treatment as Usual","Treatment as Usual will include a variety of standard care services offered in short term residential treatment. For example, participants receiving TAU will participate in individual case management\u002Fgeneral counseling sessions focused on substance use disorder and its consequences, group based psychoeducation sessions, group based counseling sessions (e.g., relapse prevention planning), individual services with a medical provider and pharmacotherapy (e.g., for withdrawal, relapse prevention, or co-occurring conditions)",[71],[87,92],{"name":88,"role":89,"phone":90,"phoneExt":56,"email":91},"Rebecca Schacht, PhD","CONTACT","410-455-5626","rschacht@umbc.edu",{"name":93,"role":89,"phone":94,"phoneExt":56,"email":95},"Kevin Wenzel, PhD","410-233-1400","kwenzel@marylandtreatment.org",[97],{"facility":98,"status":56,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Maryland Treatment Centers","Baltimore","Maryland","21229","United States","US",{"type":105,"coordinates":106},"Point",[107,108],-76.61219,39.29038,{"lat":108,"lon":107},[111,112],{"name":93,"role":89,"phone":94,"phoneExt":56,"email":95},{"name":113,"role":89,"phone":94,"phoneExt":56,"email":114},"Marc Fishman, MD","mfishman@marylandtreatment.org",{"type":116,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"PRINCIPAL_INVESTIGATOR","Rebecca Schacht","Affiliated Research Scientist",[120],{"name":121,"class":6},"University of Maryland, Baltimore County","100653113","written-exposure-in-substance-treatment-west-30-randomized-controlled-trial-100653113",false,"NCT07782268","Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial","Treating OUD\u002FPTSD in Residential Care: Written Exposure in Substance Treatment (WEST)","WEST","Inclusion Criteria:\n\n* be enrolled in residential SUD treatment at MTC\n* meet criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5\n* be 18 years of age or older\n* have sufficient memory of the index trauma to write about it\n* be sufficiently able to speak, read, and write in the English language to complete WEST therapy and study assessments.\n\nExclusion Criteria:\n\n* Inability to give informed consent for any reason (e.g., cognitive impairment)\n* Presence of acute psychosis that would interfere with study participation\n* Suicide attempt within the past 3 months\n* History of psychiatric hospitalization within the past month\n* Presence of any other psychiatric instability or suicidality that would interfere with study participation\n* Planning to leave residential treatment before WEST could realistically be completed as determined by the investigator\n* Lack of access to a mobile phone after treatment discharge","ALL","18 Years",{"count":133,"type":134},400,"ESTIMATED","INTERVENTIONAL",[137],"NA","The purpose of the current research study is to evaluate the efficacy of the refined Written Exposure in Substance Treatment (WEST) for PTSD among residential SUD patients through a randomized controlled trial. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. Participants will be randomly assigned to WEST + treatment as usual (TAU) or TAU only. The primary outcome is change in PTSD symptoms from pre-intervention to post-intervention. The secondary outcome will be change in SUD outcomes (e.g., treatment completion, reduced opioid and other drug use) and change in non-PTSD mental health outcomes (e.g., depression) from pre-intervention to post-intervention.",[140,141],"Posttraumatic Stress Disorder (PTSD)","Substance Use Disorder (SUD)",[79],"NOT_YET_RECRUITING","2026-08-20",{"date":146,"type":147},"2026-08-24","ACTUAL",{"date":149,"type":134},"2026-09-01",{"date":151,"type":134},"2030-05-31",{"name":5,"class":6},1]