Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial (WEST)
20 augusti 2026 uppdaterad av: Rebecca Schacht, Potomac Health Foundations
Treating OUD/PTSD in Residential Care: Written Exposure in Substance Treatment (WEST)
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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
400
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Kevin Wenzel, PhD
- Telefonnummer: 410-233-1400
- E-post: kwenzel@marylandtreatment.org
Studera Kontakt Backup
- Namn: Rebecca Schacht, PhD
- Telefonnummer: 410-455-5626
- E-post: rschacht@umbc.edu
Studieorter
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Maryland
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Baltimore, Maryland, Förenta staterna, 21229
- Maryland Treatment Centers
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Kontakt:
- Kevin Wenzel, PhD
- Telefonnummer: 410-233-1400
- E-post: kwenzel@marylandtreatment.org
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Kontakt:
- Marc Fishman, MD
- Telefonnummer: 410-233-1400
- E-post: mfishman@marylandtreatment.org
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- be enrolled in residential SUD treatment at MTC
- meet criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5
- be 18 years of age or older
- have sufficient memory of the index trauma to write about it
- be sufficiently able to speak, read, and write in the English language to complete WEST therapy and study assessments.
Exclusion Criteria:
- Inability to give informed consent for any reason (e.g., cognitive impairment)
- Presence of acute psychosis that would interfere with study participation
- Suicide attempt within the past 3 months
- History of psychiatric hospitalization within the past month
- Presence of any other psychiatric instability or suicidality that would interfere with study participation
- Planning to leave residential treatment before WEST could realistically be completed as determined by the investigator
- Lack of access to a mobile phone after treatment discharge
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Tau + anpassad skriftlig exponeringsterapi (våt)
Deltagare i detta tillstånd får allt som ingår i tau plus 5 enskilda sessioner med våt levererade av en terapeut.
Våt har anpassats för leverans i en bostadssud i enligt expertåterkoppling.
Sessioner i genomsnitt mindre än 60 minuter och involverar främst att skriva om den traumatiska upplevelsen som styrs av terapeuten.
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Skriftlig exponeringsterapi är en kort, bevisad baserad intervention för PTSD.
Våt levereras vanligtvis individuellt över 5 sessioner där terapeuten leder patienten genom skrivövningar.
Över exponeringssessioner upplever deltagarna vana så att deras symtom minskar i slutet av behandlingen.
Wet har en etablerad bevisbas i allmän poliklinisk psykoterapi för PTSD, men har inte anpassats eller testats i inställningar för bostäder SUD.
Vidare har utredarna anpassat våt för denna inställning baserad på intressenter och expertåterkoppling.
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Aktiv komparator: TAU
Treatment as Usual will include a variety of standard care services offered in short term residential treatment.
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Behandling som vanligt kommer att inkludera en mängd olika standardvårdstjänster som erbjuds vid kortvarig bostadsbehandling.
Till exempel kommer deltagare som får TAU kommer att delta i enskilda ärendehantering/allmänna rådgivningssessioner fokuserade på droganvändningsstörning och dess konsekvenser, gruppbaserad psykoeducationssessioner, gruppbaserade rådgivningssessioner (t.ex. förebyggande av återfall), individuella tjänster med en medicinsk leverantör och farmakoterapi (t.ex., för uttag, återförsäljning, eller förebyggande av förebyggande)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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PTSD symptom reduction
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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PTSD symptom reduction pre/post 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.
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Days of Substance Use
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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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.
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Substance Use Exposure
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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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.
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Anxiety Symptoms
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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General Anxiety Disorder (GAD-7) will assess symptoms of anxiety.
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Depressive Symptoms
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Patient Health Questionnaire-9 (PHQ-9) will assess depressive symptoms.
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Recovery Capital
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Brief Assessment of Recovery Capital (BARC-10) will assess participant-reported areas of recovery capital. Multidimensional Inventory of Recovery Capital (MIRC): designed to assess the resources a person uses to resolve alcohol or drug problems. |
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Treatment Outcomes
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Treatment Utilization Self-Report Form: an investigator-created form will collect data on ongoing engagement in SUD treatment, mental health, and hospital services. Medication Continuity assessment (see participant information document): will track adherence with medications prescribed during treatment, including addiction-related and other psychotropic medications. |
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Moral Injury
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Moral Injury and Distress Scale (MIDS) will assess exposure to potentially morally injurious events and the possible impacts of moral injury.
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Emotion Regulation
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) will assess emotion regulation and distress tolerance skills
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Self Efficacy
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Trauma Coping Self Efficacy (CSE-T) will assess participants' perceptions of their ability to cope with trauma related distress
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Discharge related outcomes
Tidsram: 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)
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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.
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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)
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Barriers to Treatment
Tidsram: 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.
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Barriers to Treatment Participation Scale (BTPS): A WEST specific version of the measure will assess barriers to patient engagement in WEST.
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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.
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Adverse Events
Tidsram: 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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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/alcohol overdoses since the last research contact; the traumatic exposure item is taken from the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
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4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Physical Pain
Tidsram: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Short-Form Health Survey (SF-12): two items from this measure will assess participant-reported physical pain.
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Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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Samarbetspartners och utredare
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Sponsor
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
31 maj 2030
Avslutad studie (Beräknad)
31 maj 2030
Studieregistreringsdatum
Först inskickad
12 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2026
Första postat (Faktisk)
24 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- WEST 3.0 RCT
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
IPD may be shared with other researchers through a de-identified, secure, electronic data transfer as allowed by the IRB and other regulatory authorities.
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