Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial (WEST)
20 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
400
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Kevin Wenzel, PhD
- Numero di telefono: 410-233-1400
- Email: kwenzel@marylandtreatment.org
Backup dei contatti dello studio
- Nome: Rebecca Schacht, PhD
- Numero di telefono: 410-455-5626
- Email: rschacht@umbc.edu
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21229
- Maryland Treatment Centers
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Contatto:
- Kevin Wenzel, PhD
- Numero di telefono: 410-233-1400
- Email: kwenzel@marylandtreatment.org
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Contatto:
- Marc Fishman, MD
- Numero di telefono: 410-233-1400
- Email: mfishman@marylandtreatment.org
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Terapia di esposizione scritta adattata tau + (bagnato)
I partecipanti a questa condizione ricevono tutto ciò che è incluso in Tau più 5 sessioni individuali di bagnato consegnate da un terapeuta.
WET è stato adattato per la consegna in un ambiente SUD residenziale in base al feedback degli esperti.
Le sessioni in media meno di 60 minuti e comportano principalmente la scrittura dell'esperienza traumatica guidata dal terapeuta.
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La terapia di esposizione scritta è un breve intervento basato su evidenza per PTSD.
Il bagnato viene generalmente consegnato individualmente attraverso 5 sessioni in cui il terapeuta guida il paziente attraverso gli esercizi di scrittura.
Attraverso le sessioni di esposizione, i partecipanti sperimentano l'abituazione in modo che i loro sintomi diminuiscano entro la fine del trattamento.
WET ha una base di prove consolidata in psicoterapia ambulatoriale generale per PTSD, ma non è stata adattata o testata in contesti di trattamento SUD residenziale.
Inoltre, gli investigatori si sono adattati a questo ambiente in base al feedback degli stakeholder e degli esperti.
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Comparatore attivo: TAU
Treatment as Usual will include a variety of standard care services offered in short term residential treatment.
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Il trattamento come al solito includerà una varietà di servizi di assistenza standard offerti nel trattamento residenziale a breve termine.
Ad esempio, i partecipanti che ricevono tau parteciperanno a sessioni di gestione dei casi individuali/consulenza generale incentrati sul disturbo da uso di sostanze e sulle sue conseguenze, sessioni di psicoeducazione a base di gruppo, sessioni di consulenza basate sul gruppo (ad esempio, pianificazione della prevenzione delle ricadute), servizi individuali con un fornitore medico e una farmacoterapia (ad esempio, per ritiro, prevenzione della recupero o condizioni di evento co-eventi))
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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PTSD symptom reduction
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Days of Substance Use
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
31 maggio 2030
Completamento dello studio (Stimato)
31 maggio 2030
Date di iscrizione allo studio
Primo inviato
12 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
20 agosto 2026
Primo Inserito (Effettivo)
24 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- WEST 3.0 RCT
Piano per i dati dei singoli partecipanti (IPD)
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SÌ
Descrizione del piano IPD
IPD may be shared with other researchers through a de-identified, secure, electronic data transfer as allowed by the IRB and other regulatory authorities.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .