Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial (WEST)
20 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
400
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kevin Wenzel, PhD
- Número de telefone: 410-233-1400
- E-mail: kwenzel@marylandtreatment.org
Estude backup de contato
- Nome: Rebecca Schacht, PhD
- Número de telefone: 410-455-5626
- E-mail: rschacht@umbc.edu
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21229
- Maryland Treatment Centers
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Contato:
- Kevin Wenzel, PhD
- Número de telefone: 410-233-1400
- E-mail: kwenzel@marylandtreatment.org
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Contato:
- Marc Fishman, MD
- Número de telefone: 410-233-1400
- E-mail: mfishman@marylandtreatment.org
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Terapia de exposição escrita adaptada para Tau + (úmido)
Os participantes desta condição recebem tudo o que incluiu no Tau, mais 5 sessões individuais de molhado entregues por um terapeuta.
O Wet foi adaptado para entrega em um ambiente residencial de SUD, de acordo com o feedback de especialistas.
As sessões têm uma média de menos de 60 minutos e envolvem principalmente a escrita sobre a experiência traumática que é guiada pelo terapeuta.
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A terapia por exposição por escrito é uma intervenção breve e evidenciada para o TEPT.
O molhado é geralmente entregue individualmente em 5 sessões nas quais o terapeuta guia o paciente através de exercícios de escrita.
Nas sessões de exposição, os participantes experimentam habituação para que seus sintomas diminuam até o final do tratamento.
O WET possui uma base de evidências estabelecida em psicoterapia ambulatorial geral para TEPT, mas não foi adaptada ou testada em ambientes residenciais de tratamento SUD.
Além disso, os pesquisadores se adaptaram a essa configuração com base nas partes interessadas e feedback de especialistas.
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Comparador Ativo: TAU
Treatment as Usual will include a variety of standard care services offered in short term residential treatment.
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O tratamento como de costume incluirá uma variedade de serviços de atendimento padrão oferecidos em tratamento residencial de curto prazo.
For example, participants receiving TAU will participate in individual case management/general 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)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PTSD symptom reduction
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Days of Substance Use
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
31 de maio de 2030
Conclusão do estudo (Estimado)
31 de maio de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
12 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de agosto de 2026
Primeira postagem (Real)
24 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- WEST 3.0 RCT
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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