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临床试验/NCT06296940
NCT06296940已完成不适用

Project WEST (Written Exposure in Substance Treatment) Part 2

Potomac Health Foundations2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Efficacy of WET

研究概览

简要总结

The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. 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. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years old
  • Fluent in English
  • Cognitively able to provide consent to the research
  • Enrolled in inpatient treatment at the clinical site where the research takes place
  • Meet criteria for probable PTSD based on PCL-5 score
  • Be early enough in their residential stay to allow time to complete the WET protocol
  • Have a clear memory of the traumatic event so they are able to write about itin detail

排除标准

  • Reports significant suicidal or homicidal ideation with intent, untreated psychosis, or have other health limitations that may interfere with their ability to participate in the research

结局指标

主要结局

Efficacy of WET

时间窗: Pre/post intervention window (approximately 3 weeks)

PTSD symptom reduction pre/post intervention by treatment arm as measured by the posttraumatic checklist for DSM-5 (PCL-5). The PCL-5 is a self-report questionnaire yielding scores ranging from 0-80 with higher scores indicating greater symptomology.

次要结局

  • Feasibility of WET delivered in residential SUD treatment context(Up to 4 weeks, or until the participant discharges from residential treatment (whichever comes first).)
  • Acceptability of WET delivered in residential SUD treatment context(Collected post intervention window (approximately 3 weeks from randomization))

研究者

发起方
Potomac Health Foundations
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Schacht

Affiliated Research Scientist

Potomac Health Foundations

研究点 (2)

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