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临床试验/NCT07108608
NCT07108608已完成不适用

Treating OUD/PTSD in Residential Care: Written Exposure in Substance Treatment (WEST).

Potomac Health Foundations1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
PTSD symptom reduction

研究概览

简要总结

The purpose of this pilot non-randomized, uncontrolled clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) as adapted for use 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 question the study aims to answer is: 1) Is the delivery of adapted WET feasible and acceptable in short term residential SUD treatment for individuals with severe SUD?

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
否

入选标准

  • •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 English speaking.

排除标准

  • •Inability to give informed consent for any reason (e.g., cognitive impairment)
  • •Presence of acute psychosis or suicidality that would interfere with study participation
  • •planning to leave residential treatment before WEST could realistically be completed as determined by the investigator

研究组 & 干预措施

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.

干预措施: Written Exposure Therapy (Behavioral)

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.

干预措施: Treatment as Usual (Behavioral)

结局指标

主要结局

PTSD symptom reduction

时间窗: Pre-WEST intervention; post-WEST intervention (approximately 14 days after randomization, but will vary based on when participants complete the intervention); 4-weeks post enrollment; 8-weeks post enrollment; 12-weeks post enrollment.

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

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

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 (1)

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