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临床试验/NCT05729789
NCT05729789招募中不适用

Investigating Group Written Exposure Therapy for Posttraumatic Stress Disorder: A Pilot Study

St. Joseph's Healthcare Hamilton2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
63
试验地点
2
主要终点
Change from baseline on the PTSD Checklist for DSM-5 (PCL-5)

研究概览

简要总结

The goal of this clinical trial is to test if Written Exposure Therapy (WET) works well in a group setting in patients with post-traumatic stress disorder (PTSD).

The main questions it aims to answer are:

  • Does group WET lead to a reduction in symptoms of PTSD?
  • Is group WET better at reducing the number of patients that drop out of treatment in comparison to group Cognitive Processing Therapy (CPT)?

Participants will:

  • Attend 6 weekly sessions of group WET that will be delivered online by two therapists (psychologist and social worker)
  • Complete questionnaires relating to their symptoms at different points throughout the treatment

Researchers will evaluate change in PTSD symptoms over time for people who participate in group WET. They will also compare the results of group WET to the results of group CPT to see if group WET shows a similar reduction in symptoms of PTSD and fewer treatment drop-outs.

详细描述

The primary objective of this study is to evaluate the effectiveness of group WET (G-WET) in reducing symptoms of PTSD in an outpatient hospital setting. In order to do so, we will evaluate outcomes of G-WET from pre- to post-treatment and at one month follow-up. We will also compare outcomes of G-WET to published benchmarks of individual WET outcomes and to a representative cohort of individuals who participate in group CPT at our clinic. A secondary aim of the study is to evaluate attendance and drop-out rates for group WET. In order to achieve this, we will recruit a sample of 63 individuals between the ages of 18 and 65 to participate in a group WET 6-session protocol (1 orientation session and 5 WET sessions) from an outpatient anxiety and related disorders clinic waitlist for group CPT. Participants will complete measures assessing PTSD, related symptoms (e.g., depression, anxiety) and group cohesion at pre-treatment, post-treatment, and 1-month follow-up. Attendance and drop-out rates will also be recorded. We hypothesize that group WET will be associated with significant reductions in PTSD symptoms and related symptoms and low dropout rates (i.e., less than 10%). We also hypothesize that outcomes for group WET will be comparable to those for group CPT and published individual WET benchmarks.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 and older
  • Diagnosis of PTSD
  • Able to provide written informed consent and can read and write in English

排除标准

  • Diagnosis of an active severe substance use disorder (SUD)
  • Diagnosis of a psychotic disorder (schizophrenia, schizoaffective disorder, etc.)
  • Untreated active psychotic, manic or hypomanic symptoms
  • Has attempted suicide in the 2 months prior to beginning treatment
  • Has engaged in high-risk self-harm (e.g., cutting, burning, asphyxiation) in the 2 months prior to beginning treatment
  • Has completed CPT in the past
  • Has completed another active PTSD treatment, such as Prolonged Exposure or EMDR within the last year

结局指标

主要结局

Change from baseline on the PTSD Checklist for DSM-5 (PCL-5)

时间窗: Weekly at each group session, 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.

20-item self-report questionnaire assessing symptoms of PTSD over the past week.

次要结局

  • Change from baseline on the Posttraumatic Cognitions Inventory (PTCI)(1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.)
  • Change from baseline on the Difficulties in Emotion Regulation Scale (DERS)(1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.)
  • Change from baseline on the Illness Intrusiveness Rating Scale (IIRS)(1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.)
  • Group Cohesion Scale-Revised (GCS-R)(1 week after treatment ends.)
  • Change from baseline on the Depression, Anxiety, Stress Scale -21 Item Version (DASS-21)(1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenna Boyd

Dr. Jenna Boyd

St. Joseph's Healthcare Hamilton

研究点 (2)

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