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临床试验/NCT02766296
NCT02766296已完成不适用

Emotional Working Memory Training for Veterans With Elevated Trauma-related Symptoms

Milwaukee VA Medical Center2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年5月1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
33
试验地点
2
主要终点
Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up

研究概览

简要总结

PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The current project aims to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. Participants will be randomly assigned to one of the two computerized training programs. At baseline, post-training, and 1-month follow-up, participants will be assessed with respect to their emotional symptoms and working memory-related cognitive performance. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program.

详细描述

PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The long-term objective is to develop an effective cognitive treatment program that can reduce such intrusive cognitions observed among individuals who have been exposed to a significant trauma. The specific objective is to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. eWMT is designed to improve the individual's ability to stay focused on the target and filter out irrelevant information from their working memory, which is expected to improve trauma-related emotional symptoms via the improvement of working memory functioning.

Individuals who display elevated trauma symptoms will be randomly assigned to one of two eWMT conditions: (a) adjustable n-back training (i.e., potent working memory training program), and (b) fixed 1-back training (i.e., training that delivers a limited dose). Participants will be blinded to ensure objective assessment of the intervention effects. Before and after the eWMT intervention, all participants will undergo an assessment session that aims to assess each individual's emotional symptoms and working memory-related cognitive performance. Further, following completion of procedure, participants will be invited for a follow-up assessment to assess the long-term effect of training.

The eWMT intervention will be delivered via Internet. Thus, the current intervention is a home-based Internet intervention, which provides an important context for testing and developing a cost-efficient, accessible, and effective intervention program for many individuals suffering from exposure to traumas. Each training session will take about 20 minutes, and all participants in both conditions will receive a total of 15 training sessions. Participants will be guided to complete an average of 3 training sessions every week for a total duration of approximately 5 weeks.

Investigators hypothesize that individuals who undergo the active eWMT will display a greater improvement in overall working memory performance and a greater reduction in trauma-related symptoms, compared to individuals who undergo the less effective control training program. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program that can reach out to many individuals who suffer from exposure to traumas.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Fluently speaks English
  • The PTSD Checklist (PCL-5) total score >= 38

排除标准

  • No access to a private computer with high-speed Internet that can be used privately.
  • Elevated suicidality
  • History of psychotic disorders (e.g., schizophrenia)
  • Severe substance use disorder (as per DSM-5 criteria)
  • History of severe brain injury or organic mental syndrome

研究组 & 干预措施

Active Emotional Working Memory Training

Experimental

Each participant will receive 15 sessions (each lasting 20 minutes) over a 5 week. This will be Internet-based cognitive training based on the adaptive dual n-back paradigm.

干预措施: Active Emotional Working Memory Training (Behavioral)

Control Working Memory Training

Placebo Comparator

Participants in this condition will receive 15 sessions (each lasting 20 minutes) over a 5-week period. This will also be home-based training over the Internet. This training will be based on a fixed 1-back training program.

干预措施: Control Working Memory Training (Behavioral)

结局指标

主要结局

Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up

时间窗: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)

PTSD Checklist (PCL-5)

次要结局

  • Change in working memory performance from baseline to post-training and 1-month follow-up(At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training))

研究者

发起方
Milwaukee VA Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Sadie Larsen

Assistant Professor

Milwaukee VA Medical Center

研究点 (2)

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