跳至主要内容
临床试验/NCT02139137
NCT02139137已完成不适用

Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD

Rick Gulizia0 个研究点目标入组 47 人开始时间: 2010年1月最近更新:
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
47
主要终点
Change in Clinician Administered PTSD Scale; Re-experiencing

研究概览

简要总结

The study is designed to evaluate the effect of a novel computer training program on PTSD.

详细描述

Post-traumatic stress Disorder (PTSD) is a chronic and debilitating disorder that affects millions of people each year (Kessler et al., 2005). Although effective psychosocial and pharmacological treatments exist for this disorder, as many as 50 percent of individuals still experience symptoms after treatment (Schottenbaeur et al., 2008). Empirical literature suggests that cognitive deficits may play a role in maintaining symptoms in individuals with PTSD through a variety of mechanisms, including decreased cognitive control over intrusive thoughts (Verwoerd et al., in press) and dysregulation in neural circuitry linking prefrontal cognitive control functions and amygdala activity (McNally, 2007). The goals of the proposed research are to improve the candidate's understanding of cognitive mechanisms of PTSD symptoms while building skills in conducting treatment research. The application aims to test a novel methodology for approaching PTSD treatment based on modification of underlying cognitive mechanisms of the disorder. To this end, 50 participants with PTSD will be randomly assigned to an 8-session executive control training condition designed to improve working memory functioning or a control condition. The aims of this study are 1) To test the effect of a working memory training program on working memory performance and 2) To examine the effects of this program on PTSD symptoms. The research plan is complemented by a set of training goals for the candidate to achieve over the proposed award period. These include 1) training in the use of fMRI and neuropsychological assessment 2) additional coursework and seminars in cognitive science and biostatistics for use in future work, 3) experience with teaching in the undergraduate and graduate setting and presenting original work for publication in preparation for a career in academic research. Taken together, the research and training components of this grant application will facilitate the candidate's long-term goal of conducting treatment outcome and basic mechanism research in PTSD. Moreover, as per the strategic plan outlined by NIMH, this application is designed develop an innovative intervention based on prior clinical research and knowledge of cognitive and neurobiological features of the disorder, and will advance knowledge of mechanisms of fear learning. It is designed to target core cognitive features of the disorder in an effort to reduce symptoms. PUBLIC HEALTH RELEVANCE: Post-traumatic stress disorder impacts millions of Americans, and is associated with significant personal distress as well as societal cost. The current application is designed to examine the effect of a novel working memory training program on PTSD symptoms. This approach is promising in that it may be a cost- effective and accessible method for decreasing symptoms associate with this disorder.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-65
  • Primary DSM-IV diagnosis of PTSD secondary to sexual trauma

排除标准

  • Current trauma or PTSD-focused psychosocial treatment
  • Active suicidality, evidence of substance dependence in the past 6 months
  • Evidence of current or past schizophrenia
  • Bipolar disorder
  • Organic mental disorder

研究组 & 干预措施

High Interference Control Condition

Experimental

Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task

干预措施: Computerized Cognitive Training - active (Other)

Low Interference Control Condition

Active Comparator

Computerized training program requiring participants to minimally practice controlling interference on a cognitive task

干预措施: Computerized cognitive training - sham (Other)

结局指标

主要结局

Change in Clinician Administered PTSD Scale; Re-experiencing

时间窗: Baseline, Week 4

Model estimations of the means and standard deviation of posttreatment score at the mean level of baseline severity reported below. Scale range: 0-40, higher values indicate greater symptom severity

次要结局

  • Change in Depression: Beck Depression Inventory(Baseline, Week 4)
  • Change in General Anxiety: Spielberger State-Trait Anxiety Inventory(Baseline, Week 4)
  • Clinician Administered PTSD Scale Total Score - Responder Status(Week 4)
  • Change in Functional Impairment; Sheehan Disability Scale(Baseline, Week 4)

研究者

发起方
Rick Gulizia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rick Gulizia

Director of Research Affairs

San Diego State University

相似试验