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临床试验/NCT06129435
NCT06129435招募中不适用

Effects of Behavioral Tasks on Memory Reconsolidation and Trauma-Related Symptoms: A Randomized Clinical Trial

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Momentary Assessment of Distress Scale

研究概览

简要总结

The purpose of this study is to investigate the effects of a visuospatial task on memory reconsolidation and trauma symptoms for trauma-exposed individuals after exposure to traumatic memory reactivation paradigm.

详细描述

It is estimated that over 70% of individuals worldwide have experienced a trauma within their lifetime. Many people spontaneously recover without formal intervention or treatment after exposure to a traumatic event, however, some individuals may develop intrusive trauma-related memories, avoidance, negative changes in cognitions or mood, or changes in arousal and reactivity, resulting in clinical or sub-clinical symptoms of posttraumatic stress disorder (PTSD). Although empirically supported trauma-focused treatments currently exist (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy), they are typically economically expensive, time consuming, require therapy sessions with a specialized provider, and have moderate to high nonresponse and dropout rates (20-50%). As such, there is a need for novel and palatable prevention and treatment strategies for PTSD.

Innovative preclinical research has revealed that, after memory retrieval, previously consolidated memories temporarily enter a labile state and become vulnerable to pharmacological and behavioral disruptors. The impermanence of memory has potential clinical applications for the secondary prevention and treatment of memory-based psychiatric disorders (e.g., anxiety disorder and PTSD). Several randomized controlled experiments with healthy volunteers have shown that engaging in a taxing visuospatial task (playing the game Tetris) 24 hours, or up to four days, after viewing traumatic film (analogue trauma) significantly reduced the subsequent number of intrusive memories relative to those who completed no task or who played a control game. Similar findings have been replicated among individuals with PTSD. One study found that participants with complex and longstanding PTSD demonstrated a decrease in intrusive trauma memories after undergoing a trauma memory reminder and playing Tetris for 25 minutes in an inpatient treatment setting. Similarly, participants with a history of traumatic birth who underwent a trauma memory reminder and a single session of Tetris gameplay displayed significant reduction of intrusive memory frequency at one-month follow-up. Taken together, these findings suggest that visuospatial disruptors (i.e., playing Tetris) may have clinical utility in preventing or treating PTSD.

The overarching objective of this study is to investigate the effects of a visuospatial task on memory reconsolidation and trauma symptoms among trauma-exposed individuals after exposure to a trauma memory reactivation paradigm. To accomplish this, the investigators will conduct a three-arm placebo-controlled randomized clinical trial. The three treatment conditions of the proposed study are: (1) visuospatial task (VST); (2) word association task (WAT); or (3) no treatment control condition (NT-CTRL).

The current study intends to expound upon this emerging area of research by conducting a randomized controlled trial investigating the effects of behavioral disruptors (i.e., playing Tetris, playing a word association game, or no-game play control) after a trauma memory reactivation procedure among a trauma-exposed population.

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
All
接受健康志愿者

入选标准

  • Adults aged 18 to 65
  • Fluent in written and spoken English
  • Has access to the internet
  • Access to a computer (laptop or desktop) with a camera that has video and audio recording capability
  • History of trauma exposure to either a motor vehicle (MVC), sexual assault, physical assault, or combat.

排除标准

  • Insufficient emotional reactivity to the trauma memory reactivation video clip (<5 the Peak Subjective Units of Distress Scale)
  • Presence of significant suicidality or a history of a suicide attempt within the past 6 months
  • History of psychosis within the past 6 months
  • Changes in psychotropic medication (≤ 8 weeks)
  • Currently receiving trauma-focused psychotherapy

研究组 & 干预措施

No Game Play (NT-CTRL)

No Intervention

Word Association Task (WAT)

Sham Comparator

干预措施: Word Association Task (WAT) (Behavioral)

Visuospatial Task (VST)

Experimental

干预措施: Visuospatial Task (VST) (Behavioral)

结局指标

主要结局

Momentary Assessment of Distress Scale

时间窗: Change from Baseline to Two-week Follow-up

The Momentary Assessment of Distress Scale (MADS) is a customizable sliding scale used to measure continuous real-time changes in levels of subjective emotional stress on scale from 0 (no distress) to 10 (extreme distress). The MADS is used to index changes in emotional reactivity during exposure to a trauma memory reactivation cue.

次要结局

  • Subjective Units of Distress Scale - Peak(Change from Baseline to Two-week Follow-up)
  • Posttraumatic Stress Disorder Checklist(Change from Baseline to Two-week Follow-up)
  • Connor-Davidson Resilience Scale(Change from Baseline to Two-week Follow-up)
  • Posttraumatic Cognition Inventory(Change from Baseline to Two-week Follow-up)
  • Posttraumatic Safety Behaviors Inventory(Change from Baseline to Two-week Follow-up)
  • Posttraumatic Growth Inventory(Change from Baseline to Two-week Follow-up)
  • Trauma Coping Self-Efficacy Scale(Change from Baseline to Two-week Follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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