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临床试验/NCT07495917
NCT07495917招募中不适用

A Tetris Intervention Following Subliminal Reactivation for Reducing Intrusive Memories in Trauma-exposed Individuals: a Randomized Controlled Trial

Shaanxi Normal University1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年4月10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
发起方
入组人数
106
试验地点
1
主要终点
Number of trauma-related intrusive memories

研究概览

简要总结

Intrusive memories of traumatic events are a core feature of Post-Traumatic Stress Disorder (PTSD) and can cause substantial distress and functional impairment. Existing trauma-focused treatments are effective but often require deliberate recollection of traumatic experiences, which can be distressing for some individuals.

Previous experimental studies in healthy participants found that masked reactivation of trauma-related cues, followed after a brief interval by a visuospatial interference task using Tetris gameplay, reduced the frequency and emotional intensity of intrusive memories. Building on these findings, the present randomized controlled trial evaluates the efficacy of this intervention in trauma-exposed individuals experiencing three or more intrusive memories per week.

详细描述

This randomized controlled trial aims to evaluate an intervention for reducing intrusive memories in trauma-exposed individuals. Participants will be randomly assigned to either an intervention group or a control group.

Before the intervention, participants assigned to the intervention group will provide images related to their traumatic experiences for use in the subsequent memory-reactivation procedure. The intervention group will undergo trauma-related memory reactivation, a music interval, and a visuospatial interference task, whereas the control group will complete only the visuospatial task. Intrusive memories and related symptoms will be assessed during follow-up.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meet DSM-5 PTSD Criterion A (eg, exposure to actual or threatened death). Have experienced one or more traumatic events.
  • Experienced three or more intrusive memories during the baseline week.
  • Have internet access and have access to a personal computer.
  • Be willing to provide consent and able to complete study procedures and be contacted by the study team.

排除标准

  • Have fewer than three intrusive memories during the baseline week.
  • A current diagnosis of schizophrenia, obsessive-compulsive disorder (OCD), a severe personality disorder judged to interfere with treatment adherence, or acute suicidal behavior.
  • Have severe substance dependence.

研究组 & 干预措施

Unconscious Reactivation

Experimental

Participants in this experimental arm will undergo subliminal (unconscious) reactivation of trauma-related memories. Trauma-related cues are presented below the threshold of conscious awareness. Following reactivation, participants complete a 10-minute music-listening task, after which they perform a computerized visuospatial interference task (Tetris) with mental rotation instructions.

干预措施: Subliminal Reactivation Followed by Visuospatial Interference (Behavioral)

No Reactivation Control

Sham Comparator

Participants in this control arm will not undergo trauma memory reactivation. They will proceed directly to a computerized visuospatial task (Tetris) with mental rotation instructions. This condition serves as a comparator for evaluating the effects of the experimental intervention while controlling for the nonspecific effects associated with engagement in the visuospatial task.

干预措施: Computer-based Visuospatial Task (Tetris) (Behavioral)

结局指标

主要结局

Number of trauma-related intrusive memories

时间窗: Day 66 - 72(all arms) controlling for baseline week

Number of trauma-related intrusive memories assessed via a daily diary.

Number of trauma-related intrusive memories

时间窗: Day 30 - 36(all arms) controlling for baseline week

Number of trauma-related intrusive memories assessed via a daily diary.

次要结局

  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)(Baseline (day 0) and day 73 (all arms))
  • Number of trauma-related intrusive memories(Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week)
  • Intrusive memory ratings(Day 24, day 48, day 72, 2 months after the last intervention(all arms))
  • Post-Intervention Questionnaire(Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms))
  • PTSD Checklist for DSM-5 (PCL-5)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
  • Impact of Event Scale-Revised (IES-R)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
  • Beck Depression Inventory-II (BDI-II)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
  • State-Trait Anxiety Inventory-State version (STAI-S)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
  • Work and Social Adjustment Scale (WSAS)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
  • Number of trauma-related intrusive memories(Day 12 - 18 (all arms) controlling for baseline week)
  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)(Baseline (day 0) and day 37 (all arms))
  • Intrusive memory ratings(Baseline(day 0), Day 18, day 36, 2 months after the last intervention(all arms))
  • Post-Intervention Questionnaire(Day1, 2, 10, 11, 19, 20, 28, 29 (all arms))
  • PTSD Checklist for DSM-5 (PCL-5)(Baseline(day 0), day19, day37, 2 months after the last intervention(all arms))
  • Impact of Event Scale-Revised (IES-R)(Baseline(day 0), day19, day37, 2 months after the last intervention(all arms))
  • Beck Depression Inventory-II (BDI-II)(Baseline(day 0), day19, day37, 2 months after the last intervention(all arms))
  • State-Trait Anxiety Inventory-State version (STAI-S)(Baseline(day 0), day19, day37, 2 months after the last intervention(all arms))
  • Work and Social Adjustment Scale (WSAS)(Baseline(day 0), day19, day37, 2 months after the last intervention(all arms))

研究者

发起方
Shaanxi Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhu Zijian

Associate Professor

Shaanxi Normal University

研究点 (1)

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