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临床试验/NCT03950869
NCT03950869已完成不适用

The Role of Expectations in the Development of Intrusive Memories: An Experimental Approach Using the Trauma Film Paradigm

Philipps University Marburg Medical Center2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Frequency and severity of intrusive memories: Daily intrusion diary

研究概览

简要总结

In the experimental study, the well-established trauma film paradigm will be used to investigate the impact of expectations on the development of intrusive memories as a hallmark symptom of PTSD.

详细描述

The study aims to examine the influence of different expectations on the development of intrusive memories by using a well-established experimental paradigm - the trauma film paradigm. In healthy volunteers, intrusion-like symptoms are to be induced with an analogue stressor, i.e., aversive film clip footage (trauma film). After viewing this so-called trauma film, the expectations of intrusions during the following week are manipulated by assigning participants randomly to three different groups. In the first group, negative expectations are induced (experimental group 1), the second group is exposed to positive expectations (experimental group 2) and a third group does not face any kind of manipulation of their expectations (control group). Participants are asked to report occurring intrusions in a diary during the following week and are invited to a subsequent cued laboratory inquiry at 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
Basic Science
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

  • healthy volunteers
  • fluent in German language

排除标准

  • history of traumatic experiences (LEC-5)
  • presence of a mental disorder (SCID-I according to DSM-IV)
  • cut-off in depression screening (PHQ-9)
  • current suicidal thoughts/behavior or non-suicidal self-injury behavior (C-SSRS)
  • medical history of heart disease or epilepsy
  • history of fainting
  • work experience in the medical field (e.g., nurses, paramedics, etc.)
  • visual impairment
  • students of psychology and medicine

结局指标

主要结局

Frequency and severity of intrusive memories: Daily intrusion diary

时间窗: Record of any intrusive memories of the trauma film content for Days 1 to 7 after the experimental manipulation.

Participants are asked to complete a pen-and-paper diary 7 days in a row, reporting on intrusive memories in reference to the trauma film. They are asked to state the number of intrusions per day; each day of the diary is labeled and split into three sections (morning, afternoon, evening), and they are asked to mark in a box in the appropriate section when they experienced an intrusion. For each intrusion, they indicate the quality of the intrusion (image, thought or both), the intensity of and distress caused by the intrusion both on a scale ranging from 0 ("not at all") to 10 ("extremely"), the content of the intrusion, and the situation in which the intrusion occurred. Intrusive memory frequency across 7 days are calculated, whilst higher sum scores represent more intrusions. Severity of intrusions are calculated by combining the average score of the intensity and distress scale across all intrusions, whilst higher values indicate higher intensity/distress of reported intrusions.

次要结局

  • Distress caused by the trauma film: Impact of Event Scale-Revised (IES-R)(At the follow-up measurement (7 days after the experimental manipulation).)
  • Laboratory assessment of intrusive memories: Intrusion Provocation Task (IPT)(At the follow-up measurement (7 days after the experimental manipulation).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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