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临床试验/NCT03760601
NCT03760601已完成不适用

Intrusive Memories of Trauma Experienced by Young Refugees: Using Single Case Experimental Design to Investigate a Brief Cognitive Intervention Involving Computer Gameplay: An Extension

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年3月25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
5
试验地点
1
主要终点
Change in number of intrusive memories of trauma

研究概览

简要总结

This research study is designed to investigate the use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. The design is a single case experimental AB design with optional replication (ABAB). Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue to use the technique self-guided in the subsequent week. Follow ups are conducted after each week to monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase.

详细描述

This research study follows from ClinicalTrials.gov ID: NCT03525158, with a focus on the ABAB design and adding additional questions e.g. on concentration, emotion and functioning, and with the possibility of focusing on 1 intrusive memory at a time with associated distress ratings as part of the procedure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Refugee or asylum seeker
  • Experiencing intrusive memories of trauma
  • Have access to a smartphone
  • Able to speak or read the study material in Swedish, English, Arabic or Farsi
  • Able to attend five to six meetings with a researcher

排除标准

  • Exhibit psychotic symptoms or other symptoms of severe mental illness

结局指标

主要结局

Change in number of intrusive memories of trauma

时间窗: Change between baseline week 1 and Intervention week 1

Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) over one week.

次要结局

  • Self-guided intervention adherence - usage of the gameplay intervention in daily life(Intervention week 1)
  • Impact of intrusive memories on concentration, control, sleep and stress - ratings(Baseline week 1 and Intervention week 1)
  • Rating of how long intrusive memories disrupted concentration on average(Baseline week 1 and Intervention week 1)
  • Impact of intrusive memories - open ended questions(Baseline week 1 and Intervention week 1)
  • Impact of the intervention on concentration, emotion and functioning - ratings(Intervention week 1)
  • Subjective impact of the intervention - open ended questions(Intervention week 1)
  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS)(Baseline week 1 and intervention week 1)
  • Feasibility and acceptability ratings for using a smartphone game-play intervention(Intervention week 1)
  • Feasibility and acceptability - open ended questions(Intervention week 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Holmes

Professor Emily Holmes

Karolinska Institutet

研究点 (1)

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