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临床试验/NCT04333667
NCT04333667已完成不适用

Effectiveness of Mindfulness-based Internet Intervention Still Me: a Randomized Controlled Trial

Vilnius University1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2020年4月14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
125
试验地点
1
主要终点
Change on International Trauma Questionnaire

研究概览

简要总结

The aim of the study is to assess the effectiveness of a mindfulness-based internet intervention for post-traumatic stress disorder symptoms.

详细描述

Intervention is going to take the form of a mindfulness-based internet intervention consisting of eight modules. The themes include awareness and nonjudgment of senses, emotions, and thoughts. These themes were chosen after considering topics that might be the most useful for individuals who experience post-traumatic disorder symptoms. Each module consists of psychoeducation and exercise (audio records mostly) parts. Psychologist can be reached on demand.

The effect of the intervention will be compared against a waiting list control group. Intervention is in Lithuanian.

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
None

入排标准

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

入选标准

  • at least 18-years-old;
  • understand Lithuanian;
  • internet access and device for that;
  • at least one traumatic event during lifetime;
  • post-traumatic stress disorder symptoms.

排除标准

  • an acute case of psychiatric care;
  • interpersonal violence;
  • alcohol / drug addiction;
  • cannot participate.

结局指标

主要结局

Change on International Trauma Questionnaire

时间窗: Pre-treatment, after 8 weeks, 3 months post-treatment

Changes on post-traumatic stress disorder are measured. International Trauma Questionanaire (ITQ, Cloitre et al., 2018) is a self-report measure and consists of 18 questions. All items are answered on a 5-point Likert scale that ranges from 0 (not at all) to 4 (extremely). Higher score indicates more pronounced symptoms.

次要结局

  • Change on Patient Health Questionnaire-9(Pre-treatment, after 8 weeks, 3 months post-treatment)
  • Change on General anxiety disorder(Pre-treatment, after 8 weeks, 3 months post-treatment)
  • Change on Adjustment disorder - New Module 8(Pre-treatment, after 8 weeks, 3 months post-treatment)
  • Change on Positive Mental Health Scale(Pre-treatment, after 8 weeks, 3 months post-treatment)
  • Change on Five Facet Mindfulness Questionnaire-Short form(Pre-treatment, after 8 weeks, 3 months post-treatment)

研究者

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

Evaldas Kazlauskas

Professor

Vilnius University

研究点 (1)

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