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临床试验/NCT05246800
NCT05246800已完成不适用

The Effectiveness of a Non-guided Mindfulness Application on Perceived Stress in a Non-clinical Dutch Population: a Randomized Controlled Trial

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 587 人开始时间: 2018年3月1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
587
试验地点
1
主要终点
Change in perceived stress levels between baseline, end of program and after six months

研究概览

简要总结

Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) in reducing stress. The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months.

详细描述

Background:

Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) in reducing stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth.

Objectives:

The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months.

Methods:

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
Single (Participant)

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in perceived stress levels between baseline, end of program and after six months

时间窗: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization

Measured with Perceived stress scale (PSS). The 14 item Dutch version was used. All items are rated on a 4-point Likert scale, with higher scores meaning more perceived stress.

次要结局

  • Change in Four dimensional symptoms: : Distress (16 items), Depression (6 items), Anxiety (12 items) and Somatization between baseline, end of program and after six months(baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization)
  • Change in burnout symptoms between baseline, end of program and after six months(baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization)

研究者

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

Leonieke Kranenburg

Principal Investigator

Erasmus Medical Center

研究点 (1)

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