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临床试验/NCT05060393
NCT05060393Unknown不适用

Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder

University of Basel1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
试验地点
1
主要终点
Change from baseline self reported Depression Severity

研究概览

简要总结

The presented randomized-controled study aim to assess the use of internet-based mindfulness intervention via mobile application for 30 days in patients with Major Depressive Disorder (MDD)

详细描述

Mindfulness-based interventions (MBI) proved to be effective in relapse prevention in MDD. Next, MBI in form of free mobile applications can be an effective augmentation of the treatment as usual (TAU) and can fill a gap in the ambulatory care. Given this background, the aim of this randomized controlled study is to assess the effectiveness of additional MBI via mobile app on the symptom severity and stress levels, compared to TAU.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • Depression, current ill

排除标准

  • acute alcohol- and drug dependency, schizophrenia or psychotic disorder, severe somatic illnes, not having smartphone or not willing to use mobile application

结局指标

主要结局

Change from baseline self reported Depression Severity

时间窗: 30 days

Beck Depression Inventory

Change from Baseline Depression Severity

时间窗: 30 days

Hamilton Depression Rating Scale

次要结局

  • Change from baseline tobacco consumption(30 days)
  • Change from baseline heart rate(30 days)
  • Change in consumption of anxiolytics(30 days)
  • Change from baseline alcohol consumption(30 days)
  • Change from baseline blood pressure(30 days)
  • Change from baseline respiratory rate(30 days)

研究者

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

Jan Sarlon

Principal Investigator

University of Basel

研究点 (1)

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