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临床试验/NCT05292560
NCT05292560已完成不适用

A Randomized Controlled Trial on the Effectiveness of a Positive Psychology App for Adults in the General Population Dealing With Negatives Consequences of the Corona Crisis

University of Twente2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年4月4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
250
试验地点
2
主要终点
Mental well-being

研究概览

简要总结

The corona crisis has a negative impact on the mental wellbeing of the Dutch population. Positive psychology exercises (PPOs) can potentially improve mental well-being and reduce mild and moderate psychological complaints. Previous research has shown moderate to large effects of PPOs on well-being in people with reduced wellbeing and psychological symptoms at baseline. The University of Twente developed an app (Training in Positivity; TiP) based on an effective intervention. The goal of this study is to investigate the effectiveness of TiP in the general population in people experiencing reduced mental wellbeing as a result of the corona crisis. People using the app will be compared to a waiting list control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

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

  • The participant is at least 18 years old
  • The participant has an e-mail address and is in possession of a smartphone or tablet with access to the internet.
  • The participant is willing to do a positive psychology exercise 6 days a week for 3 weeks
  • The participant has sufficient command of the Dutch language to be able to complete questionnaires and exercises.
  • The participant gives consent to participate in the study using the online informed consent procedure.

排除标准

  • The presence of severe anxiety symptoms: a score of 15 or higher on the Generalized Anxiety Disorder 7 items (GAD-7)
  • The presence of severe depressive symptoms: a score of 20 or higher on the Patient Health Questionnaire (PHQ-9).

结局指标

主要结局

Mental well-being

时间窗: Change from baseline mental well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2).

Mental well-being measured with the 14-item Mental Health Continuum-Short Form. Scores are calculated as mean scores and can range from 0 to 5. Higher scores indicate more mental well-being.

次要结局

  • General self-efficacy(Change from baseline general self-efficacy at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2))
  • Self-compassion(Change from baseline self-compassion at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2))
  • Anxiety symptoms(Change from baseline anxiety symptoms at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2))
  • Depression symptoms(Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2))
  • Ability to adapt(Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2))
  • Savoring(Change from baseline savoring at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2))
  • Positive reframing(Change from baseline positive reframing at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2))
  • Spiritual well-being(Change from baseline spiritual well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2))

研究者

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

Jannis Kraiss

Assistant Professor

University of Twente

研究点 (2)

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