App-based Stress Management: A Pragmatic Randomized Controlled Trial on the Efficacy of the mHealth Application "Harmony"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Change from baseline stress at 6 weeks and 12 months
研究概览
简要总结
The purpose of this study is to investigate the efficacy of app-based stress prevention via the harmony application in a prospective, interventive, monocentric, explanatory pilot randomized controlled trial (RCT), with participants' subjective stress experience as the primary endpoint.
Research question: Does usage of the app harmony have a positive impact on the subjective experience of stress of its users? Do usage frequency, intensity or width of content engagement influence the efficacy of the intervention?
Hypothesis: We expect improvement of participants' subjective stress experience, stress-related symptoms, subjective well-being, resilient coping, self-efficacy, life satisfaction and goal-attainment.
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
- 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
- 否
入选标准
- •Increased stress level (PSS-10 >= 19; corresponds to one standard deviation (SD 6.42)) above the mean (PSS-10 = 12.57) in a representative sample of the German population (Klein et al., 2016)
- •Fulfillment of technical minimum requirements (internet and smartphone access with suitable operating systems)
- •German language skills at a native level or the ability to use the language at at least B level
- •Written informed consent to participate in the study after being informed about the study
排除标准
- •Inclusion criteria not met.
结局指标
主要结局
Change from baseline stress at 6 weeks and 12 months
时间窗: Baseline, 6-week follow-up, 12-week follow-up
Perceived Stress Scale (PSS-10, Cohen et al., 1983): Self-report measure to assess psychological stress levels; Likert scale: 1 = never, 5 = very often.
Change from baseline stress symptoms at 6 weeks and 12 months
时间窗: Baseline, 6-week follow-up, 12-week follow-up
Stress and Coping Inventory (SCI; Satow, 2024): Self-report measure to assess psychological and physical stress symptoms; Likert scale: 1 = completely true (negative), 4 = not true at all (positive)
次要结局
- Subjective well-being(Baseline, 6-week follow-up, 12-week follow-up)
- Resilient coping(Baseline, 6-week follow-up, 12-week follow-up)
- Self-efficacy(Baseline, 6-week follow-up, 12-week follow-up)
- Life satisfaction(Baseline, 6-week follow-up, 12-week follow-up)
- Goal Attainment(Baseline, 6-week follow-up, 12-week follow-up)
- Experience in Social Systems (EXIS; Hunger et al., 2017)(Baseline, 6-week follow-up, 12-week follow-up)
研究者
Christina Hunger-Schoppe
Prof. Dr.
University of Witten/Herdecke