A Randomized Controlled Trial Comparing 3 Formats of Mindfulness Interventions to an Active Control Intervention in a Population With Elevated Levels of Stress: Effects of Subjective and Physiological Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Perceived Stress Scale (PSS-10)
研究概览
简要总结
Stress-related disorders have over the last decade increased and contributed to a worldwide disease burden. At the same time there is limited treatment access for mental health disorders, which has left many people without necessary care. However, in recent years there has been a rise in digital mindfulness interventions. Specifically, these interventions have focused on smartphone-based applications as an effective format for mindfulness training programs. Thus, the goal of this randomized controlled trial is to test the effects of three types of mindfulness programs in a population with elevated stress. The three formats of mindfulness interventions are identical in total training duration but varies in content and intervention length. Specifically, the first intervention consists of programmatic mindfulness content that progress over the course of 30 sessions with a duration of 10 min per session. The second intervention consists of single succinct breathing exercises with no programmatic content over the course of 30 sessions with a duration of 10 min per session. The third intervention consists of mindfulness-based content specifically targeted to people with elevated stress that progress over the course of 20 sessions with a duration of 15 min per session. An active control group listening to an audiobook over the course of 30 sessions with a duration of 10 min per session will be employed and a passive control group.
The study will evaluate outcomes related to subjective stress, sleep quality, mindfulness and physiological effects of stress using HRV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to high perceived stress based on PSS total scores (14-40)
- •Fluent in English
排除标准
- •Regular mindfulness practice for more than 1 month within the last year
- •Medical diagnosis e.g. psychiatric/neurological conditions
- •Low levels of stress (i.e., less than a score of 14 assessed with the PSS)
结局指标
主要结局
Perceived Stress Scale (PSS-10)
时间窗: immediately post intervention
Heart rate variability (HRV)
时间窗: immediately post intervention
HRV data will be recorded continuously during a rest period, acute stress period\*, and recovery period at both pre and post on a subject-by-subject basis. \*The study will use an acute stress manipulation, specifically the CPT (Cold Pressor Task). The CPT is a standardized physiological acute stressor which has been shown to induce stress, reflected in autonomic stress reactivity (e.g. Lupien et al., 2007; Raio et al., 2017).
次要结局
- The Pittsburgh Sleep Quality Index (PSQI)(immediately post intervention)
- Mindful Attention Awareness Scale (MAAS)(immediately post intervention)
