Virginia Commonwealth University Stress Reduction Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change
研究概览
简要总结
This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions and reactions to social conflict.
详细描述
The full research project will be conducted over approximately 2-3 weeks, and will consist of two data collection sessions, one before and one after a 14-day stress reduction training course conducted via a smartphone that participants provide. This course entails instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or a cognitive reappraisal course. Both of these courses -mindfulness training (MT) and cognitive reappraisal training (RT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened)
- •Free of major, uncorrected sensory impairments and cognitive deficits
- •Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day).
- •Adults aged 18 - 55 years of age
- •Right hand dominant (will not be advertised but screened)
- •Personal SmartPhone (Android or iOS operating systems).
- •Naive to meditation practice (will not be advertised but screened)
- •At least a moderate level of perceived stress (scale score > 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress)
排除标准
- •left-handed
- •are unwilling or unable to complete study assessments or treatments
- •report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
- •report a hospitalization over the last 3 months
- •report current drug abuse (e.g., recreational drug use, smoke more than � pack per day, alcohol intake in excess of 2 drinks per day)
- •are prisoners
- •no personal SmartPhone (Android or iOS operating systems)
结局指标
主要结局
Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change
时间窗: Baseline and 16 weeks
Proportion of participants who show a statistically significant change in regional specificity, as measured by fNIRS-recorded blood oxygenation representing markers of emotion reactivity and regulation during observation of video stimuli.
次要结局
- Change in anger response(Baseline and 16 weeks)
- Change in sadness response(Baseline and 16 weeks)
- Change in disgust response(Baseline and 16 weeks)
- Change in intergroup attitudes(Baseline and 16 weeks)
- Change in fear response(Baseline and 16 weeks)
- Change in anxiety response(Baseline and 16 weeks)
- Behavioral willingness to participate in a dyad-based future experiment(16 weeks)