Mindfulness-Based Intervention for Stress Reduction in Adult Singaporeans a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Self-reported Stress
研究概览
简要总结
This pilot study investigates self-administered mindfulness (SAM) as a stress reduction intervention, serving as a feasibility assessment for a larger multi-site trial. The research addresses gaps in mindfulness literature, particularly timely given that stress profoundly affects individuals' lives, shaping their thoughts, behaviors, and emotional experiences (Aldwin, 2007; Lazarus & Folkman, 1984), and plays a significant role in conditions like depression and anxiety (Yang et al., 2015).
The study implements a sham meditation control condition, improving upon passive controls that often yield inflated effect sizes (Patterson et al., 2016). The methodology incorporates both subjective measures, addressing limitations noted by Nichols et al. (2008), and heart rate variability (HRV) measurements. HRV has proven useful for its sensitivity to stress-induced changes (Goldberger et al., 2001), with higher values indicating better parasympathetic recovery (Shaffer & Ginsberg, 2017; Michels et al., 2013).
Set in Singapore, where stress management is a significant concern (Chodavadia et al., 2023), the study builds on Kabat-Zinn's (2003, 2006) definition of mindfulness. Unlike traditional programs, these interventions are more accessible (Spijkerman et al., 2016).
Recent meta-analyses show mixed findings: some identified small but significant effects (Cavanagh et al., 2018; Taylor et al., 2021), while others found no evidence of effectiveness after accounting for publication bias (Sparacio et al., 2024a). The study considers Singapore's unique cultural position (Li, Ngin, & Teo, 2007) and utilizes smartphone-based HRV monitoring, supported by research validating PPG technology (Guede-Fernández et al., 2020).
Through its comprehensive approach and robust design, this pilot study aims to establish a foundation for future research while providing insights into SAM's effectiveness as a stress reduction technique.
详细描述
This pilot study will implement a fully decentralized approach to investigate self-administered mindfulness (SAM) interventions, leveraging digital tools to streamline the research process without requiring physical interaction between research teams and participants. The decentralized framework particularly suits SAM interventions due to their inherent flexibility and seamless integration into participants' daily routines.
The study will address critical methodological gaps in mindfulness research through a rigorous randomized, double-blind, two-arm parallel-groups design. To differentiate between genuine effects and expectation-related processes, the study will employ a sham meditation control condition, where participants will be led to believe they are practicing meditation. This control condition will maintain structural equivalence with the mindfulness intervention while deliberately excluding two fundamental processes: attentional anchoring and guidance on cultivating mindful meta-cognitive qualities.
The study will utilize a comprehensive digital infrastructure for data collection and intervention delivery. The current clinical trial will be conducted over a three-day period and will be administered entirely remotely, with participants engaging from their homes by accessing a Qualtrics link.
For objective stress measurement, the study will utilize smartphone-based heart rate variability (HRV) assessment via a validated app employing photoplethysmogram (PPG) technology. This approach is consistent with established methods for assessing physiological markers of stress during resting states. The smartphone-based measurement strategy will enable participants to engage in the study from their homes, potentially enhancing ecological validity and participant retention.
The study will implement a robust system for participant management and data security. Phone numbers will be retained temporarily for specific operational purposes: preventing multiple submissions, facilitating study material delivery, and ensuring compensation via an electronic payment system. To maintain anonymity, all collected data except phone numbers will be de-identified. The study coordinator will implement checks for duplicate numbers to maintain data integrity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 21 years old.
- •Possess a smartphone capable of running the study applications with internet access.
- •Be fluent in the English language.
- •Have sufficient vision and hearing to complete the study procedures.
排除标准
- •Engaged in meditation within the six months preceding the experiment.
- •Member of the research team or an immediate family member (defined as spouses, parents, children, or siblings, whether biological or legally adopted).
- •Currently taking psychoactive medications, including antidepressants, anxiolytics, hypnotics, or stimulants, or having used these medications in the past week.
- •History of major neurological or psychiatric disease within the past six months.
结局指标
主要结局
Self-reported Stress
时间窗: Participants will complete the STAI-6 assessment six times throughout the trial, once per day on Days 1 through 3. On each day, they will report their STAI-6 levels twice: once before listening to the audio track and once immediately after listening
We will measure self-reported acute stress using the State-Trait Anxiety Inventory - Short Form (STAI-6), a validated 6-item version of the 40-item State-Trait Anxiety Inventory developed by Marteau and Bekker. The STAI-6 assesses current (state) anxiety symptoms using a 4-point Likert scale ranging from 1 (Not at all) to 4 (Very much). Example items include "I feel calm" and "I am tense." For data analysis, the mean score of the 6 items was calculated. Therefore, scores range from 1 to 4, with higher scores indicating greater levels of acute stress (worse outcome). In the table, the averaged score for STAI-6 at pre/post assessments for each of the three days of the intervention is provided. Results for the two conditions are provided.
次要结局
- Physiological Stress(Participants will assess their HRV values seven times over the course of the trial (from Day 1 to Day 3). The first measurement will be a test, the first and second measurement each day will be taken before and after listening to the audio track.)
- Ecological Momentary Assessment - (EMA)(Participants will complete the Ecological Momentary Assessments (EMAs) six times throughout the trial, once per day on Days 1 through 3. On each day, they will report their EMAs levels twice: once before listening to the audio track and once immediately)
研究者
Alessandro Sparacio
Principal Investigator
Institute for Human Development and Potential (IHDP), Singapore