跳至主要内容
临床试验/NCT04417153
NCT04417153Unknown不适用

Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes

National University of Singapore1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Change in subjective measures of Stress: Perceived Stress Scale (PSS)

研究概览

简要总结

Mindfulness training has been gaining popularity in the past decade as a means of improving general well-being. This trend appears in response to the new stressors that have arisen with the increased stress of the 21st century. Studies have shown that the psychological state of metacognitive awareness encapsulated in mindfulness can promote the decreasing of stress as well as the secondary effect of improving sleep quality; both outcome measures of this study. While the body of research evaluating these benefits is growing, there is limited emphasis placed on the individual differences that can affect the overall efficacy of mindfulness training.

Our aim in this study is to observe the effects of mindfulness training on perceived stress levels as well as on sleep using subjective measures in a large sample of trainees. To achieve this, participants will be recruited from a pool of people who have signed up for a 4-week foundational mindfulness or 8-week mindfulness based stress reduction course at Brahm Centre. Questionnaires will be administered both before and after these courses to evaluate both stress levels and sleep habits as well as other factors which could contribute to the efficacy of mindfulness training. These inventories will probe the different facets of interpersonal differences that could serve to influence the effectiveness of the mindfulness intervention. In addition, the investigators will also test the effect of conducting the course online during a situation of emergency, like it is the partial lockdown that was implemented in Singapore due to the spread of Covid-19.

The proposed study has the potential to provide new insights into the factors that affect the efficacy of mindfulness on stress and sleep, in a situation of non-emergency (until February the 6th 2020) as well as during a period of heightened restrictions (DORSCON Orange, from 7th of February to 6th of April 2020) and a partial lockdown (from 7th of April to 1st of June 2020, or until resume of normal activity). Further, the investigators hope to build an algorithm that can predict the potential effectiveness of mindfulness on a person by person basis. This could serve as a foundation for future recommendations for mindfulness training as well as open the door for future studies that could serve to further customize the mindfulness training framework to accommodate individual differences

详细描述

Health and well-being are increasingly being emphasized in modern society. In response, mindfulness-based training (MBT) (e.g. Mindfulness Based Stress Reduction (MBSR) (Kabat-Zinn,1990)) is slowly gaining popularity as a method to alleviate the stress of modern day living. MBT involves bringing one's attention to the present moment, stopping one's thoughts from drifting into concerns about the past or the future It has significant effects on improving mental health via reducing symptoms of stress, anxiety and depression (Fjorback, Arendt, Ørnbøl, Fink & Walach, 2019). Local studies have similarly demonstrated the efficacy of mindful training in stress reduction for mental health professionals in Singapore (Suyi, Meredith & Khan, 2017).

Reducing stress and improving metacognitive processes also contributes to better emotional regulation, thus facilitating better sleep quality (Chiesa et al., 2011; Zeidan et al., 2010).. By breaking up cycles of rumination and worry, mindfulness is hypothesized to reduce "verbal overregulation" and facilitate the disengagement necessary to fall asleep (Gross et al., 2011). Mindfulness programs have been found to improve sleep quality in both healthy individuals (Lazar et al., 2000) and patients with medical or psychiatric illness, including insomnia and depression (Carlson & Garland, 2005; Heidenreich et al., 2006).

While there is much documentation supporting the efficacy of mindfulness training on stress and sleep, there is little research that attempts to evaluate the interpersonal differences or factors that predict the efficacy of mindfulness training on sleep and stress. Isolating these predictive variables consequently allows a better way to evaluate suitability of the mindfulness intervention on an individual basis; maximizing the results for the individual. With this new information, individuals suffering from stress and bad sleep would be able to better be able to select the most effective intervention.

While the concepts above have often been explored in relation to mindfulness, no studies to date have used machine learning to assess how these variables predispose an individual to benefit from mindfulness training. Generating this algorithm will allow for the prediction of treatment response in future trainees. Further, a better understanding of the effect of individual differences on efficacy can open the door for future research to examine how and why these differing results exist and incorporate this information to increase the effectiveness of mindfulness training.

Participants signing up for the 4 or 8 weeks mindfulness training courses at the Brahm Centre and run by Potential Project (two external organization providing Mindfulness based courses) will be automatically sent a link to the questionnaire packet several days after course enrolment. Participants will be provided with a survey link in the enrolment email that is sent to participants to confirm their enrolment, separate recruitment e-mails will not be sent out.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •Any individual above 21 years old enrolled in Mindfulness-Based Stress Reduction/Mindfulness Foundation course at Brahm Centre or with a mindfulness course with Potential Project can be included in the study.

排除标准

  • •no exclusion criteria

结局指标

主要结局

Change in subjective measures of Stress: Perceived Stress Scale (PSS)

时间窗: Up to one month

The PSS measures whether different aspects of life were perceived as stressful by participants on a 5-point scale (where 0 was never and 4 was very often) in the past month. Positively worded questions are reversed scored and all 10 questions ratings are summarised into a total score, which ranges from 0 to 40, with higher scores indicating more perceived stress.

Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index total Score

时间窗: Up to one month

Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score above 5 suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep quality

次要结局

  • Change in Subjective Time in Bed (TIB)(Up to one month)
  • Change in Subjective Sleep Onset Latency (SOL)(Up to one month)
  • Change in Subjective Total Sleep Time (TST)(Up to one month)
  • Change in Subjective Wake After Sleep Onset (WASO)(Up to one month)

研究者

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

Julian Lim

Assistant Professor

National University of Singapore

研究点 (1)

Loading locations...

相似试验