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临床试验/NCT06785259
NCT06785259尚未招募不适用

Complex Systems Analysis of the Impact of Mindfulness Intervention on Emotional Distress: A Study of Daily Interventions and Daily Diary

Peking University0 个研究点目标入组 120 人开始时间: 2025年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Daily changes of mindfulness

研究概览

简要总结

This study hopes to explore whether the changes in rumination exhibited in Daily Diary mediates the effects of mindfulness intervention on alleviating emotional distress

详细描述

This study will employ a daily diary research design to collect detailed time-series data, capturing the dynamic evolution of participants' emotional changes. This approach not only facilitates the provision of robust evidence regarding the effects of mindfulness interventions but also offers valuable insights for refining and personalizing future intervention strategies.

Mindfulness involves observing one's current state of mind with an open, non-judgmental attitude, including awareness of breathing, bodily sensations, and actions (Wielgosz et al., 2019). With the widespread use of the internet and smartphones, there has been a rapid increase in the demand for mental health services, leading to the emergence of lightweight online mindfulness intervention programs that have garnered increasing attention (Taylor et al., 2021).

Mindfulness-based interventions (MBIs) can positively impact various aspects of individuals' lives (Wielgosz et al., 2019), including physical and mental health, cognitive abilities, emotions, and interpersonal relationships. Regular mindfulness training often leads to healthier behaviors, such as reduced substance abuse, decreased self-harm and suicidal behaviors, and alleviation of eating disorder symptoms (Schuman-Olivier et al., 2020). MBIs are applicable to both clinical and non-clinical populations: they benefit not only patients with physical or mental illnesses (Carlson, 2012; Turgon et al., 2019) but also those experiencing behavioral or emotional distress (Ju, 2022; Ma et al., 2018).

In addition to studying the efficacy of interventions, it is crucial to explore their mechanisms of action. Traditional methods of mechanism research have provided some evidence, defining mechanisms as "processes responsible for change," while mediators are "statistical explanations of the relationship between independent and dependent variables" (Kazdin, 2007, p.3). Currently, researchers have begun to investigate the mechanisms underlying mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) (Batink et al., 2013; Geschwind et al., 2011; Alsubaie et al., 2017).

However, traditional theoretical frameworks and analytical methods cannot adequately explain or capture sudden, nonlinear changes during the intervention process. Such phenomena can be better understood through complex systems theory. By applying complex network theory and methods, we can gain new insights into the complexity and dynamics of changes during the intervention process, identify intervention targets, uncover potential core targets, predict abrupt changes, and provide evidence for optimizing intervention targets and timing, thereby enhancing the effectiveness of intervention programs. Complex systems theory holds great promise for understanding the mechanisms of psychological interventions, yet few studies have examined the complex and dynamic changes in psychological variables during interventions from this perspective in the field of mindfulness research.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

排除标准

  • •Subjects who could not access the Internet.
  • •Subjects with insufficient Chinese ability.
  • •Subjects who have participated in mindfulness-based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week.
  • •Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder.
  • •Subjects at risk of suicide.

研究组 & 干预措施

MIED group

Experimental

Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces the nature and law of anxiety, depression, and other emotions, the source of anxiety, depression, and other emotional distress, and the strategies and methods to alleviate emotional distress. These exercises, knowledge, and strategies are based on the latest progress in the field of psychological counseling and treatment, and their application in daily life can help alleviate anxiety, depression, and other emotional problems.

干预措施: Mindfulness Intervention for Emotional Distress(MIED) (Behavioral)

结局指标

主要结局

Daily changes of mindfulness

时间窗: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

The Daily Mindfulness Response Scale measures the frequency with which one returns to a nonjudgmental and unconditionally receptive present moment awareness during the day. Each item is rated on a scale ranging from 1 (rarely)to10(often). scores range from 4 to 40, with higher scores indicating higher levels of mindful responding

Daily changes of rumination

时间窗: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

measured by Momentary repetitive negative thinking, night items, scores range from 9 to 63, with higher scores indicating higher levels of reprtitive negative thinking.

Daily changes of positive and negative affect

时间窗: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

Daily positive and negative affect were measured using the 10-itemInternational Positive and Negative Affect Schedule-Short Form Scale. Scores range from 5 to 25, with higher scores indicating higher levels of positive/negative affect.

Daily changes of emotional distress

时间窗: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

The 10-item Kessler Psychological Distress Scale is a self-reported questionnaire measuring distress. Scores range from 10 to 50, with higher scores indicating higher levels of distress.

daily changes of anxiety

时间窗: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

daily changes of depression

时间窗: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.

Daily changes of the Brief State Rumination Inventory

时间窗: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

he Brief State Rumination Inventory comprises eight items designed to measure an individual's state rumination tendency at a given moment, encompassing aspects such as the intensity of negative emotions, repetitive thinking, loss of thought control, and the strength of negative affect. The total score, which is derived by summing up the scores of all items, indicates the overall level of the measured construct.

次要结局

未报告次要终点

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinghua Liu

Director

Peking University

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