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临床试验/NCT05608304
NCT05608304已完成不适用

The Effectiveness and Acceptability of Formal Versus Informal Mindfulness Among University Students With and Without Recent Nonsuicidal Self-injury: An Online, Parallel-group, Randomized Controlled Trial

McGill University1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2022年11月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
254
试验地点
1
主要终点
Change in state mindfulness (as measured by the VAS)

研究概览

简要总结

The present study will use a randomized controlled design to investigate group differences between students with and without a history of nonsuicidal self-injury (NSSI) in response to a single-session mindfulness induction across conditions (formal mindfulness induction, informal mindfulness induction, active control task) in terms of the intervention's acceptability and effectiveness. Effectiveness will be inferred via pre-post changes in state mindfulness, state stress, and state well-being.

详细描述

As university students have reported increasing levels of stress and difficulty coping with the challenges of university, student services have had to consider alternative approaches to meet the demand for student support. Thus, universities have moved beyond traditional mental health services to instructional, resilience-building approaches to enhance students' resilience and coping capacity. Mindfulness is a common foundation of these approaches due to the substantial evidence demonstrating the mental health and well-being benefits of mindfulness in university students. However, subgroups within the university student population may respond differently to standard mindfulness instruction.

Specifically, research suggests that university students who engage in non-suicidal self-injury (NSSI; the deliberate destruction of one's bodily tissue in the absence of lethal intent) may respond to mindfulness practice differently than students without such a history. Students with a history of NSSI are particularly prone to experiencing challenges in terms of stress, coping, and well-being in the university context. Thus, these students stand to benefit greatly from mindfulness-based programming that is adapted to their needs.

Standard mindfulness instruction generally consists of a combination of formal and informal practice. Formal practices can be conceptualized as structured, sustained attentional guided activities in which mindfulness is practiced within an allotted period of time (e.g., sitting meditation, body scan), whereas informal practices are brief and unstructured, and focus on the experience of one's senses during routine activities (e.g., becoming aware of the feeling of water on one's hands while washing them). Formal practice often requires sustained attention on one's inner experience (i.e., thoughts and emotions) and bodily sensations. Thus, existing difficulties with emotion regulation, self-criticism, and a potentially complex relationship with their body may render this common component of formal mindfulness practice sub-optimally effective among students with a history of NSSI.

By contrast, informal mindfulness strategies that are brief and unstructured may be more appropriate for these students. Nevertheless, only a few studies have attempted to parse out the benefits of formal and/or informal practice, and the results suggest benefits of informal mindfulness that are distinct from formal mindfulness. Furthermore, a recent systematic review examining the benefits of informal mindfulness concluded that informal practices may be more acceptable among those already experiencing difficulties with emotion regulation (e.g., those with recent NSSI engagement). The need for additional studies exploring the potentially differential acceptability and effectiveness of formal and informal mindfulness instruction among groups with unique intrapersonal needs was underscored.

Thus, the present study will use an online, parallel-group, randomized controlled design to investigate group differences between students with and without a history of NSSI in response to a single-session mindfulness induction across conditions (formal mindfulness induction, informal mindfulness induction, active control task) in terms of the intervention's acceptability and effectiveness. Effectiveness will be inferred via pre-post changes in state mindfulness, state stress, and state 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
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Current student at the host institution
  • •18-29 years old
  • •Either a history of engaging in NSSI on at least 5 separate days in the last year or no history of ever having engaged in NSSI

排除标准

  • •Having a history of NSSI that does not fulfill the recency/frequency requirement

研究组 & 干预措施

Formal mindfulness induction

Experimental

干预措施: Formal mindfulness induction (Behavioral)

Informal mindfulness induction

Experimental

干预措施: Informal mindfulness induction (Behavioral)

Active control task

Active Comparator

干预措施: Active control task (Behavioral)

结局指标

主要结局

Change in state mindfulness (as measured by the VAS)

时间窗: Pre-post intervention (10-minute interval)

A Visual Analogue Scale (VAS), an instrument commonly used in induction research (e.g., Hessler-Kaufmann et al., 2020), will also be used to assess the momentary experience of five mindfulness facets, as generally described by Baer et al. (2006). Specifically, there will be five researcher-developed VAS items (one for each facet of mindfulness), modelled on the items in the Five Facets of Mindfulness Questionnaire (FFMQ; Baer et al., 2006). Each VAS will consist of a small, unmarked ruler with anchors labeled as "0 = Not true at all" and "10 = Completely true." Instructions will read: "Please indicate the extent to which each statement below accurately reflects your experience in this moment on the corresponding ruler below by dragging the slider," for each of the five facets of mindfulness. Each scale will yield a single subjective state mindfulness facet score from 0 to 10, where a higher VAS score indicates greater state mindfulness (on that facet).

次要结局

  • Change in state mindfulness (as measured by the FFMQ-24)(Pre-post intervention (10-minute interval))
  • Change in state stress (as measured by the VAS)(Pre-post intervention (10-minute interval))
  • Change in state stress (as measured by the PSM-9)(Pre-post intervention (10-minute interval))
  • Change in well-being (as measured by the VAS)(Pre-post intervention (10-minute interval))
  • Acceptability (as measured by the TFA questionnaire)(Post-intervention only (5 minutes))
  • Acceptability (as measured by the IMI)(Post-intervention only (5 minutes))

研究者

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

Nancy Heath

Distinguished James McGill Professor

McGill University

研究点 (1)

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