A Randomized Controlled Study Comparing the Effect of Preferential and Random Allocation to Type of Mindfulness Practice in the General Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Change from baseline (T0) to post-intervention (T2) on the Toronto Mindfulness Scale, State Version (TMS-SV; Lau et al., 2006).
研究概览
简要总结
The goal of this randomized controlled study is to examine whether allocation based on preference to one of two brief mindfulness meditation practices (mindfulness of the breath or mindfulness of sounds) influences the potentially beneficial effects of these practices, and influences participants' intention to engage in further mindfulness practice. To the end, members of the general public will be randomly assigned to one of three groups: (1) a group in which they choose which of the two mindfulness practices they do; (2) a group in which they are randomly allocated to do one of the mindfulness practices; and (3) a control group that listens to an audiobook extract. The level of mindfulness of each group will be compared, along with some other outcomes.
详细描述
The study will be an online administered experimental 3x2x3 design, with between-participant factor group (allocated to mindfulness practice based on preference vs. randomly allocated to mindfulness practice vs. audiobook control); a between-participant factor of practice type (mindfulness of the breath vs. mindfulness of sounds), which will be a dummy variable for the control group; and a within-participant factor of time (baseline vs. post-allocation vs. post-intervention). Participants in the 'preference group' will choose which of two mindfulness meditation practices (mindfulness of the breath or mindfulness of sounds) to undertake based on a brief description. Participants in the 'random allocation' group will be allocated to one of the two mindfulness practices at random, and participants in the control group will listen to an excerpt from an audiobook of an equivalent length of time. The primary outcome, state mindfulness, will be measured at all three time-points, as will positive and negative mood. Practice quality and intentional to engage in future mindfulness practice will be measured at post-intervention only.
The following hypotheses will be tested:
H1: Both the allocation by preference and random allocation groups will show greater improvement than the control group on both the primary outcome (baseline to post-intervention change in state mindfulness) and all the secondary outcomes, with the exception of practice quality (which is not applicable for the control group).
H2: The allocation by preference group will show better primary and secondary outcomes than the allocation by random group.
H3: The difference between each mindfulness-practice group and the control group in baseline to post-intervention improvement in mood state will be statistically mediated by baseline to post-intervention increase in state mindfulness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome measures will be collected online using Qualtrics without involvement of a researcher.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident in the UK
排除标准
- •Currently practicing mindfulness meditation more than once per week.
- •Experiencing significant mental health problems.
- •Believe that practicing mindfulness could cause significant distress.
- •Previously practicing mindfulness has caused significant distress.
研究组 & 干预措施
Allocation by preference
Participants are allocated to the one of the two mindfulness practices that they would prefer to do, based on a short description.
干预措施: Mindfulness of the breath (Behavioral)
Allocation by preference
Participants are allocated to the one of the two mindfulness practices that they would prefer to do, based on a short description.
干预措施: Mindfulness of sounds (Behavioral)
Allocation by random
Participants are randomly allocated to one of the two mindfulness practices.
干预措施: Mindfulness of the breath (Behavioral)
Allocation by random
Participants are randomly allocated to one of the two mindfulness practices.
干预措施: Mindfulness of sounds (Behavioral)
Control
Participants listen to an excerpt from an audiobook for an equivalent length of time to the mindfulness practices.
干预措施: Audiobook control (Behavioral)
结局指标
主要结局
Change from baseline (T0) to post-intervention (T2) on the Toronto Mindfulness Scale, State Version (TMS-SV; Lau et al., 2006).
时间窗: Post-intervention (T2; estimated to be on average 20 minutes after baseline)
The TMS-SV measures two facets of state mindfulness, namely curiosity (on a 0 to 24 scale) and decentering (on a 0 to 28 scale), with higher scores indicating greater state mindfulness.
次要结局
- Change from baseline (T0) to post-allocation (T1) on the Toronto Mindfulness Scale, State Version (TMS-SV; Lau et al., 2006).(Post-allocation (T1; estimated to be on average 5 minutes after baseline))
- Change from baseline (T0) to post-allocation (T1) on the Positive and Negative Affect Schedule - Postive Affect subscale (PANAS-P; Watson et al., 1988)(Post-allocation (T1; estimated to be on average 5 minutes after baseline))
- Practice Quality-Mindfulness (PQ-M; Del Re et al., 2022) at post-intervention (T2), for the mindfulness practice groups only.(Post-intervention (T2; estimated to be on average 20 minutes after baseline))
- Intention to practice mindfulness in future.(Post-intervention (T2; estimated to be on average 20 minutes after baseline))
- Change from baseline (T0) to post-allocation (T1) on the Positive and Negative Affect Schedule - Negative Affect subscale (PANAS-N; Watson et al., 1988)(Post-allocation (T1; estimated to be on average 5 minutes after baseline))
- Change from baseline (T0) to post-intervention (T2) on the Positive and Negative Affect Schedule - Postive Affect subscale (PANAS-P; Watson et al., 1988)(Post-intervention (T2; estimated to be on average 20 minutes after baseline))
- Change from baseline (T0) to post-intervention (T2) on the Positive and Negative Affect Schedule - Negative Affect subscale (PANAS-N; Watson et al., 1988)(Post-allocation (T2; estimated to be on average 20 minutes after baseline))