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临床试验/NCT05676658
NCT05676658已完成不适用

Effects of Coherent Breathing Breathwork on Mental Health and Wellbeing: A Randomised Placebo-controlled Study

University of Sussex1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Subjective stress

研究概览

简要总结

The investigators are conducting a randomised-controlled trial comparing coherent breathing at ~5.5 breath cycles per minute-bcpm (with equal inhalation/exhalation durations of ~5.5secs each) to a well-designed placebo (paced breathing at 12bcpm with equal inhalation/exhalation durations of 2.5secs each). The metric of 12bcpm is in line with guidance from the British Journal of Nursing, Royal College of Physicians, and Johns Hopkins University which state that the average, healthy bcpm should range from: 12-20bcpm, 12-18bcpm, and 12-16bcpm, respectively, hence the investigators chose the minimum/lower bound for the active placebo control group. The main questions that our study attempts to address are: Does coherent breathing (and placebo coherent breathing) lead to improved mental health and wellbeing in a general population adult sample?

The study will be conducted entirely online through the research platform Prolific, so participant data will be anonymous. The investigators will collect self-reports of mental health and wellbeing before and after the four-week breathwork period, along with a follow-up one-month later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Participants will also be asked how many times they practiced out of the assigned 28 days, to gauge self-reported adherence to the protocol. The investigators can then observe whether self-reported adherence correlates with changes in mental health and wellbeing, if any. Data on the self-reported credibility/expectancy of the breathwork randomly allocated to participants will also be collected, along with open-ended responses on participants' overall experience of the protocol/study.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Subjective stress

时间窗: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention). Primary timepoint is post-intervention

Depression Anxiety Stress Scale-21 (DASS-21) - stress subscale (score range: 0-21; higher scores denote worse outcome). Score on DASS-21 is then multiplied by two to convert it to the longer form DASS-42 final score

次要结局

  • Self-reported credibility and expectancy of protocol(Immediately after starting breathwork intervention)
  • Subjective anxiety(Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention))
  • Subjective depressive symptoms(Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention))
  • Subjective wellbeing(Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention))
  • Self-reported adherence to protocol(Post-intervention (immediately after the intervention))
  • Subjective sleep disturbance(Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and four weeks after the intervention))

研究者

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

Guy Fincham

Guy William Fincham

University of Sussex

研究点 (1)

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