A Trial of Mindfulness Meditation for Chronic Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Insomnia Severity (Insomnia Severity Index)
研究概览
简要总结
To evaluate the efficacy of mediation therapies on measures of sleep and arousal for people with chronic insomnia and with this the viability of smartphone delivered meditation based approaches at a population level.
详细描述
Sleep complaints are amongst the commonest in medical practice, and insomnia, the commonest of these affecting transiently 1/3 of the population at some point in the year and 1/3 of this population that is 1 in 10 persisting as chronic insomnia. There are significant consequences on the quality of life for individuals and significant economic burden for society.
Insomnia disorder is characterized as persistent difficulty in falling or staying asleep with resulting daytime dysfunction. Once physical and psychiatric causes have been excluded, current treatment guidelines include pharmacological and behavioural approaches. Hypnotic therapy will reduce sleep latency and increase total sleep time, but there are concerns about drug dependency and side effects (residual day time sleepiness and road traffic accidents and impaired balance). Behavioural treatment (CBTi) has been shown to be effective, but availability is scarce and less than 50% of patients achieve full remission, making alternative approaches desirable.
To optimize availability and to improve outcomes, approaches have included group sessions, single treatment sessions and internet sessions, but these are still limited in the NHS by availability of resources or by expense. Mindfulness meditation, focused non-judgmental awareness and attention on the present moment experience, can promote calmness and relaxation. Several health benefits have been shown across stress related conditions, including sleep disturbance, and its universal availability and ease of application make it an attractive alternative to conventional CBTi.
A randomized controlled trial compared Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Therapy for Insomnia (MBTI), and Self-monitoring (SM) in the treatment of chronic insomnia . Results indicate that those receiving mindfulness-based interventions (MBSR or MBTI) had significant reductions in total wake time and pre-sleep arousal from baseline-to-post compared to SM. The study concluded that mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia.
A recent meta-analysis of 6 randomised controlled trials demonstrated that mindfulness meditation may contribute to improving sleep in subjects with insomnia compared to a control group. Specifically, mindfulness meditation was found to significantly reduce total wake time, sleep onset latency and sleep quality .
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18
- •Meet the diagnostic criteria for an insomnia disorder. Defined as difficulty initiating or maintaining sleep despite adequate opportunity, with at least one symptom of an associated daytime impairment. Additional quantitative insomnia criteria following research recommendations include frequency (defined as sleep onset latency (SOL) or wake after sleep onset (WASO) > 30 minutes at least 3 nights per week and for chronicity, defined as symptoms lasting > 6 months.
- •Have access to an iOS or Android smartphone or a desktop computer with Internet access
- •Participants will be required to sign an informed consent form
排除标准
- •Uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study
- •Uncontrolled psychiatric conditions requiring immediate treatment outside of the study, including current major depressive episode
- •Comorbid sleep disorders including obstructive sleep apnea
- •Current use of hypnotic or sedating medications for the purpose of insomnia
- •Inadequate proficiency in English to complete the protocol
- •Participation in other trials concurrently
- •Regular meditation practice defined as equal to or more than 2x weekly for the past 30 days
结局指标
主要结局
Change in Insomnia Severity (Insomnia Severity Index)
时间窗: 8 weeks, 3 and 6 month follow-up
Insomnia Severity Index (ISI): The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. This will be administered at baseline, after 8-weeks and at a 3 and 6-month follow-up. The index will be sent to by post and. It will take approximately 5 minutes to complete.
Change in Actigraphy determined wake time (TWT)
时间窗: 2-week screening, 8-week intervention, 3 and 6-month follow-up
Actigraphy: Sleep onset latency (SOL) and wake after sleep onset (WASO) will be determined using wrist actigraphy. Participants will be provided with an actiwatch during the screening interview conducted at the beginning of the study. The actiwatch will be worn on the non-dominant arm 24 hours a day, except for while bathing, during the 2-week screening period. Additionally, the actiwatch will be worn for one week after the 8-week intervention and for one week prior to the 3 and 6-month follow-up. Participants will send the actiwatch to the investigator by post after each measurement period. The actiwatch will be sent to participants by post before the next measurement point; apart from the first time point where the participant will be given the actiwatch.
次要结局
- Review of mobile-based mindfulness meditation application for insomnia(6 months)
- Mindfulness (CAMS-R)(Baseline, 8-weeks, 3 and 6-month follow-up)