A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Sleep Quality
研究概览
简要总结
Purpose To determine whether Mindfulness-Based Treatment for Insomnia (MBTI) is more effective in the treatment of chronic insomnia disorder (CID) in patients with multiple sclerosis (MS) when compared with standard sleep hygiene counseling.
Specific Aims / Hypotheses
Our specific aims are to determine:
- Whether MBTI is more effective than standard sleep hygiene counseling in improving objectively-measured sleep quality among this group of MS patients with CID, as measured by the Fitbit Charge 2 activity tracker.
- Whether MBTI is more effective than standard sleep hygiene counseling in improving self-reported sleep quality among this group of MS patients with CID, as measured by the Pittsburgh Sleep Quality Index (PSQI).
- Whether MTBI is more effective than standard sleep hygiene counseling in reducing self-reported severity of insomnia among this group of MS patients with CID, as measured by the Insomnia Severity Index (ISI).
- Whether MBTI is more effective than standard sleep hygiene counseling in improving self-reported quality of life among this group of MS patients with CID, as measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI).
We hypothesize that among study participants with MS and CID:
- MBTI will improve their objectively-measured sleep quality, as measured by the Fitbit Charge 2 activity tracker.
- MBTI will improve their self-reported sleep quality, as measured by the PSQI.
- MBTI will reduce their self-reported severity of insomnia, as measured by the ISI.
- Improvement in sleep quality and reduction in insomnia severity will result in improvement in self-reported quality of life, as measured by MSQLI scores.
- MBTI will be superior to sleep hygiene counseling in improving sleep quality, reducing insomnia severity, and improving quality of life.
详细描述
BACKGROUND:
An estimated 25 to 40 percent of individuals with multiple sclerosis (MS) suffer from chronic insomnia, and the prevalence of sleep disorders is often unrecognized. Chronic insomnia disorder (CID) is defined as persistent difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate opportunity and circumstances for sleep, leading to daytime impairment, and ongoing for at least three consecutive months.
Common causes of CID in MS include motor disorders such as cramps, spasms, restless leg syndrome and periodic limb movements, neuropathic pain, bladder dysfunction (such as nocturia), and obstructive sleep apnea. Depression, anxiety, daytime fatigue, and cognitive dysfunction are also associated with sleep disorders in MS. Moreover, treatments for the underlying disease, such as interferon therapy, as well as treatments for various symptoms of MS, such as stimulant medications used to treat fatigue, may also contribute to insomnia.
Many patients manage their insomnia using benzodiazepines and other medications, which may be associated with a number of adverse effects, including dependence and tolerance, cognitive dysfunction, and depression. Furthermore, other adverse effects of benzodiazepines arise from their use in combination with other drugs such as opioid narcotics for pain. Therefore, it is desirable to find effective nonpharmacological treatments for insomnia in patients with multiple sclerosis.
Psychologically-based and behavioral treatments have been widely tested in various cohorts of patients with CID with and without co-morbid conditions. These methods include cognitive behavioral therapies (CBT), sleep hygiene programs, mindfulness meditation, and others. In a randomized controlled clinical trial of 72 women with CID and MS in Iran, CBT treatment was associated with improved sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). A case series of 11 patients with chronic insomnia and MS who were treated with CBT at the Cleveland Clinic Sleep Disorders Center improved on measures of insomnia, fatigue and depression, as well as an increase in total sleep time of 1.5 hours.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women age 18 years or older
- •Diagnosis of multiple sclerosis per the 2014 Revised MacDonald criteria
- •Moderate to severe insomnia based on Insomnia Severity Index score
- •Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 7.0
- •Stable medications and disease activity for the past 30 days
- •Willingness to visit Griffin Hospital for up to 13 times if assigned to the mindfulness group, or up to 4 times if assigned to the sleep hygiene group, for study assessment and counseling or educational sessions
排除标准
- •Diagnosis of obstructive sleep apnea or narcolepsy
- •High risk of obstructive sleep apnea, as determined by the STOP-Bang questionnaire, if no known diagnosis of sleep apnea
- •Significant pulmonary, cardiac, hepatic or other medical conditions
- •Relapse of MS symptoms within the 30 days prior to study entry
- •Use of corticosteroids, either IV or oral, for exacerbations of symptoms
- •Inability to comply with the protocol
- •A lack of proficiency in reading, writing in, and understanding English
- •Body mass index (BMI) > 39 (350 lb. due to the limitations of the scale used for the study)
结局指标
主要结局
Sleep Quality
时间窗: 4 months
Objective sleep quality will be measured using a Fitbit Charge activity monitor to be worn daily during the 10-week intervention, and daily during a 4-month post-intervention period. For the purpose of assessing the impact of the intervention on objective sleep quality, the first week of Fitbit sleep data collected during the 10-week intervention (i.e., during the week of the mindfulness orientation session) will count as baseline data; the last week of the 10-week intervention will count as post-intervention data; and the last week of the 4-month post-intervention period will be used to assess the sustainability of the intervention. Data from the remaining weeks of the 10-week intervention and 4-month post-intervention periods will be used to examine whether participants experience an upward trend in sleep quality during the course of the study.
次要结局
- Self-Reported Sleep Quality(4 months)
- Self-Reported Quality of Life(4 months)
研究者
Joseph B. Guarnaccia
Director of the MS Treatment Center at Griffin Hospital
Griffin Hospital