Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
Клучни зборови
Апстракт
Опис
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.
Mindfulness based stress reduction (MBSR) is an empirically-supported intervention designed to decrease stress, chronic and acute pain and anxiety in adults. Mindfulness is the practice of focusing full attention on the present moment intentionally and without judgment. The practice of mindfulness is hypothesized to reduce feelings of distress and stress reactivity by increasing one's awareness of and ability to tolerate thoughts and emotions. Mindfulness may help individuals decrease distress and over-reactivity to events and increase the ability to respond to events in ways that one consciously chooses (rather than through automatic 'mindless" behaviors). Mindfulness-based interventions such as MBSR teach mindfulness through meditation, yoga, present-minded awareness in everyday life, and discussions of stress physiology and coping.
Several studies have demonstrated the effectiveness of MBSR interventions in the treatment of insomnia. Long-term meditators have been shown to have increased parietal-occipital gamma (25-40 Hz) during NREM (non-rapid eye movement sleep), showing that MBSR can induce objective changes in sleep architecture. MBSR and MBTI (mindfulness based treatment of insomnia) have been shown in randomized, controlled studies to decrease sleep latency and total waking time and increase sleep time.These effects, moreover, have been durable. However, a meta-analysis of 6 randomized controlled trials involving 330 participants showed that mindfulness meditation significantly improved total wake time and sleep quality, but had no significant effects on sleep onset latency, total sleep time, wake after sleep onset, sleep efficiency, total wake time, Insomnia Severity Index (ISI), PSQI, or Dysfunctional Beliefs and Attitudes Sleep Scale (DBAS).
Mindfulness training has been shown to be beneficial in improving several symptoms of MS, including those that have been shown to impact sleep. A randomized, controlled study of 150 patients undergoing mindfulness training showed improvements in quality of life and well-being, including fatigue and depression. Furthermore, there is Class 1 evidence that stress reduction in MS can affect the underlying inflammatory biology of MS, as evidenced by a reduction in new MRI lesions. However, many other studies showing benefits of stress reduction in MS are limited by their descriptive nature and non-controlled design.
The significance of this study is that while there are data showing the effectiveness of mindfulness-based techniques in treating insomnia in general, and some data showing the benefits of using non-mindfulness stress reduction techniques in the management of MS-related insomnia, there have been no studies to date on the efficacy of mindfulness techniques in treating MS-related insomnia.
Датуми
| Последен пат проверено: | 01/31/2020 |
| Прво доставено: | 12/28/2018 |
| Поднесено е проценето запишување: | 05/12/2019 |
| Прво објавено: | 05/13/2019 |
| Последното ажурирање е доставено: | 02/24/2020 |
| Последно ажурирање објавено: | 02/25/2020 |
| Крај на датумот на започнување на студијата: | 12/10/2017 |
| Проценет датум на примарно завршување: | 12/15/2019 |
| Проценет датум на завршување на студијата: | 12/15/2019 |
Состојба или болест
Интервенција / третман
Behavioral: Mindfulness Intervention
Behavioral: Sleep Hygiene
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Active Comparator: Mindfulness Intervention Mindfulness-Based Treatment for Insomnia intervention led by a certified instructor. It is adapted from the Mindfulness-Based Stress Reduction Curriculum developed by the Center for Mindfulness in Medicine, Health Care, and Society at the University of Massachusetts Medical School. It introduces the concept of mindfulness and provides the opportunity to practice it within sessions and during home practice. Participants learn about stress, and explore habitual behavioral, physical, emotional and cognitive patterns, as well as more effective responses to challenges and demands of everyday life. Each class includes mindfulness practice, group discussions, and practices and exercises related to the class topics. Participants receive home assignments with guided meditation and yoga practices. | Behavioral: Mindfulness Intervention 10-session program
Introduction to mindfulness and its potential benefits
Introduction to mindful practices and yoga poses
Conditioned reactions to stress; integrating mindfulness into everyday life
Challenges and insights gained in practicing mindfulness
Using mindfulness to observe and reduce negative means of reacting to stress, and find more effective responses
Reacting vs. responding to stressors
Self-regulation and coping with stressors and communication challenges
Fostering continuity of moment-to-moment awareness while practicing different forms of mindfulness
Choosing and creating one's own blend of mindfulness practices
Maintaining momentum to practice mindfulness once the program ends |
| Placebo Comparator: Sleep Hygiene Control group participants attend a 30-minute group counseling session on sleep hygiene. The session includes a handout from the Centre for Clinical Intervention in Australia that provides 15 sleep hygiene tips. | Behavioral: Sleep Hygiene Session includes a handout with15 sleep hygiene tips:
Maintain a regular sleep pattern
Only try to sleep when feeling tired or sleepy
If unable to sleep, do something calm until feeling tired and returning to bed
Avoid caffeine & nicotine for 4-6 hours before going to bed
Avoid alcohol for 4-6 hours before going to bed
Use the bed only for sleeping and sex
Avoid naps during the day
Develop rituals to get relaxed and ready to sleep
Try a hot bath prior to bedtime
Avoid checking the clock during the night
Use a sleep diary for a few weeks to track progress
Avoid strenuous exercise before bedtime
Avoid a heavy meal before bedtime
Create a sleep environment that is quiet, comfortable, and dark
Maintain a regular daytime routine |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | Inclusion Criteria: 1. Men and women age 18 years or older 2. Diagnosis of multiple sclerosis per the 2014 Revised MacDonald criteria 3. Moderate to severe insomnia based on Insomnia Severity Index score 4. Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 7.0 5. Stable medications and disease activity for the past 30 days 6. 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 Exclusion Criteria: 1. Diagnosis of obstructive sleep apnea or narcolepsy 2. High risk of obstructive sleep apnea, as determined by the STOP-Bang questionnaire, if no known diagnosis of sleep apnea 3. Significant pulmonary, cardiac, hepatic or other medical conditions 4. Relapse of MS symptoms within the 30 days prior to study entry 5. Use of corticosteroids, either IV or oral, for exacerbations of symptoms 6. Inability to comply with the protocol 7. A lack of proficiency in reading, writing in, and understanding English 8. Body mass index (BMI) > 39 (350 lb. due to the limitations of the scale used for the study) |
Исход
Мерки на примарниот исход
1. Sleep Quality [4 months]
Секундарни мерки на исходот
1. Self-Reported Sleep Quality [4 months]
2. Self-Reported Quality of Life [4 months]
Други мерки на исход
1. Adverse Events [4 months]
2. Progression of MS [4 months]
3. Muscle Spasticity [4 months]
4. Restless Leg [4 months]
5. Medication and Supplements [4 months]
