Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT03949296
• Recruitment Status: Completed
• First Posted: May 14, 2019
• Last Update Posted: February 26, 2020
• Sponsor: Griffin Hospital
• Collaborators: Yale-Griffin Prevention Research Center; Yale University- Stress Center
• Information provided by (Responsible Party): Joseph B. Guarnaccia, Griffin Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Insomnia Chronic; Multiple Sclerosis	Behavioral: Mindfulness Intervention; Behavioral: Sleep Hygiene	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A placebo-controlled, randomized, single-blinded clinical study involving a projected 90 participants with multiple sclerosis in a 50:50 randomization scheme.
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
• Actual Study Start Date: December 11, 2017
• Actual Primary Completion Date: December 16, 2019
• Actual Study Completion Date: December 16, 2019

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Sleep Quality [ Time Frame: 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.

Secondary Outcome Measures :

1. Self-Reported Sleep Quality [ Time Frame: 4 months ]
   Self-reported sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline, at the end of the 10-week intervention, and at 4 months post-intervention. The PSQI is a self-rated questionnaire to assess perceived sleep quality and disturbances over a 1-month time interval. This 19-item instrument uses a Likert scale (ranging from 0 to 3) to assess 7 clinically derived domains of sleep: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields one global score. Clinical and clinimetric properties of the PSQI were assessed over an 18-month period with "good" vs. "poor" sleepers. A global score > 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p < 0.001) in distinguishing good vs. poor sleepers.
2. Self-Reported Quality of Life [ Time Frame: 4 months ]
   Self-reported quality of life will be measured at baseline, the end of the 10-week intervention, and 4 months post-intervention using the Multiple Sclerosis Quality of Life Index (MSQLI). The MSQLI includes a set of 10 questionnaires to provide a quality of life measure that is both generic and MS-specific. The questionnaires assess health status, fatigue, pain, sexual satisfaction, bladder control, bowel control, visual impairment, perceived deficits, mental health, and social support. Each individual scale generates a separate score. There is no global composite combining all the scales into a single score. There is good internal consistency reliability for the subscales of the MSQLI, with the lowest alpha being 0.67 (for social functioning on SF-36). Other coefficients range from 0.78 (BWCS) to 0.97 (MSSS). Test-retest reliability on the SF-36 ranges from 0.60 (social functioning) to 0.81 (physical functioning).

Other Outcome Measures:

1. Adverse Events [ Time Frame: 4 months ]
   Any adverse events, including relapse of MS, experienced by study participants will be noted at the end of the 10-week intervention, and at 4-months post-intervention. In addition, if participants report any adverse events by contacting the research staff and/or study PI at any other time points during the study, these will be noted as well. The study team will address the handling of adverse events on a case-by-case basis.
2. Progression of MS [ Time Frame: 4 months ]
   Progression of MS will be measured by administering the Kurtzke Expanded Disability Status Scale (EDSS) at baseline (clinical screening), the end of the 10-week intervention, and 4 months post-intervention. The EDSS is a method of quantifying the degree of neurologic impairment in MS patients. It quantifies disability in 8 Functional Systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and "other"), and allows neurologists or other trained examiners to assign a Functional System Score (FSS) in each FS. Each FSS is an ordinal clinical rating scale ranging from 0 to 5 or 6. The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
3. Muscle Spasticity [ Time Frame: 4 months ]
   Since muscle spasticity is a frequent cause of insomnia in MS patients, the Modified Ashworth Scale (MAS) will be used to characterize the degree of spasticity at baseline (clinical screening), the end of the 10-week intervention and 4 months post-intervention among members of our study population. The MAS is a clinician-administered measure of muscle spasticity in patients with MS or other conditions such as stroke or spinal cord injury. It involves a subjective clinical assessment, without the use of specialized equipment, of muscle resistance to passive range of motion (ROM) about a single joint, while a patient is in a supine position. It uses a nominal scale ranging from 0 (no resistance) to 4 (rigidity), with a 1+ scoring category added to indicate resistance through less than half of the movement.
4. Restless Leg [ Time Frame: 4 months ]
   Since restless leg syndrome can impact insomnia in MS patients, self-reported restless legs syndrome severity will be measured using the International Restless Legs Scale (IRLS) at baseline, at the end of the 10-week intervention, and 4 months post-intervention to characterize the extent of this condition in our study population. The IRLS was developed by the International RLS Study Group to measure perceived severity of restless legs syndrome in the past week prior to administration. It includes 10 questions addressing respondents' perceptions of RLS-related discomfort, need to move around, relief from moving around, severity of sleep disturbance and tiredness from RLS symptoms, severity of RLS as a whole, frequency and severity of symptoms, severity of impact on daily living, and severity of mood disturbance. Response options are based on a 5-point scale ranging from 0 to 4, with 4 being very severe.
5. Medication and Supplements [ Time Frame: 4 months ]
   A list of medications and/or supplements used will be collected at baseline, the end of the 10-week intervention, and 4-months post-intervention to track changes in use of medication or supplements during the course of the study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, Connecticut

Yale-Griffin Prevention Research Center

Derby, Connecticut, United States, 06418

Sponsors and Collaborators

Griffin Hospital

Yale-Griffin Prevention Research Center

Yale University- Stress Center

Investigators

• Principal Investigator: Joseph B Guarnaccia, MD; Griffin Hospital

More Information

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• Responsible Party: Joseph B. Guarnaccia, Director of the MS Treatment Center at Griffin Hospital, Griffin Hospital
• ClinicalTrials.gov Identifier: NCT03949296
• Other Study ID Numbers: 2017-01
• First Posted: May 14, 2019
• Last Update Posted: February 26, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders