Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Mindfulness Intervention
Placebo
- Sleep Hygiene
What it measured
Main measures
Sleep Quality
4 months
Mood and sleep
Other measures (2)
Self-Reported Sleep Quality
4 months
Myelin repairMood and sleepSelf-Reported Quality of Life
4 months
FatigueBladder, bowel and sexual functionPainQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over · EDSS 0 to 7.0
Show the full 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
A pilot, randomized, placebo-controlled study of mindfulness meditation in treating insomnia in multiple sclerosis.BMC Neurol · 2023
Background
Viana P, Rodrigues E, Fernandes C, Matas A, Barreto R, Mendonca M, Peralta R, Geraldes R. InMS: Chronic insomnia disorder in multiple sclerosis - a Portuguese multicentre study on prevalence, subtypes, associated factors and impact on quality of life. Mult Scler Relat Disord. 2015 Sep;4(5):477-483. doi: 10.1016/j.msard.2015.07.010. Epub 2015 Jul 26.Background
Veauthier C, Radbruch H, Gaede G, Pfueller CF, Dorr J, Bellmann-Strobl J, Wernecke KD, Zipp F, Paul F, Sieb JP. Fatigue in multiple sclerosis is closely related to sleep disorders: a polysomnographic cross-sectional study. Mult Scler. 2011 May;17(5):613-22. doi: 10.1177/1352458510393772. Epub 2011 Jan 28.Background
Veauthier C, Paul F. Sleep disorders in multiple sclerosis and their relationship to fatigue. Sleep Med. 2014 Jan;15(1):5-14. doi: 10.1016/j.sleep.2013.08.791. Epub 2013 Nov 15.Background
Braley TJ, Segal BM, Chervin RD. Obstructive sleep apnea and fatigue in patients with multiple sclerosis. J Clin Sleep Med. 2014 Feb 15;10(2):155-62. doi: 10.5664/jcsm.3442.Background
Brass SD, Li CS, Auerbach S. The underdiagnosis of sleep disorders in patients with multiple sclerosis. J Clin Sleep Med. 2014 Sep 15;10(9):1025-31. doi: 10.5664/jcsm.4044.Background
Cartwright RD. Alcohol and NREM parasomnias: evidence versus opinions in the international classification of sleep disorders, 3rd edition. J Clin Sleep Med. 2014 Sep 15;10(9):1039-40. doi: 10.5664/jcsm.4050. No abstract available.Background
Merlino G, Fratticci L, Lenchig C, Valente M, Cargnelutti D, Picello M, Serafini A, Dolso P, Gigli GL. Prevalence of 'poor sleep' among patients with multiple sclerosis: an independent predictor of mental and physical status. Sleep Med. 2009 Jan;10(1):26-34. doi: 10.1016/j.sleep.2007.11.004. Epub 2008 Jan 22.Background
Stanton BR, Barnes F, Silber E. Sleep and fatigue in multiple sclerosis. Mult Scler. 2006 Aug;12(4):481-6. doi: 10.1191/135248506ms1320oa.Background
Boe Lunde HM, Aae TF, Indrevag W, Aarseth J, Bjorvatn B, Myhr KM, Bo L. Poor sleep in patients with multiple sclerosis. PLoS One. 2012;7(11):e49996. doi: 10.1371/journal.pone.0049996. Epub 2012 Nov 14.
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History
Started
Dec 2017
Main results due
Dec 2019
Finished
Dec 2019