Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

NCT03949296 | Completed

• 1 other identifier: 2017-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  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.

  4 months

Secondary Outcomes (2)

• Self-Reported Sleep Quality

  4 months

• Self-Reported Quality of Life

  4 months

Other Outcomes (5)

• Adverse Events

  4 months

• Progression of MS

  4 months

• Muscle Spasticity

  4 months

Study Arms (2)

Mindfulness Intervention

ACTIVE COMPARATOR

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

Sleep Hygiene

PLACEBO COMPARATOR

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

Interventions

Mindfulness Intervention BEHAVIORAL

10-session program 1. Introduction to mindfulness and its potential benefits 2. Introduction to mindful practices and yoga poses 3. Conditioned reactions to stress; integrating mindfulness into everyday life 4. Challenges and insights gained in practicing mindfulness 5. Using mindfulness to observe and reduce negative means of reacting to stress, and find more effective responses 6. Reacting vs. responding to stressors 7. Self-regulation and coping with stressors and communication challenges 8. Fostering continuity of moment-to-moment awareness while practicing different forms of mindfulness 9. Choosing and creating one's own blend of mindfulness practices 10. Maintaining momentum to practice mindfulness once the program ends

Mindfulness Intervention

Sleep Hygiene BEHAVIORAL

Session includes a handout with15 sleep hygiene tips: 1. Maintain a regular sleep pattern 2. Only try to sleep when feeling tired or sleepy 3. If unable to sleep, do something calm until feeling tired and returning to bed 4. Avoid caffeine \& nicotine for 4-6 hours before going to bed 5. Avoid alcohol for 4-6 hours before going to bed 6. Use the bed only for sleeping and sex 7. Avoid naps during the day 8. Develop rituals to get relaxed and ready to sleep 9. Try a hot bath prior to bedtime 10. Avoid checking the clock during the night 11. Use a sleep diary for a few weeks to track progress 12. Avoid strenuous exercise before bedtime 13. Avoid a heavy meal before bedtime 14. Create a sleep environment that is quiet, comfortable, and dark 15. Maintain a regular daytime routine

Sleep Hygiene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Griffin Hospital: lead
• Yale-Griffin Prevention Research Center: collaborator
• Yale University- Stress Center: collaborator

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

Related Publications (47)

• 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.

  PMID: 26346798 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.

  PMID: 21278050 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.

  PMID: 24360534 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.

  PMID: 24532998 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.

  PMID: 25142763 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.

  PMID: 25221449 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.

  PMID: 18207453 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.

  PMID: 16900762 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.

  PMID: 23166808 BACKGROUND

• Bamer AM, Johnson KL, Amtmann DA, Kraft GH. Beyond fatigue: Assessing variables associated with sleep problems and use of sleep medications in multiple sclerosis. Clin Epidemiol. 2010 May 1;2010(2):99-106. doi: 10.2147/CLEP.S10425.

  PMID: 20838467 BACKGROUND

• Italian REMS Study Group; Manconi M, Ferini-Strambi L, Filippi M, Bonanni E, Iudice A, Murri L, Gigli GL, Fratticci L, Merlino G, Terzano G, Granella F, Parrino L, Silvestri R, Arico I, Dattola V, Russo G, Luongo C, Cicolin A, Tribolo A, Cavalla P, Savarese M, Trojano M, Ottaviano S, Cirignotta F, Simioni V, Salvi F, Mondino F, Perla F, Chinaglia G, Zuliani C, Cesnik E, Granieri E, Placidi F, Palmieri MG, Manni R, Terzaghi M, Bergamaschi R, Rocchi R, Ulivelli M, Bartalini S, Ferri R, Lo Fermo S, Ubiali E, Viscardi M, Rottoli M, Nobili L, Protti A, Ferrillo F, Allena M, Mancardi G, Guarnieri B, Londrillo F. Multicenter case-control study on restless legs syndrome in multiple sclerosis: the REMS study. Sleep. 2008 Jul;31(7):944-52.

  PMID: 18655317 BACKGROUND

• Braley TJ, Segal BM, Chervin RD. Sleep-disordered breathing in multiple sclerosis. Neurology. 2012 Aug 28;79(9):929-36. doi: 10.1212/WNL.0b013e318266fa9d. Epub 2012 Aug 15.

  PMID: 22895593 BACKGROUND

• Pokryszko-Dragan A, Bilinska M, Gruszka E, Biel L, Kaminska K, Konieczna K. Sleep disturbances in patients with multiple sclerosis. Neurol Sci. 2013 Aug;34(8):1291-6. doi: 10.1007/s10072-012-1229-0. Epub 2012 Oct 30.

  PMID: 23109097 BACKGROUND

• Mendozzi L, Tronci F, Garegnani M, Pugnetti L. Sleep disturbance and fatigue in mild relapsing remitting multiple sclerosis patients on chronic immunomodulant therapy: an actigraphic study. Mult Scler. 2010 Feb;16(2):238-47. doi: 10.1177/1352458509354551. Epub 2009 Dec 22.

  PMID: 20028705 BACKGROUND

• Lanza G, Ferri R, Bella R, Ferini-Strambi L. The impact of drugs for multiple sclerosis on sleep. Mult Scler. 2017 Jan;23(1):5-13. doi: 10.1177/1352458516664034. Epub 2016 Aug 19.

  PMID: 27503906 BACKGROUND

• Siebern AT, Manber R. Insomnia and its effective non-pharmacologic treatment. Med Clin North Am. 2010 May;94(3):581-91. doi: 10.1016/j.mcna.2010.02.005.

  PMID: 20451034 BACKGROUND

• Martires J, Zeidler M. The value of mindfulness meditation in the treatment of insomnia. Curr Opin Pulm Med. 2015 Nov;21(6):547-52. doi: 10.1097/MCP.0000000000000207.

  PMID: 26390335 BACKGROUND

• Gong H, Ni CX, Liu YZ, Zhang Y, Su WJ, Lian YJ, Peng W, Jiang CL. Mindfulness meditation for insomnia: A meta-analysis of randomized controlled trials. J Psychosom Res. 2016 Oct;89:1-6. doi: 10.1016/j.jpsychores.2016.07.016. Epub 2016 Jul 26.

  PMID: 27663102 BACKGROUND

• Abbasi S Ms, Alimohammadi N PhD, Pahlavanzadeh S Ms. Effectiveness of Cognitive Behavioral Therapy on the Quality of Sleep in Women with Multiple Sclerosis: A Randomized Controlled Trial Study. Int J Community Based Nurs Midwifery. 2016 Oct;4(4):320-328.

  PMID: 27713895 BACKGROUND

• Clancy M, Drerup M, Sullivan AB. Outcomes of Cognitive-Behavioral Treatment for Insomnia on Insomnia, Depression, and Fatigue for Individuals with Multiple Sclerosis: A Case Series. Int J MS Care. 2015 Nov-Dec;17(6):261-7. doi: 10.7224/1537-2073.2014-071.

  PMID: 26664331 BACKGROUND

• Kabat-Zinn J (1990). Full Catastrophe Living. New York. NY. Bantam Books

  BACKGROUND

• Ferrarelli F, Smith R, Dentico D, Riedner BA, Zennig C, Benca RM, Lutz A, Davidson RJ, Tononi G. Experienced mindfulness meditators exhibit higher parietal-occipital EEG gamma activity during NREM sleep. PLoS One. 2013 Aug 28;8(8):e73417. doi: 10.1371/journal.pone.0073417. eCollection 2013.

  PMID: 24015304 BACKGROUND

• Britton WB, Haynes PL, Fridel KW, Bootzin RR. Mindfulness-based cognitive therapy improves polysomnographic and subjective sleep profiles in antidepressant users with sleep complaints. Psychother Psychosom. 2012;81(5):296-304. doi: 10.1159/000332755. Epub 2012 Jul 20.

  PMID: 22832540 BACKGROUND

• Britton WB, Haynes PL, Fridel KW, Bootzin RR. Polysomnographic and subjective profiles of sleep continuity before and after mindfulness-based cognitive therapy in partially remitted depression. Psychosom Med. 2010 Jul;72(6):539-48. doi: 10.1097/PSY.0b013e3181dc1bad. Epub 2010 May 13.

  PMID: 20467003 BACKGROUND

• Grossman P, Kappos L, Gensicke H, D'Souza M, Mohr DC, Penner IK, Steiner C. MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial. Neurology. 2010 Sep 28;75(13):1141-9. doi: 10.1212/WNL.0b013e3181f4d80d.

  PMID: 20876468 BACKGROUND

• Simpson R, Booth J, Lawrence M, Byrne S, Mair F, Mercer S. Mindfulness based interventions in multiple sclerosis--a systematic review. BMC Neurol. 2014 Jan 17;14:15. doi: 10.1186/1471-2377-14-15.

  PMID: 24438384 BACKGROUND

• Mohr DC, Lovera J, Brown T, Cohen B, Neylan T, Henry R, Siddique J, Jin L, Daikh D, Pelletier D. A randomized trial of stress management for the prevention of new brain lesions in MS. Neurology. 2012 Jul 31;79(5):412-9. doi: 10.1212/WNL.0b013e3182616ff9. Epub 2012 Jul 11.

  PMID: 22786596 BACKGROUND

• Reynard AK, Sullivan AB, Rae-Grant A. A systematic review of stress-management interventions for multiple sclerosis patients. Int J MS Care. 2014 Fall;16(3):140-4. doi: 10.7224/1537-2073.2013-034.

  PMID: 25337056 BACKGROUND

• Dias RA, Hardin KA, Rose H, Agius MA, Apperson ML, Brass SD. Sleepiness, fatigue, and risk of obstructive sleep apnea using the STOP-BANG questionnaire in multiple sclerosis: a pilot study. Sleep Breath. 2012 Dec;16(4):1255-65. doi: 10.1007/s11325-011-0642-6. Epub 2012 Jan 21.

  PMID: 22270686 BACKGROUND

• Tan A, Yin JD, Tan LW, van Dam RM, Cheung YY, Lee CH. Predicting obstructive sleep apnea using the STOP-Bang questionnaire in the general population. Sleep Med. 2016 Nov-Dec;27-28:66-71. doi: 10.1016/j.sleep.2016.06.034. Epub 2016 Oct 27.

  PMID: 27938922 BACKGROUND

• Chiu HY, Chen PY, Chuang LP, Chen NH, Tu YK, Hsieh YJ, Wang YC, Guilleminault C. Diagnostic accuracy of the Berlin questionnaire, STOP-BANG, STOP, and Epworth sleepiness scale in detecting obstructive sleep apnea: A bivariate meta-analysis. Sleep Med Rev. 2017 Dec;36:57-70. doi: 10.1016/j.smrv.2016.10.004. Epub 2016 Nov 5.

  PMID: 27919588 BACKGROUND

• Abrishami A, Khajehdehi A, Chung F. A systematic review of screening questionnaires for obstructive sleep apnea. Can J Anaesth. 2010 May;57(5):423-38. doi: 10.1007/s12630-010-9280-x. Epub 2010 Feb 9.

  PMID: 20143278 BACKGROUND

• https://www.fitbit.com/charge2

  BACKGROUND

• Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. doi: 10.1093/sleep/26.3.342.

  PMID: 12749557 BACKGROUND

• Van de Water AT, Holmes A, Hurley DA. Objective measurements of sleep for non-laboratory settings as alternatives to polysomnography--a systematic review. J Sleep Res. 2011 Mar;20(1 Pt 2):183-200. doi: 10.1111/j.1365-2869.2009.00814.x.

  PMID: 20374444 BACKGROUND

• de Zambotti M, Baker FC, Willoughby AR, Godino JG, Wing D, Patrick K, Colrain IM. Measures of sleep and cardiac functioning during sleep using a multi-sensory commercially-available wristband in adolescents. Physiol Behav. 2016 May 1;158:143-9. doi: 10.1016/j.physbeh.2016.03.006. Epub 2016 Mar 9.

  PMID: 26969518 BACKGROUND

• Lee HA, Lee HJ, Moon JH, Lee T, Kim MG, In H, Cho CH, Kim L. Comparison of Wearable Activity Tracker with Actigraphy for Sleep Evaluation and Circadian Rest-Activity Rhythm Measurement in Healthy Young Adults. Psychiatry Investig. 2017 Mar;14(2):179-185. doi: 10.4306/pi.2017.14.2.179. Epub 2017 Mar 6.

  PMID: 28326116 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• http://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/isi.php

  BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Gagnon C, Belanger L, Ivers H, Morin CM. Validation of the Insomnia Severity Index in primary care. J Am Board Fam Med. 2013 Nov-Dec;26(6):701-10. doi: 10.3122/jabfm.2013.06.130064.

  PMID: 24204066 BACKGROUND

• http://www.nationalmssociety.org/For-Professionals/Researchers/Resources-for-Researchers/Clinical-Study-Measures/Multiple-Sclerosis-Quality-of-Life-Inventory-(MSQL

  BACKGROUND

• Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

  PMID: 6685237 BACKGROUND

• http://www.nationalmssociety.org/For-Professionals/Researchers/Resources-for-Researchers/Clinical-Study-Measures/Functional-Systems-Scores-(FSS)-and-Expanded-Disab

  BACKGROUND

• https://scireproject.com/outcome-measures/outcome-measure-tool/ashworth-and-modified-ashworth-scale-mas/#1467983894080-2c29ca8d-88af

  BACKGROUND

• http://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/irls.php

  BACKGROUND

• Guarnaccia JB, Njike VY, Dutton A, Ayettey RG, Treu JA, Comerford BP, Sinha R. A pilot, randomized, placebo-controlled study of mindfulness meditation in treating insomnia in multiple sclerosis. BMC Neurol. 2023 Jul 11;23(1):263. doi: 10.1186/s12883-023-03309-0.

  PMID: 37434109 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joseph B Guarnaccia, MD

  Griffin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the MS Treatment Center at Griffin Hospital

Model Details: A placebo-controlled, randomized, single-blinded clinical study involving a projected 90 participants with multiple sclerosis in a 50:50 randomization scheme.

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: May 14, 2019
• Study Start: December 11, 2017
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)