A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial

Cesare Cavalera, Francesco Pagnini, Marco Rovaris, Laura Mendozzi, Luigi Pugnetti, Massimo Garegnani, Enrico Molinari, Cesare Cavalera, Francesco Pagnini, Marco Rovaris, Laura Mendozzi, Luigi Pugnetti, Massimo Garegnani, Enrico Molinari

Abstract

Background: Mindfulness-based interventions, modified and shortened versions of meditation teachings, have proved to be effective in the improvement of quality of life in many clinical conditions, including chronic diseases. Preliminary results available in the literature and in clinical experience indicate a high potential for this treatment for the reduction of psychological suffering in people with chronic diseases.

Methods/design: This randomized controlled trial will investigate the impact of a multiple sclerosis (MS) specific telemedicine meditation intervention on the quality of life of people with multiple sclerosis and their caregivers. This trial will recruit 120 patients, men and women, with a diagnosis of relapsing-remitting or secondary progressive MS and their caregivers to participate in a 2-month intervention. Patients will undergo assessments of quality of life, anxiety, depression, quality of sleep, mindfulness and fatigue levels conducted at baseline, at week 8 (conclusion of the intervention) and at week 27 (6 months follow-up). Caregivers will complete assessments conducted at the same time for the same areas, plus caregiver burden. The intervention condition will consist of 2 hours/week of online meditation in a group setting led by a trainer, plus 1 hour/week of individual exercises. The control condition will incorporate a psycho-education online program and will require the same contact time commitment as the intervention condition.

Discussion: Primary outcome measures will consist of assessments of quality of life, anxiety, and depression level. Assessments of mindfulness level, quality of sleep and fatigue level will be considered secondary outcome measures. This investigation will increase understanding of the role of meditation as part of a treatment plan for people with MS and their caregivers. Overall, this study design has the potential to lead to effective meditation intervention strategies for this population and improve their quality of life.

Trial registration: Clinical Trials Register NCT02364505. https://ichgcp.net/clinical-trials-registry/NCT02364505.

Figures

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Fig. 1
Overview of study procedure

References

    1. Hincapie-Zapata ME, Suarez-Escudero JC, Pineda-Tamayo R, Anaya JM. Quality of life in multiple sclerosis and other chronic autoimmune and non-autoimmune diseases. Rev Neurol. 2008;48(5):225–30.
    1. Mullins LL, Cote MP, Fuemmeler BF, Jean VM, Beatty WW, Paul RH. Illness intrusiveness, uncertainty, and distress in individuals with multiple sclerosis. Rehabil Psychol. 2001;46(2):139. doi: 10.1037/0090-5550.46.2.139.
    1. Ensari I, Motl RW, McAuley E, Mullen SP, Feinstein A. Patterns and predictors of naturally occurring change in depressive symptoms over a 30-month period in multiple sclerosis. Mult Scler J. 2014;20(5):602–9. doi: 10.1177/1352458513504251.
    1. Wood B, Van Der Mei IAF, Ponsonby AL, Pittas F, Quinn S, Dwyer T, et al. Prevalence and concurrence of anxiety, depression and fatigue over time in multiple sclerosis. Mult Scler J. 2012;19(2):217–24. doi: 10.1177/1352458512450351.
    1. Riether AM. Anxiety in patients with multiple sclerosis. Semin Clin Neuropsychiatry. 1999;4:103–13.
    1. Siegert RJ, Abernethy DA. Depression in multiple sclerosis: a review. J Neurol Neurosurg Psychiatry. 2005;76(4):469–75. doi: 10.1136/jnnp.2004.054635.
    1. Marziali E, Donahue P. Caring for others: internet video-conferencing group intervention for family caregivers of older adults with neurodegenerative disease. Gerontologist. 2006;46(3):398–403. doi: 10.1093/geront/46.3.398.
    1. Pagnini F, Bosma CM, Phillips D, Langer E. Symptom changes in multiple sclerosis following psychological interventions: a systematic review. BMC Neurol. 2014;14(1):222. doi: 10.1186/s12883-014-0222-z.
    1. Bantornwan S, Watanapa WB, Hussarin P, Chatsiricharoenkul S, Larpparisuth N, Teerapornlertratt T, et al. Role of meditation in reducing sympathetic hyperactivity and improving quality of life in lupus nephritis patients with chronic kidney disease. J Med Assoc Thail Chotmaihet Thangphaet. 2014;97:S101–7.
    1. Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: a meta-analytic review. J Consult Clin Psychol. 2010;78(2):169. doi: 10.1037/a0018555.
    1. Marchand WR. Mindfulness-based stress reduction, mindfulness-based cognitive therapy, and Zen meditation for depression, anxiety, pain, and psychological distress. J Psychiatr Pract. 2012;18(4):233–52. doi: 10.1097/01.pra.0000416014.53215.86.
    1. Greeson J, Eisenlohr-Moul T. Mindfulness-based stress reduction for chronic pain. In: Baer RA, editor. Mindfulness-based treatment approaches: clinician’s guide to evidence base and applications. London: Academic Press; 2014. pp. 269–92.
    1. Marconi A, Gragnano G, Lunetta C, Tagliaferri A, Rossi G, Sansone V, Pagnini F. The experience of meditation for people with amyotrophic lateral sclerosis and their caregivers: a qualitative analysis. Psychol Health Med. In press. doi: 10.1080/13548506.2015.1115110.
    1. Pagnini F, Phillips D. Being mindful about mindfulness. Lancet Psychiatry. 2015;2(4):288–9. doi: 10.1016/S2215-0366(15)00041-3.
    1. Pagnini F, Phillips D, Bosma C, Reece A, Langer E. Mindfulness, physical impairment and psychological well-being in people with amyotrophic lateral sclerosis. Psychol Health. 2015;30(5):503–17. doi: 10.1080/08870446.2014.982652.
    1. Grossman P, Kappos L, Gensicke H, D’souza M, Mohr DC, Penner IK, et al. MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial. Neurology. 2010;75(13):1141–9. doi: 10.1212/WNL.0b013e3181f4d80d.
    1. Eichenberg PDC, Ott R. Klinisch-psychologische Intervention im Internet. Psychotherapeut. 2012;57(1):58–69. doi: 10.1007/s00278-011-0832-5.
    1. Boeschoten RE, Dekker J, Uitdehaag BM, Polman CH, Collette EH, Cuijpers P, et al. Internet-based self-help treatment for depression in multiple sclerosis: study protocol of a randomized controlled trial. BMC Psychiatry. 2012;12(1):137. doi: 10.1186/1471-244X-12-137.
    1. Pagnini F, Di Credico C, Gatto R, Fabiani V, Rossi G, Lunetta C, et al. Meditation training for people with amyotrophic lateral sclerosis and their caregivers. J Altern Complement Med. 2014;20(4):272–5. doi: 10.1089/acm.2013.0268.
    1. Holland N. Comprehensive nursing care in multiple sclerosis. New York: Springer Publishing Company; 2010.
    1. Vickrey BG. Multiple sclerosis quality of life (MSQOL)-54 instrument. Los Angeles: University of California, Los Angeles; 1995.
    1. Solari A, Filippini G, Mendozzi L, Ghezzi A, Cifani S, Barbieri E, et al. Validation of Italian multiple sclerosis quality of life 54 questionnaire. J Neurol Neurosurg Psychiatry. 1999;67(2):158–62. doi: 10.1136/jnnp.67.2.158.
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care. 1992;6:473–83. doi: 10.1097/00005650-199206000-00002.
    1. Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998;51(11):1025–36. doi: 10.1016/S0895-4356(98)00094-8.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67(6):361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Haigh EA, Moore MT, Kashdan TB, Fresco DM. Examination of the factor structure and concurrent validity of the Langer Mindfulness/Mindlessness Scale. Assessment. 2011;18(1):11–26. doi: 10.1177/1073191110386342.
    1. Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical Outcomes Study sleep measure. Sleep Med. 2005;6(1):41–4. doi: 10.1016/j.sleep.2004.07.006.
    1. Groenwold RHH, Donders ART, Roes KCB, Harrell FE, Jr, Moons KGM. Dealing with missing outcome data in randomized trials and observational studies. Am J Epidemiol. 2012;175:210–7. doi: 10.1093/aje/kwr302.
    1. Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002;59(10):877–83. doi: 10.1001/archpsyc.59.10.877.

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