An Online Self-Guided Meditation Course for Individuals With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

An Examination of Potential Neurochemical and Cognitive Mediators of the Relationship Between Mindfulness and Emotion Regulation in Individuals With Multiple Sclerosis: An Internet Based Self-Guided Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391298
• Other study ID #: SuffolkU
• Status: Completed
• Phase: N/A
• First received: March 8, 2015
• Last updated: April 25, 2017
• Start date: December 2014
• Est. completion date: May 2016

Study information

• Verified date: April 2017
• Source: Suffolk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine whether meditation delivered by the internet improves mood and attention as well as increases levels of dopamine in individuals who have been diagnosed with Multiple Sclerosis.

Description:

Multiple Sclerosis (MS) is thought to involve a chronic, autoimmune inflammatory process in which one's own immune system attacks the myelin sheath surrounding axons in the central nervous system. MS is associated with many symptoms that decrease one's quality of life including pain, spasticity, fatigue, bowel and bladder problems, dizziness, cognitive difficulties, and depression. There is currently no cure for MS.

Decreased levels of dopamine (DA) have been measured in the cerebrospinal fluid of those with the primary progressive type of MS. In individuals with the relapsing- remitting type of MS, dopamine levels showed a negative correlation to disease severity such that as dopamine levels decreased, disease severity increased. Additionally, many symptoms of MS are related to dopaminergic dysfunction and/or abnormalities in dopamine rich brain areas. Dopamine levels have been shown to increase via active meditation during PET imaging in long term meditators. Other studies have also linked dopamine release to meditation in the peripheral nervous system (via measures of a DA metabolite in blood plasma levels). It is not clear whether brief meditation training in naive participants may have similar effects. Whether meditation could enhance dopamine levels in patients with MS or meditation naïve individuals has not been studied. Both dopamine and mindfulness training have been linked to improved attention and emotion regulation. Research has also indicated that attentional failures and infrequent use of emotion regulation strategies predicted poorer quality of life in patients with MS. Thus, there is sufficient evidence to suggest that meditation can enhance attention, emotion regulation, and quality of life in individuals with MS and that dopamine may be a neurochemical mechanism for this change.

This study is an open trial pilot design with multiple assessments on measures of mindfulness, dopamine, inhibition, and emotion regulation. The primary goal of the current study is evaluate the efficacy of an internet based mindfulness program for individuals with MS. The investigators hypothesize that individuals with MS will show increased levels of mindfulness and improved emotion regulation and cognitive inhibition skills after the course. In addition, The investigators hypothesize that contrast sensitivity (a proxy measure of retinal dopamine levels) will increase after the course. A secondary goal of this study is to examine potential cognitive and neurochemical mechanisms of mindfulness in relation to emotion regulation. Specifically, the investigators propose to examine whether dopamine and cognitive inhibition mediate the relationship between mindfulness and improved emotion regulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Multiple Sclerosis

• Must be available for 2 in person visits in Massachusetts

Exclusion Criteria:

• Patients with psychosis.

• Self-reported disorders of the central nervous system other than MS.

• Participants currently engaged in weekly psychotherapy who are unable to reduce session to once per month for the duration of the study.

• Sensorimotor limitations that would confound test results.

• Daily meditation practice (current or during the last 3 months).

• Medication changes in the past 3 months.

• Participants who, due to their MS are medically unstable. This will be defined as anyone who is actively relapsing at the time of recruitment (or within the last two weeks), or who becomes symptomatic during training.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Mindfulness Meditation

Locations

Country	Name	City	State
United States	Suffolk University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Haley Duncanson	Suffolk University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Bach M. The Freiburg Visual Acuity test--automatic measurement of visual acuity. Optom Vis Sci. 1996 Jan;73(1):49-53. — View Citation

Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. — View Citation

Cella DF, Dineen K, Arnason B, Reder A, Webster KA, karabatsos G, Chang C, Lloyd S, Steward J, Stefoski D. Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology. 1996 Jul;47(1):129-39. — View Citation

Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54.

Jung YH, Kang DH, Byun MS, Shim G, Kwon SJ, Jang GE, Lee US, An SC, Jang JH, Kwon JS. Influence of brain-derived neurotrophic factor and catechol O-methyl transferase polymorphisms on effects of meditation on plasma catecholamines and stress. Stress. 2012 Jan;15(1):97-104. doi: 10.3109/10253890.2011.592880. Epub 2011 Jul 26. — View Citation

Jung YH, Kang DH, Jang JH, Park HY, Byun MS, Kwon SJ, Jang GE, Lee US, An SC, Kwon JS. The effects of mind-body training on stress reduction, positive affect, and plasma catecholamines. Neurosci Lett. 2010 Jul 26;479(2):138-42. doi: 10.1016/j.neulet.2010.05.048. Epub 2010 May 28. — View Citation

Kjaer TW, Bertelsen C, Piccini P, Brooks D, Alving J, Lou HC. Increased dopamine tone during meditation-induced change of consciousness. Brain Res Cogn Brain Res. 2002 Apr;13(2):255-9. — View Citation

Logan GD, Cowan WB, Davis KA. On the ability to inhibit simple and choice reaction time responses: a model and a method. J Exp Psychol Hum Percept Perform. 1984 Apr;10(2):276-91. — View Citation

Markianos M, Koutsis G, Evangelopoulos ME, Mandellos D, Karahalios G, Sfagos C. Relationship of CSF neurotransmitter metabolite levels to disease severity and disability in multiple sclerosis. J Neurochem. 2009 Jan;108(1):158-64. doi: 10.1111/j.1471-4159.2008.05750.x. Epub 2008 Nov 12. — View Citation

Phillips LH, Saldias A, McCarrey A, Henry JD, Scott C, Summers F, Whyte M. Attentional lapses, emotional regulation and quality of life in multiple sclerosis. Br J Clin Psychol. 2009 Mar;48(Pt 1):101-6. doi: 10.1348/014466508X379566. Epub 2008 Nov 26. — View Citation

Verbruggen F, Logan GD, Stevens MA. STOP-IT: Windows executable software for the stop-signal paradigm. Behav Res Methods. 2008 May;40(2):479-83. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Stop Signal Test (SST)	Measure of Cognitive Inhibition	Change from baseline of total correct responses on SST at 8 weeks
Primary	The Freiburg Visual Acuity Test (FrACT)	Measure of Contrast Sensitivity	Change from baseline of contrast sensitivity at 8 weeks
Secondary	The Functional Assessment of Multiple Sclerosis (FAMS) Quality of Life Instrument	self-report scale that assesses a range aspects of quality of life reported to be important by individuals with MS.	Baseline and 8 weeks
Secondary	Feedback Questionnaire	This self-report questionnaire was created in order to gather information regarding feasibility, acceptability, and general impressions of the program from participants.	8 weeks
Secondary	Mindful Attention Awareness Scale	Self-report measure of levels of mindfulness	Change from baseline in mindfulness skills at 8 weeks
Secondary	Difficulties in Emotion Regulation Scale	self-report measure of emotional regulation skills	Change from baseline in emotion regulation skills at 8 weeks