NCT02391298

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

March 8, 2015

Last Update Submit

April 25, 2017

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosisstressmeditationattention

Outcome Measures

Primary Outcomes (2)

  • The Stop Signal Test (SST)

    Measure of Cognitive Inhibition

    Change from baseline of total correct responses on SST at 8 weeks

  • The Freiburg Visual Acuity Test (FrACT)

    Measure of Contrast Sensitivity

    Change from baseline of contrast sensitivity at 8 weeks

Secondary Outcomes (4)

  • The Functional Assessment of Multiple Sclerosis (FAMS) Quality of Life Instrument

    Baseline and 8 weeks

  • Feedback Questionnaire

    8 weeks

  • Mindful Attention Awareness Scale

    Change from baseline in mindfulness skills at 8 weeks

  • Difficulties in Emotion Regulation Scale

    Change from baseline in emotion regulation skills at 8 weeks

Study Arms (1)

Mindfulness Meditation

EXPERIMENTAL

All participants will complete baseline assessments of variables of interest (i.e., levels of mindfulness, contrast sensitivity, cognitive inhibition, and emotional regulation skills). Participants will then undergo 8 weeks of self-directed mindfulness training with re-assessments of variables of interest completed at week 4 and week 8. All participants will be given access to meditation recordings and asked to practice the exercises in a progressive manner from mindfulness of breath to a loving/kindness meditation (each exercise twice per week). Participants will be asked at the end of study for feedback on the acceptability of the program.

Behavioral: Mindfulness Meditation

Interventions

Mindfulness MeditationBEHAVIORAL
Mindfulness Meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Multiple Sclerosis
  • Must be available for 2 in person visits in Massachusetts

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suffolk University

Boston, Massachusetts, 02114, United States

Location

Related Publications (11)

  • 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. doi: 10.1037//0096-1523.10.2.276.

    PMID: 6232345BACKGROUND

  • 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. doi: 10.3758/brm.40.2.479.

    PMID: 18522058BACKGROUND

  • Bach M. The Freiburg Visual Acuity test--automatic measurement of visual acuity. Optom Vis Sci. 1996 Jan;73(1):49-53. doi: 10.1097/00006324-199601000-00008.

    PMID: 8867682BACKGROUND

  • 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. doi: 10.1212/wnl.47.1.129.

    PMID: 8710066BACKGROUND

  • 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. doi: 10.1037/0022-3514.84.4.822.

    PMID: 12703651BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 19014375BACKGROUND

  • 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. doi: 10.1016/s0926-6410(01)00106-9.

    PMID: 11958969BACKGROUND

  • 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.

    PMID: 21790467BACKGROUND

  • 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.

    PMID: 20546836BACKGROUND

  • 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.

    PMID: 19040791BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Elisabeth Moes, PhD

    Suffolk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

March 8, 2015

First Posted

March 18, 2015

Study Start

December 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

US(1)