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

Sponsor

Haley Duncanson (Other)

Overall Status

Completed

CT.gov ID

NCT02391298

Collaborator

Suffolk University (Other)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: Mindfulness Meditation	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Meditation 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

Arm

Intervention/Treatment

Experimental: Mindfulness Meditation

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

Outcome Measures

Primary Outcome Measures

The Stop Signal Test (SST) [Change from baseline of total correct responses on SST at 8 weeks]
Measure of Cognitive Inhibition
The Freiburg Visual Acuity Test (FrACT) [Change from baseline of contrast sensitivity at 8 weeks]
Measure of Contrast Sensitivity

Secondary Outcome Measures

The Functional Assessment of Multiple Sclerosis (FAMS) Quality of Life Instrument [Baseline and 8 weeks]
self-report scale that assesses a range aspects of quality of life reported to be important by individuals with MS.
Feedback Questionnaire [8 weeks]
This self-report questionnaire was created in order to gather information regarding feasibility, acceptability, and general impressions of the program from participants.
Mindful Attention Awareness Scale [Change from baseline in mindfulness skills at 8 weeks]
Self-report measure of levels of mindfulness
Difficulties in Emotion Regulation Scale [Change from baseline in emotion regulation skills at 8 weeks]
self-report measure of emotional regulation skills

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.