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

April 25, 2017 updated by: Haley Duncanson

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Suffolk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haley Duncanson

Collaborators

Suffolk University

Investigators

  • Principal Investigator: Elisabeth Moes, PhD, Suffolk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 8, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SuffolkU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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