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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation
Sponsored by
Haley Duncanson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, stress, meditation, attention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Suffolk University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness Meditation

Arm Description

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.

Outcomes

Primary Outcome Measures

The Stop Signal Test (SST)
Measure of Cognitive Inhibition
The Freiburg Visual Acuity Test (FrACT)
Measure of Contrast Sensitivity

Secondary Outcome Measures

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.
Feedback Questionnaire
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
Self-report measure of levels of mindfulness
Difficulties in Emotion Regulation Scale
self-report measure of emotional regulation skills

Full Information

First Posted
March 8, 2015
Last Updated
April 25, 2017
Sponsor
Haley Duncanson
Collaborators
Suffolk University
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1. Study Identification

Unique Protocol Identification Number
NCT02391298
Brief Title
An Online Self-Guided Meditation Course for Individuals With Multiple Sclerosis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haley Duncanson
Collaborators
Suffolk University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, stress, meditation, attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Moes, PhD
Organizational Affiliation
Suffolk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suffolk University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
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6232345
Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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An Online Self-Guided Meditation Course for Individuals With Multiple Sclerosis

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