Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment mindfulness meditation
Sponsor Haley Duncanson
Collaborator Suffolk University
Start date December 2014
End date May 2016
Trial size 40 participants
Trial identifier NCT02391298, SuffolkU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
mindfulness meditation

Primary Outcomes

Measure
The Stop Signal Test (SST)
time frame: 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

Secondary Outcomes

Measure
The Functional Assessment of Multiple Sclerosis (FAMS) Quality of Life Instrument
time frame: Baseline and 8 weeks
Feedback Questionnaire
time frame: 8 weeks
Mindful Attention Awareness Scale
time frame: 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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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.
Principal investigator Elisabeth Moes, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Suffolk University.