Multiple SclerosisNCT02391298
An Online Self-Guided Meditation Course for Individuals With Multiple Sclerosis
A study testing Mindfulness Meditation in people with Multiple Sclerosis, run by Haley Duncanson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Multiple Sclerosis
- Must be available for 2 in person visits in Massachusetts
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Mindfulness Meditation
- Keywords
- Multiple Sclerosis, stress, meditation, attention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Stop Signal Test (SST)
Measure of Cognitive Inhibition
Measured: Change from baseline of total correct responses on SST at 8 weeks
The Freiburg Visual Acuity Test (FrACT)
Measure of Contrast Sensitivity
Measured: Change from baseline of contrast sensitivity at 8 weeks
Secondary outcomes (4)
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.
Measured: Baseline and 8 weeks
Feedback Questionnaire
This self-report questionnaire was created in order to gather information regarding feasibility, acceptability, and general impressions of the program from participants.
Measured: 8 weeks
Mindful Attention Awareness Scale
Self-report measure of levels of mindfulness
Measured: Change from baseline in mindfulness skills at 8 weeks
Difficulties in Emotion Regulation Scale
self-report measure of emotional regulation skills
Measured: Change from baseline in emotion regulation skills at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haley Duncanson
- Sponsor type
- University, hospital or other
- Collaborators
- Suffolk University
- Responsible party
- Sponsor-investigator, Haley Duncanson, Suffolk University
- Investigators
- Elisabeth Moes, PhD, Principal investigator, Suffolk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391298
- Sponsor's protocol ID
- SuffolkU
- Status last verified
- Apr 2017
- First submitted
- 8 Mar 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 6232345Verbruggen 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.
PubMed 18522058Bach 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.
PubMed 8867682Cella 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.
PubMed 8710066Brown 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.
PubMed 12703651Gratz, 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.
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.
PubMed 19014375Kjaer 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.
PubMed 11958969Jung 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.
PubMed 21790467Jung 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.
PubMed 20546836Phillips 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.
PubMed 19040791
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02391298
- Acronym / sponsor ID
- SuffolkU
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, stress, meditation, attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Haley DuncansonUniversity, hospital or other
- Collaborators
- Suffolk University
- Study start
- Dec 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Experimental | Behavioral: Mindfulness MeditationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Multiple Sclerosis
- Must be available for 2 in person visits in Massachusetts
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation | Behavioural | Mindfulness Meditation |
Primary outcome
The Stop Signal Test (SST)
Time frame: Change from baseline of total correct responses on SST at 8 weeks
Measure of Cognitive Inhibition
The Freiburg Visual Acuity Test (FrACT)
Time frame: Change from baseline of contrast sensitivity at 8 weeks
Measure of Contrast Sensitivity
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 6232345Logan 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.
- Background: PubMed 18522058Verbruggen 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.
- Background: PubMed 8867682Bach 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.
- Background: PubMed 8710066Cella 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.
- Background: PubMed 12703651Brown 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.
- BackgroundGratz, 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: PubMed 19014375Markianos 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.
- Background: PubMed 11958969Kjaer 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.
- Background: PubMed 21790467Jung 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.
- Background: PubMed 20546836Jung 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.
- Background: PubMed 19040791Phillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Moes, PhD principal investigator
Suffolk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Multiple Sclerosis, run by Haley Duncanson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Stop Signal Test (SST) (time frame: Change from baseline of total correct responses on SST at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391298, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.