Multiple SclerosisNCT01419301
Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)
A study testing Mindfulness based stress reduction (MBSR) in people with Multiple Sclerosis, run by Stony Brook University at 1 site in United States.
Trial summary
This study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. Medication compliance is measured by the weight of discarded needles. The investigators will be administering neuropsychological testing at baseline and the final visit. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mindfulness based stress reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with either definite MS according to the revised McDonald criteria (Polman 2005) or patients with CIS (defined as an initial MS relapse with objective documentation and 2 or more lesions within the CNS of which at least one must involve the brain)
- Patients on GA therapy for at least 6 months
- Age 18 - 70
Who cannot join
- Unwilling to comply with study procedures
- Use of other DMT in conjunction with GA
- Unable to provide informed consent.
- Current (past 30 days) substance abuse
- Newly initiated (past 30 days) psychiatry treatment
- Enrolled in another program of meditation in the past six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University
Stony Brook, New York, 11786-8121
About this study
Official title: Mindfulness Based Stress Reduction in MS
This study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. Medication compliance is measured by the weight of discarded needles. The investigators will be administering neuropsychological testing at baseline and the final visit. The subjects will complete self-report assessments during their 8 weeks in the study.
Group A will have additional weekly phone support for meditation, while Group B will have meditation training only.
- Conditions
- Multiple Sclerosis
- Being tested
- Mindfulness based stress reduction (MBSR)
- Keywords
- multiple sclerosis, glatiramer acetate, stress reduction, medication adherence
- Medical subject headings
- Multiple Sclerosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based stress reduction (MBSR)Behavioural
Mindfulness based stress reduction (MBSR) is program based on daily meditation practice that guides an individual towards increased awareness and self-regulation of thoughts and actions. MBSR is easier to implement and may be shown to be more effective than cognitive-behavioral stress reduction, and is more applicable to patients with chronic illness.
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronic measure of needle disposals (MEMS TrackCaps)
During the six-week MSBR program, medication adherence will be monitored with a widely used electronic measure of needle disposals (MEMS TrackCaps) This method has been demonstrated to be more accurate in MS than data obtained from either self-report or interview. At one month intervals the patient will bring the needle container to the Study Coordinator. All patients who attend at least introduction session and one telephone session will be included in the analysis.
Measured: Medication adherence will be measured by total number of missed doses, calculated from total needle disposals. The total number of missed doses across the six weeks will be compared between the two treatment groups at study end.
Secondary outcomes (10)
Perceived Stress Scale-10
A 10-item scale of global perceived stress, where each item is rated from 1 to 5 according to intensity of stressor.
Measured: Baseline, 1 X between weeks 3-7, Week 8
Holmes and Rahe Social Readjustment Rating Scale (SRRS
Stressful life events will be rated using the SRRS, which asks subjects to check if they have experienced any of a series of life events. We will use a modification of the scale used in previous MS research that eliminates several items specifically associated with MS disease activity (e.g., "major illness or injury", "sexual difficulties", "pregnancy"). The SRRS differentiates three types of stress: positive ("outstanding personal achievement"), major negative stress (death of family member), conflict and disruption in routine (e.g., family or job conflict, life changes).
Measured: Baseline, 1 X between weeks 3-7, Week 8
Chicago Multiscale Depression Inventory (CMDI)
CMDI is a self-report questionnaire designed specifically for use in MS and other medical patient groups. It has vegetative, mood, and evaluative scales consisting of 14 items each. The use of the CMDI makes it possible to separate out neurovegetative symptoms of depression which are a potential confound in medical populations such as MS
Measured: Baseline, 1 X betweeen Weeks 3-7, Week 8
State Trait Anxiety Inventory (STAI)
The STAI is a widely used measure of state and trait anxiety. We will focus on the measurement of state related anxiety in this study.
Measured: Baseline, 1 X betweeen Weeks 3-7, Week 8
Positive and Negative Affect Scale (PANAS)
; Watson, Clark \& Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.
Measured: Baseline, 1 X between Weeks 3 - 7, Week 8
Fatigue Severity Scale (FSS)
The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.
Measured: Baseline, 1 X between Weeks 3 - 7, Week 8
MACFIMS neuropsychological battery
At baseline and study end, an abbreviated version of the MACFIMS will be administered. This is a standard neurocognitive battery used with studies of MS subjects and includes the SDMT, PASAT, SRT, BVMT, and 9-hole peg test.
Measured: Baseline and Week 8
Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale is the oldest and probably the most widely utilized assessment instruments in MS for determination of neurological impairment in MS. It is the standard for characterization of MS patients and for outcomes of clinical trials. It will be used to characterize patients' level of disability.
Measured: Baseline and Week 8
Physiologic Markers of Stress
DHEA, epinephrine, and norepinephrine.
Measured: Baseline and Week 8
Physiologic Maker of Stress
cortisol
Measured: Baseline, 1 X between Week 3 - 7, Weeek 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Lauren Krupp, Stony Brook University
- Investigators
- Lauren B Krupp, M.D., Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419301
- Sponsor's protocol ID
- Teva186557-1
- Status last verified
- Nov 2014
- First submitted
- 5 Nov 2010
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction in MS
- ClinicalTrials.gov ID
- NCT01419301
- Acronym / sponsor ID
- Teva186557-1
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, glatiramer acetate, stress reduction, medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Aug 2011 (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.
This study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. Medication compliance is measured by the weight of discarded needles. The investigators will be administering neuropsychological testing at baseline and the final visit. The subjects will complete self-report assessments during their 8 weeks in the study.
Group A will have additional weekly phone support for meditation, while Group B will have meditation training only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with either definite MS according to the revised McDonald criteria (Polman 2005) or patients with CIS (defined as an initial MS relapse with objective documentation and 2 or more lesions within the CNS of which at least one must involve the brain)
- Patients on GA therapy for at least 6 months
- Age 18 - 70
Key exclusion criteria (6 listed)
- Unwilling to comply with study procedures
- Use of other DMT in conjunction with GA
- Unable to provide informed consent.
- Current (past 30 days) substance abuse
- Newly initiated (past 30 days) psychiatry treatment
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 based stress reduction (MBSR)Mindfulness based stress reduction (MBSR) is program based on daily meditation practice that guides an individual towards increased awareness and self-regulation of thoughts and actions. MBSR is easier to implement and may be shown to be more effective than cognitive-behavioral stress reduction, and is more applicable to patients with chronic illness. | Behavioural | – |
Primary outcome
Electronic measure of needle disposals (MEMS TrackCaps)
Time frame: Medication adherence will be measured by total number of missed doses, calculated from total needle disposals. The total number of missed doses across the six weeks will be compared between the two treatment groups at study end.
During the six-week MSBR program, medication adherence will be monitored with a widely used electronic measure of needle disposals (MEMS TrackCaps) This method has been demonstrated to be more accurate in MS than data obtained from either self-report or interview. At one month intervals the patient will bring the needle container to the Study Coordinator. All patients who attend at least introduction session and one telephone session will be included in the analysis.
10 secondary outcomes
Perceived Stress Scale-10
Time frame: Baseline, 1 X between weeks 3-7, Week 8
Holmes and Rahe Social Readjustment Rating Scale (SRRS
Time frame: Baseline, 1 X between weeks 3-7, Week 8
Chicago Multiscale Depression Inventory (CMDI)
Time frame: Baseline, 1 X betweeen Weeks 3-7, Week 8
State Trait Anxiety Inventory (STAI)
Time frame: Baseline, 1 X betweeen Weeks 3-7, Week 8
Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, 1 X between Weeks 3 - 7, Week 8
Fatigue Severity Scale (FSS)
Time frame: Baseline, 1 X between Weeks 3 - 7, Week 8
MACFIMS neuropsychological battery
Time frame: Baseline and Week 8
Expanded Disability Status Scale (EDSS)
Time frame: Baseline and Week 8
Physiologic Markers of Stress
Time frame: Baseline and Week 8
Physiologic Maker of Stress
Time frame: Baseline, 1 X between Week 3 - 7, Weeek 8
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 20 Nov 2014.
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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.
Lauren B Krupp, M.D. principal investigator
Stony Brook 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 based stress reduction (MBSR) in people with Multiple Sclerosis, run by Stony Brook University 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 3 inclusion and 6 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 20 Nov 2014. 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?
Electronic measure of needle disposals (MEMS TrackCaps) (time frame: Medication adherence will be measured by total number of missed doses, calculated from total needle disposals. The total number of missed doses across the six weeks will be compared between the two treatment groups at study end.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2014; AzTrials last refreshed its copy on 27 Oct 2026.