Multiple SclerosisNCT02340754

Mindfulness-based Stress Reduction for Multiple Sclerosis

A study testing Mindfulness-based Stress Reduction in people with Multiple Sclerosis, run by National University of Natural Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary purpose of this study is to assess the feasibility of mindfulness-based stress reduction (MBSR) for adults with any type of multiple sclerosis. The secondary objectives are to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared to an education control group; and 2)… 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-based Stress Reduction
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteUnited States
Study dates: May 2015to 30 May 2017
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

Men and women 18 years of age or older
Definite relapsing remitting, secondary progressive, or primary progressive MS by revised McDonald criteria;
Expanded Disability Severity Scale ≤ 8 at baseline;
Stable on MS disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
Mild to moderate stress defined by a score of ≥ 10 on the Perceived Stress Scale at screening;
Ability to read and write in English;
Willingness to provide informed consent and comply with study activities, including weekly MBSR sessions and daily practice or weekly Education Control classes.

Who cannot join

MBSR or cognitive behavioral therapy training within the last 5 years;
Current regular meditation or yoga practice (weekly or more often);
MS exacerbation within 30 days of Baseline Visit;
Mini-Mental Status Examination (MMSE) score of ≤ 26 at Screening Visit;
Active suicidal ideation (Beck Depression Inventory) at Screening Visit;
Reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety;

Show all 10Show fewer

Other current life-threatening or severely disabling physical disorders;
Positive pregnancy urine test at Baseline and women planning pregnancy during the study period (contraception not required);
Cancer, other than basal or squamous skin cancers; or
Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

National College of Natural Medicine
Portland, Oregon, 97201

Other trials in United States

About this study

Conditions: Multiple Sclerosis
Being tested: Mindfulness-based Stress Reduction, MS Education Control
Keywords: mindfulness, meditation, stress, psychological, quality of life, randomized controlled trial
Medical subject headings: Multiple Sclerosis, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-based Stress ReductionBehavioural
Also called MBSR
MS Education ControlBehavioural

Study groups in NCT02340754
Study group	Role	What they receive
Mindfulness-base Stress Reduction	Experimental	Mindfulness-based stress reduction is a formalized, experiential, 8-week stress-management program. Participants attend weekly two-hour classes and a half-day retreat during which they learn mindfulness meditation, breath work, yoga postures, self-reflection and awareness. Receives: Behavioral: Mindfulness-based Stress Reduction
MS Education Control	Active comparator	The MS Education Control program is matched to MBSR for time and attention yet has no overlap with intervention content. Each two-hour class uses a pamphlet published by the National MS Society to present information about a different MS topic such as Fatigue; Bowel and Bladder Problems; Diet; Spasticity; and Nutritional Supplementation: Vitamins, Minerals, and Herbs. Receives: Behavioral: MS Education Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment: Number of participants enrolled over a ten-month period
Feasible recruitment is defined as the ability to recruit and enroll 60 participants with multiple sclerosis (MS) over a ten-month time frame. Recruitment rate will be calculated as the proportion of eligible patients who provided informed consent per month.
Measured: Recruitment will be tracked monthly with an expected recruitment period of 10 months..
Adherence to Mindfulness-based Stress Reduction (MBSR): Number of Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework.
Adherence will be tracked with a sign-in/sign out sheet at each class and with daily homework logs. Attendance will be calculated by a sign in/sign out sheet, being present for at least 75% of a class will count as attended. Homework will be tabulated as both a frequency count (number of days homework was completed) and amount (total number of minutes completed). Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework will be recorded as 'adherent'.
Measured: Baseline to 8 weeks
Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
Adoption is defined as the ability of participants to take part in activities such as yoga poses and meditative exercises. Qualitative outcomes include a brief, semi-structured focus group conducted at the beginning of the MBSR classes during weeks five and eight. Focus groups will address successes and any challenges participants may be experiencing. Focus groups will be audio recorded and transcribed verbatim for qualitative analysis.
Measured: Week 4 and week 8 of the 8 week intervention.
Completion: Number of participants with complete follow-up at 12 months post-intervention.
A feasible completion rate is defined as complete follow-up in at least 70% of enrolled subjects at 12-months post-intervention. Completion indicates acceptability of a long-term trial and will inform future study designs.
Measured: 14 months

Secondary outcomes (12)

Change from baseline in Perceived Stress Scale at 8 weeks
Measured: Baseline and 8 weeks
Change in Perceived Stress Scale from 8 weeks to 12 months
Measured: 8 weeks and 12 months
Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks
Mental health-related quality of life.
Measured: Baseline and 8 weeks
Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months
Mental health-related quality of life.
Measured: 8 weeks and 12 months
Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks
PROMIS Computerized Adaptive Test of Anxiety
Measured: Baseline and 8 weeks
Change in PROMIS Anxiety Score from 8 weeks to 12 months
PROMIS Computerized Adaptive Test of Anxiety
Measured: 8 weeks and 12 months
Change in baseline PROMIS Depression Score to 8 weeks
PROMIS Computerized Adaptive Test of Depression
Measured: Baseline and 8 weeks
Change in PROMIS Depression Score from 8 weeks to 12 months
PROMIS Computerized Adaptive Test of Depression
Measured: 8 weeks and 12 months
Change in baseline PROMIS Fatigue Score to 8 weeks
PROMIS Computerized Adaptive Test of Fatigue
Measured: Baseline and 8 weeks
Change in PROMIS Fatigue Score from 8 weeks to 12 months
PROMIS Computerized Adaptive Test of Fatigue
Measured: 8 weeks and 12 months
Change in baseline PROMIS Pain Score to 8 weeks
PROMIS Computerized Adaptive Test of Pain
Measured: Baseline and 8 weeks
Change in PROMIS Pain Score from 8 weeks to 12 months
PROMIS Computerized Adaptive Test of Pain
Measured: 8 weeks and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201530 May 2017

First posted19 Jan 2015 (estimated)
Study startMay 2015
Primary completion30 May 2017
Study completion30 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02340754
Sponsor's protocol ID: MBSR-MS-001
Other IDs: 1K23AT008211-01A1
Status last verified: Apr 2018
First submitted: 11 Jan 2015
Last updated: 9 Apr 2018
Results posted: No
Data monitoring committee: Yes

Publications

Senders A, Bourdette D, Hanes D, Yadav V, Shinto L. Perceived stress in multiple sclerosis: the potential role of mindfulness in health and well-being. J Evid Based Complementary Altern Med. 2014 Apr;19(2):104-11. doi: 10.1177/2156587214523291. Epub 2014 Feb 20.
PubMed 24647090
Senders A, Sando K, Wahbeh H, Peterson Hiller A, Shinto L. Managing psychological stress in the multiple sclerosis medical visit: Patient perspectives and unmet needs. J Health Psychol. 2016 Aug;21(8):1676-87. doi: 10.1177/1359105314562084. Epub 2014 Dec 19.
PubMed 25527612

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis

All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness-based Stress Reduction for Multiple Sclerosis
ClinicalTrials.gov ID: NCT02340754
Acronym / sponsor ID: MBSR-MS-001
Conditions: Multiple Sclerosis
Keywords: mindfulness, meditation, stress, psychological, quality of life, randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: National University of Natural MedicineUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
Study start: May 2015
Primary completion: 30 May 2017 (actual)
Study completion: 30 May 2017 (actual)
First posted: 19 Jan 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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mindfulness-base Stress Reduction	Experimental	Behavioral: Mindfulness-based Stress ReductionMindfulness-based stress reduction is a formalized, experiential, 8-week stress-management program. Participants attend weekly two-hour classes and a half-day retreat during which they learn mindfulness meditation, breath work, yoga postures, self-reflection and awareness.
MS Education Control	Active comparator	Behavioral: MS Education ControlThe MS Education Control program is matched to MBSR for time and attention yet has no overlap with intervention content. Each two-hour class uses a pamphlet published by the National MS Society to present information about a different MS topic such as Fatigue; Bowel and Bladder Problems; Diet; Spasticity; and Nutritional Supplementation: Vitamins, Minerals, and Herbs.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Men and women 18 years of age or older
Definite relapsing remitting, secondary progressive, or primary progressive MS by revised McDonald criteria;
Expanded Disability Severity Scale ≤ 8 at baseline;
Stable on MS disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
Mild to moderate stress defined by a score of ≥ 10 on the Perceived Stress Scale at screening;

Key exclusion criteria (10 listed)

MBSR or cognitive behavioral therapy training within the last 5 years;
Current regular meditation or yoga practice (weekly or more often);
MS exacerbation within 30 days of Baseline Visit;
Mini-Mental Status Examination (MMSE) score of ≤ 26 at Screening Visit;
Active suicidal ideation (Beck Depression Inventory) at Screening Visit;

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 ReductionAlso: MBSR	Behavioural	Mindfulness-base Stress Reduction
MS Education Control	Behavioural	MS Education Control

Primary outcome

Recruitment: Number of participants enrolled over a ten-month period
Time frame: Recruitment will be tracked monthly with an expected recruitment period of 10 months..
Feasible recruitment is defined as the ability to recruit and enroll 60 participants with multiple sclerosis (MS) over a ten-month time frame. Recruitment rate will be calculated as the proportion of eligible patients who provided informed consent per month.
Adherence to Mindfulness-based Stress Reduction (MBSR): Number of Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework.
Time frame: Baseline to 8 weeks
Adherence will be tracked with a sign-in/sign out sheet at each class and with daily homework logs. Attendance will be calculated by a sign in/sign out sheet, being present for at least 75% of a class will count as attended. Homework will be tabulated as both a frequency count (number of days homework was completed) and amount (total number of minutes completed). Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework will be recorded as 'adherent'.
Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
Time frame: Week 4 and week 8 of the 8 week intervention.
Adoption is defined as the ability of participants to take part in activities such as yoga poses and meditative exercises. Qualitative outcomes include a brief, semi-structured focus group conducted at the beginning of the MBSR classes during weeks five and eight. Focus groups will address successes and any challenges participants may be experiencing. Focus groups will be audio recorded and transcribed verbatim for qualitative analysis.
Completion: Number of participants with complete follow-up at 12 months post-intervention.
Time frame: 14 months
A feasible completion rate is defined as complete follow-up in at least 70% of enrolled subjects at 12-months post-intervention. Completion indicates acceptability of a long-term trial and will inform future study designs.

12 secondary outcomes

Change from baseline in Perceived Stress Scale at 8 weeks
Time frame: Baseline and 8 weeks
Change in Perceived Stress Scale from 8 weeks to 12 months
Time frame: 8 weeks and 12 months
Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks
Time frame: Baseline and 8 weeks
Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months
Time frame: 8 weeks and 12 months
Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks
Time frame: Baseline and 8 weeks
Change in PROMIS Anxiety Score from 8 weeks to 12 months
Time frame: 8 weeks and 12 months
Change in baseline PROMIS Depression Score to 8 weeks
Time frame: Baseline and 8 weeks
Change in PROMIS Depression Score from 8 weeks to 12 months
Time frame: 8 weeks and 12 months
Change in baseline PROMIS Fatigue Score to 8 weeks
Time frame: Baseline and 8 weeks
Change in PROMIS Fatigue Score from 8 weeks to 12 months
Time frame: 8 weeks and 12 months
Change in baseline PROMIS Pain Score to 8 weeks
Time frame: Baseline and 8 weeks
Change in PROMIS Pain Score from 8 weeks to 12 months
Time frame: 8 weeks and 12 months

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 9 Apr 2018.
Background: PubMed 24647090Senders A, Bourdette D, Hanes D, Yadav V, Shinto L. Perceived stress in multiple sclerosis: the potential role of mindfulness in health and well-being. J Evid Based Complementary Altern Med. 2014 Apr;19(2):104-11. doi: 10.1177/2156587214523291. Epub 2014 Feb 20.
Background: PubMed 25527612Senders A, Sando K, Wahbeh H, Peterson Hiller A, Shinto L. Managing psychological stress in the multiple sclerosis medical visit: Patient perspectives and unmet needs. J Health Psychol. 2016 Aug;21(8):1676-87. doi: 10.1177/1359105314562084. Epub 2014 Dec 19.

Related trials for Multiple Sclerosis

Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis

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.

The record lists no contact. Use the official record to reach the sponsor.

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 in people with Multiple Sclerosis, run by National University of Natural Medicine 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 7 inclusion and 10 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 9 Apr 2018. 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?

Recruitment: Number of participants enrolled over a ten-month period (time frame: Recruitment will be tracked monthly with an expected recruitment period of 10 months..). The study lists 4 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 NCT02340754, which also lists 2 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 9 Apr 2018.