Mindfulness-based Stress Reduction for Multiple Sclerosis
6 april 2018 bijgewerkt door: Angela Senders, ND, MCR, National University of Natural Medicine
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) Explore the durability of the effects of MBSR over one year.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
67
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Oregon
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Portland, Oregon, Verenigde Staten, 97201
- National College of Natural Medicine
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Mindfulness-base Stress Reduction
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.
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Andere namen:
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Actieve vergelijker: MS Education Control
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Recruitment: Number of participants enrolled over a ten-month period
Tijdsspanne: Recruitment will be tracked monthly with an expected recruitment period of 10 months..
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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.
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Recruitment will be tracked monthly with an expected recruitment period of 10 months..
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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.
Tijdsspanne: Baseline to 8 weeks
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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'.
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Baseline to 8 weeks
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Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
Tijdsspanne: Week 4 and week 8 of the 8 week intervention.
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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.
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Week 4 and week 8 of the 8 week intervention.
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Completion: Number of participants with complete follow-up at 12 months post-intervention.
Tijdsspanne: 14 months
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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.
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14 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change from baseline in Perceived Stress Scale at 8 weeks
Tijdsspanne: Baseline and 8 weeks
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Baseline and 8 weeks
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Change in Perceived Stress Scale from 8 weeks to 12 months
Tijdsspanne: 8 weeks and 12 months
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8 weeks and 12 months
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Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks
Tijdsspanne: Baseline and 8 weeks
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Mental health-related quality of life.
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Baseline and 8 weeks
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Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months
Tijdsspanne: 8 weeks and 12 months
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Mental health-related quality of life.
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8 weeks and 12 months
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Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks
Tijdsspanne: Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Anxiety
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Baseline and 8 weeks
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Change in PROMIS Anxiety Score from 8 weeks to 12 months
Tijdsspanne: 8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Anxiety
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8 weeks and 12 months
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Change in baseline PROMIS Depression Score to 8 weeks
Tijdsspanne: Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Depression
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Baseline and 8 weeks
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Change in PROMIS Depression Score from 8 weeks to 12 months
Tijdsspanne: 8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Depression
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8 weeks and 12 months
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Change in baseline PROMIS Fatigue Score to 8 weeks
Tijdsspanne: Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Fatigue
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Baseline and 8 weeks
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Change in PROMIS Fatigue Score from 8 weeks to 12 months
Tijdsspanne: 8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Fatigue
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8 weeks and 12 months
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Change in baseline PROMIS Pain Score to 8 weeks
Tijdsspanne: Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Pain
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Baseline and 8 weeks
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Change in PROMIS Pain Score from 8 weeks to 12 months
Tijdsspanne: 8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Pain
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8 weeks and 12 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2015
Primaire voltooiing (Werkelijk)
30 mei 2017
Studie voltooiing (Werkelijk)
30 mei 2017
Studieregistratiedata
Eerst ingediend
11 januari 2015
Eerst ingediend dat voldeed aan de QC-criteria
13 januari 2015
Eerst geplaatst (Schatting)
19 januari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 april 2018
Laatste update ingediend die voldeed aan QC-criteria
6 april 2018
Laatst geverifieerd
1 april 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MBSR-MS-001
- 1K23AT008211-01A1 (Subsidie/contract van de Amerikaanse NIH)
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