- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02340754
Mindfulness-based Stress Reduction for Multiple Sclerosis
6 april 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
67
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Oregon
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Portland, Oregon, Förenta staterna, 97201
- National College of Natural Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Andra namn:
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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Recruitment: Number of participants enrolled over a ten-month period
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change from baseline in Perceived Stress Scale at 8 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2015
Primärt slutförande (Faktisk)
30 maj 2017
Avslutad studie (Faktisk)
30 maj 2017
Studieregistreringsdatum
Först inskickad
11 januari 2015
Först inskickad som uppfyllde QC-kriterierna
13 januari 2015
Första postat (Uppskatta)
19 januari 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 april 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 april 2018
Senast verifierad
1 april 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MBSR-MS-001
- 1K23AT008211-01A1 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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