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Mindfulness-based Stress Reduction for Multiple Sclerosis

6 avril 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

67

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Oregon
      • Portland, Oregon, États-Unis, 97201
        • National College of Natural Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Mindfulness-based Stress Reduction
Autres noms:
  • MBSR
Comparateur actif: 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.
Comportemental: MS Education Control

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Recruitment: Number of participants enrolled over a ten-month period
Délai: 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.
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.
Délai: 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'.
Baseline to 8 weeks
Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
Délai: 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.
Week 4 and week 8 of the 8 week intervention.
Completion: Number of participants with complete follow-up at 12 months post-intervention.
Délai: 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.
14 months

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National University of Natural Medicine

Collaborateurs

National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2015

Achèvement primaire (Réel)

30 mai 2017

Achèvement de l'étude (Réel)

30 mai 2017

Dates d'inscription aux études

Première soumission

11 janvier 2015

Première soumission répondant aux critères de contrôle qualité

13 janvier 2015

Première publication (Estimation)

19 janvier 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 avril 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 avril 2018

Dernière vérification

1 avril 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MBSR-MS-001
  • 1K23AT008211-01A1 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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