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Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

19 novembre 2014 mis à jour par: Lauren Krupp, Stony Brook University

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Sclérose en plaques

Intervention / Traitement

Comportemental: Mindfulness based stress reduction (MBSR)

Type d'étude

Interventionnel

Inscription (Réel)

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
- New York
  - Stony Brook, New York, États-Unis, 11786-8121
    - Stony Brook University

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 à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

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

Exclusion Criteria:

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.

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: Seul

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Electronic measure of needle disposals (MEMS TrackCaps) Délai: 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.	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.

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Perceived Stress Scale-10 Délai: Baseline, 1 X between weeks 3-7, Week 8	A 10-item scale of global perceived stress, where each item is rated from 1 to 5 according to intensity of stressor.	Baseline, 1 X between weeks 3-7, Week 8
Holmes and Rahe Social Readjustment Rating Scale (SRRS Délai: Baseline, 1 X between weeks 3-7, Week 8	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).	Baseline, 1 X between weeks 3-7, Week 8
Chicago Multiscale Depression Inventory (CMDI) Délai: Baseline, 1 X betweeen Weeks 3-7, Week 8	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	Baseline, 1 X betweeen Weeks 3-7, Week 8
State Trait Anxiety Inventory (STAI) Délai: Baseline, 1 X betweeen Weeks 3-7, Week 8	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.	Baseline, 1 X betweeen Weeks 3-7, Week 8
Positive and Negative Affect Scale (PANAS) Délai: Baseline, 1 X between Weeks 3 - 7, Week 8	; Watson, Clark & Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.	Baseline, 1 X between Weeks 3 - 7, Week 8
Fatigue Severity Scale (FSS) Délai: Baseline, 1 X between Weeks 3 - 7, Week 8	The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.	Baseline, 1 X between Weeks 3 - 7, Week 8
MACFIMS neuropsychological battery Délai: Baseline and Week 8	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.	Baseline and Week 8
Expanded Disability Status Scale (EDSS) Délai: Baseline and Week 8	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.	Baseline and Week 8
Physiologic Markers of Stress Délai: Baseline and Week 8	DHEA, epinephrine, and norepinephrine.	Baseline and Week 8
Physiologic Maker of Stress Délai: Baseline, 1 X between Week 3 - 7, Weeek 8	cortisol	Baseline, 1 X between Week 3 - 7, Weeek 8

Collaborateurs et enquêteurs

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

Parrainer

Stony Brook University

Collaborateurs

Teva Pharmaceuticals USA

Les enquêteurs

Chercheur principal: Lauren B Krupp, M.D., Stony Brook University

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 2011

Achèvement primaire (Réel)

1 avril 2013

Achèvement de l'étude (Réel)

1 novembre 2014

Dates d'inscription aux études

Première soumission

5 novembre 2010

Première soumission répondant aux critères de contrôle qualité

16 août 2011

Première publication (Estimation)

18 août 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

20 novembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 novembre 2014

Dernière vérification