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Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

19. november 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • Stony Brook, New York, Forenede Stater, 11786-8121
        • Stony Brook University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Electronic measure of needle disposals (MEMS TrackCaps)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perceived Stress Scale-10
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline and Week 8
DHEA, epinephrine, and norepinephrine.
Baseline and Week 8
Physiologic Maker of Stress
Tidsramme: Baseline, 1 X between Week 3 - 7, Weeek 8
cortisol
Baseline, 1 X between Week 3 - 7, Weeek 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stony Brook University

Samarbejdspartnere

Teva Pharmaceuticals USA

Efterforskere

  • Ledende efterforsker: Lauren B Krupp, M.D., Stony Brook University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2011

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. november 2014

Datoer for studieregistrering

Først indsendt

5. november 2010

Først indsendt, der opfyldte QC-kriterier

16. august 2011

Først opslået (Skøn)

18. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Teva186557-1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Multipel sclerose

Kliniske forsøg med Mindfulness based stress reduction (MBSR)

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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