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Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

19 november 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Multiple sclerose

Interventie / Behandeling

Gedragsmatig: Mindfulness based stress reduction (MBSR)

Studietype

Ingrijpend

Inschrijving (Werkelijk)

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

Verenigde Staten
- New York
  - Stony Brook, New York, Verenigde Staten, 11786-8121
    - Stony Brook University

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 tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

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: Enkel

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Electronic measure of needle disposals (MEMS TrackCaps) Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Perceived Stress Scale-10 Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: Baseline and Week 8	DHEA, epinephrine, and norepinephrine.	Baseline and Week 8
Physiologic Maker of Stress Tijdsspanne: Baseline, 1 X between Week 3 - 7, Weeek 8	cortisol	Baseline, 1 X between Week 3 - 7, Weeek 8

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Stony Brook University

Medewerkers

Teva Pharmaceuticals USA

Onderzoekers

Hoofdonderzoeker: Lauren B Krupp, M.D., Stony Brook University

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 2011

Primaire voltooiing (Werkelijk)

1 april 2013

Studie voltooiing (Werkelijk)

1 november 2014

Studieregistratiedata

Eerst ingediend

5 november 2010

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2011

Eerst geplaatst (Schatting)

18 augustus 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

20 november 2014

Laatste update ingediend die voldeed aan QC-criteria

19 november 2014

Laatst geverifieerd