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Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

19 november 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Multipel skleros

Intervention / Behandling

Beteende: Mindfulness based stress reduction (MBSR)

Studietyp

Interventionell

Inskrivning (Faktisk)

Fas

Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- New York
  - Stony Brook, New York, Förenta staterna, 11786-8121
    - Stony Brook University

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 till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

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: Enda

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Electronic measure of needle disposals (MEMS TrackCaps) Tidsram: 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.

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Stony Brook University

Samarbetspartners

Teva Pharmaceuticals USA

Utredare

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

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 2011

Primärt slutförande (Faktisk)

1 april 2013

Avslutad studie (Faktisk)

1 november 2014

Studieregistreringsdatum

Först inskickad

5 november 2010

Först inskickad som uppfyllde QC-kriterierna

16 augusti 2011

Första postat (Uppskatta)

18 augusti 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 november 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 november 2014

Senast verifierad