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Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

2014년 11월 19일 업데이트: 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.

연구 개요

상태

완전한

정황

다발성 경화증

개입 / 치료

행동: Mindfulness based stress reduction (MBSR)

연구 유형

중재적

등록 (실제)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- New York
  - Stony Brook, New York, 미국, 11786-8121
    - Stony Brook University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 지지 요법
할당: 무작위
중재 모델: 병렬 할당
마스킹: 하나의

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Electronic measure of needle disposals (MEMS TrackCaps) 기간: 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.

2차 결과 측정

결과 측정	측정값 설명	기간
Perceived Stress Scale-10 기간: 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 기간: 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) 기간: 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) 기간: 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) 기간: 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) 기간: 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 기간: 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) 기간: 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 기간: Baseline and Week 8	DHEA, epinephrine, and norepinephrine.	Baseline and Week 8
Physiologic Maker of Stress 기간: Baseline, 1 X between Week 3 - 7, Weeek 8	cortisol	Baseline, 1 X between Week 3 - 7, Weeek 8

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Stony Brook University

협력자

Teva Pharmaceuticals USA

수사관

수석 연구원: Lauren B Krupp, M.D., Stony Brook University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 5월 1일

기본 완료 (실제)

2013년 4월 1일

연구 완료 (실제)

2014년 11월 1일

연구 등록 날짜

최초 제출

2010년 11월 5일

QC 기준을 충족하는 최초 제출

2011년 8월 16일

처음 게시됨 (추정)

2011년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 11월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 11월 19일

마지막으로 확인됨