Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)
2014年11月19日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
31
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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New York
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Stony Brook、New York、アメリカ、11786-8121
- Stony Brook University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Electronic measure of needle disposals (MEMS TrackCaps)
時間枠：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.
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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.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perceived Stress Scale-10
時間枠：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.
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Baseline, 1 X between weeks 3-7, Week 8
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Holmes and Rahe Social Readjustment Rating Scale (SRRS
時間枠：Baseline, 1 X between weeks 3-7, Week 8
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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).
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Baseline, 1 X between weeks 3-7, Week 8
|
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Chicago Multiscale Depression Inventory (CMDI)
時間枠：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
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Baseline, 1 X betweeen Weeks 3-7, Week 8
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State Trait Anxiety Inventory (STAI)
時間枠：Baseline, 1 X betweeen Weeks 3-7, Week 8
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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.
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Baseline, 1 X betweeen Weeks 3-7, Week 8
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Positive and Negative Affect Scale (PANAS)
時間枠：Baseline, 1 X between Weeks 3 - 7, Week 8
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; Watson, Clark & Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.
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Baseline, 1 X between Weeks 3 - 7, Week 8
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Fatigue Severity Scale (FSS)
時間枠：Baseline, 1 X between Weeks 3 - 7, Week 8
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The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.
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Baseline, 1 X between Weeks 3 - 7, Week 8
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MACFIMS neuropsychological battery
時間枠：Baseline and Week 8
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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.
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Baseline and Week 8
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Expanded Disability Status Scale (EDSS)
時間枠：Baseline and Week 8
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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.
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Baseline and Week 8
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Physiologic Markers of Stress
時間枠：Baseline and Week 8
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DHEA, epinephrine, and norepinephrine.
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Baseline and Week 8
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Physiologic Maker of Stress
時間枠：Baseline, 1 X between Week 3 - 7, Weeek 8
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cortisol
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Baseline, 1 X between Week 3 - 7, Weeek 8
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Lauren B Krupp, M.D.、Stony Brook University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年5月1日
一次修了 (実際)
2013年4月1日
研究の完了 (実際)
2014年11月1日
試験登録日
最初に提出
2010年11月5日
QC基準を満たした最初の提出物
2011年8月16日
最初の投稿 (見積もり)
2011年8月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年11月20日
QC基準を満たした最後の更新が送信されました
2014年11月19日
最終確認日
2014年11月1日
詳しくは
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