Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)
19 de noviembre de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New York
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Stony Brook, New York, Estados Unidos, 11786-8121
- Stony Brook University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Electronic measure of needle disposals (MEMS TrackCaps)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived Stress Scale-10
Periodo de tiempo: 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
Periodo de tiempo: 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).
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Baseline, 1 X between weeks 3-7, Week 8
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Chicago Multiscale Depression Inventory (CMDI)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Baseline, 1 X between Weeks 3 - 7, Week 8
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Fatigue Severity Scale (FSS)
Periodo de tiempo: 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
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MACFIMS neuropsychological battery
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lauren B Krupp, M.D., Stony Brook University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2011
Finalización primaria (Actual)
1 de abril de 2013
Finalización del estudio (Actual)
1 de noviembre de 2014
Fechas de registro del estudio
Enviado por primera vez
5 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
16 de agosto de 2011
Publicado por primera vez (Estimar)
18 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de noviembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
19 de noviembre de 2014
Última verificación
1 de noviembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Teva186557-1
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