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- Ensaio Clínico NCT02340754
Mindfulness-based Stress Reduction for Multiple Sclerosis
6 de abril de 2018 atualizado por: Angela Senders, ND, MCR, National University of Natural Medicine
The primary purpose of this study is to assess the feasibility of mindfulness-based stress reduction (MBSR) for adults with any type of multiple sclerosis.
The secondary objectives are to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared to an education control group; and 2) Explore the durability of the effects of MBSR over one year.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
67
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Oregon
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Portland, Oregon, Estados Unidos, 97201
- National College of Natural Medicine
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Men and women 18 years of age or older
- Definite relapsing remitting, secondary progressive, or primary progressive MS by revised McDonald criteria;
- Expanded Disability Severity Scale ≤ 8 at baseline;
- Stable on MS disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
- Mild to moderate stress defined by a score of ≥ 10 on the Perceived Stress Scale at screening;
- Ability to read and write in English;
- Willingness to provide informed consent and comply with study activities, including weekly MBSR sessions and daily practice or weekly Education Control classes.
Exclusion Criteria:
- MBSR or cognitive behavioral therapy training within the last 5 years;
- Current regular meditation or yoga practice (weekly or more often);
- MS exacerbation within 30 days of Baseline Visit;
- Mini-Mental Status Examination (MMSE) score of ≤ 26 at Screening Visit;
- Active suicidal ideation (Beck Depression Inventory) at Screening Visit;
- Reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety;
- Other current life-threatening or severely disabling physical disorders;
- Positive pregnancy urine test at Baseline and women planning pregnancy during the study period (contraception not required);
- Cancer, other than basal or squamous skin cancers; or
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Mindfulness-base Stress Reduction
Mindfulness-based stress reduction is a formalized, experiential, 8-week stress-management program.
Participants attend weekly two-hour classes and a half-day retreat during which they learn mindfulness meditation, breath work, yoga postures, self-reflection and awareness.
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Outros nomes:
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Comparador Ativo: MS Education Control
The MS Education Control program is matched to MBSR for time and attention yet has no overlap with intervention content.
Each two-hour class uses a pamphlet published by the National MS Society to present information about a different MS topic such as Fatigue; Bowel and Bladder Problems; Diet; Spasticity; and Nutritional Supplementation: Vitamins, Minerals, and Herbs.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recruitment: Number of participants enrolled over a ten-month period
Prazo: Recruitment will be tracked monthly with an expected recruitment period of 10 months..
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Feasible recruitment is defined as the ability to recruit and enroll 60 participants with multiple sclerosis (MS) over a ten-month time frame.
Recruitment rate will be calculated as the proportion of eligible patients who provided informed consent per month.
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Recruitment will be tracked monthly with an expected recruitment period of 10 months..
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Adherence to Mindfulness-based Stress Reduction (MBSR): Number of Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework.
Prazo: Baseline to 8 weeks
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Adherence will be tracked with a sign-in/sign out sheet at each class and with daily homework logs.
Attendance will be calculated by a sign in/sign out sheet, being present for at least 75% of a class will count as attended.
Homework will be tabulated as both a frequency count (number of days homework was completed) and amount (total number of minutes completed).
Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework will be recorded as 'adherent'.
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Baseline to 8 weeks
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Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
Prazo: Week 4 and week 8 of the 8 week intervention.
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Adoption is defined as the ability of participants to take part in activities such as yoga poses and meditative exercises.
Qualitative outcomes include a brief, semi-structured focus group conducted at the beginning of the MBSR classes during weeks five and eight.
Focus groups will address successes and any challenges participants may be experiencing.
Focus groups will be audio recorded and transcribed verbatim for qualitative analysis.
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Week 4 and week 8 of the 8 week intervention.
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Completion: Number of participants with complete follow-up at 12 months post-intervention.
Prazo: 14 months
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A feasible completion rate is defined as complete follow-up in at least 70% of enrolled subjects at 12-months post-intervention.
Completion indicates acceptability of a long-term trial and will inform future study designs.
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14 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in Perceived Stress Scale at 8 weeks
Prazo: Baseline and 8 weeks
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Baseline and 8 weeks
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Change in Perceived Stress Scale from 8 weeks to 12 months
Prazo: 8 weeks and 12 months
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8 weeks and 12 months
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Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks
Prazo: Baseline and 8 weeks
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Mental health-related quality of life.
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Baseline and 8 weeks
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Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months
Prazo: 8 weeks and 12 months
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Mental health-related quality of life.
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8 weeks and 12 months
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Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks
Prazo: Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Anxiety
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Baseline and 8 weeks
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Change in PROMIS Anxiety Score from 8 weeks to 12 months
Prazo: 8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Anxiety
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8 weeks and 12 months
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Change in baseline PROMIS Depression Score to 8 weeks
Prazo: Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Depression
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Baseline and 8 weeks
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Change in PROMIS Depression Score from 8 weeks to 12 months
Prazo: 8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Depression
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8 weeks and 12 months
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Change in baseline PROMIS Fatigue Score to 8 weeks
Prazo: Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Fatigue
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Baseline and 8 weeks
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Change in PROMIS Fatigue Score from 8 weeks to 12 months
Prazo: 8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Fatigue
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8 weeks and 12 months
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Change in baseline PROMIS Pain Score to 8 weeks
Prazo: Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Pain
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Baseline and 8 weeks
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Change in PROMIS Pain Score from 8 weeks to 12 months
Prazo: 8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Pain
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8 weeks and 12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
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Publicações Gerais
- Senders A, Bourdette D, Hanes D, Yadav V, Shinto L. Perceived stress in multiple sclerosis: the potential role of mindfulness in health and well-being. J Evid Based Complementary Altern Med. 2014 Apr;19(2):104-11. doi: 10.1177/2156587214523291. Epub 2014 Feb 20.
- Senders A, Sando K, Wahbeh H, Peterson Hiller A, Shinto L. Managing psychological stress in the multiple sclerosis medical visit: Patient perspectives and unmet needs. J Health Psychol. 2016 Aug;21(8):1676-87. doi: 10.1177/1359105314562084. Epub 2014 Dec 19.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2015
Conclusão Primária (Real)
30 de maio de 2017
Conclusão do estudo (Real)
30 de maio de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
11 de janeiro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de janeiro de 2015
Primeira postagem (Estimativa)
19 de janeiro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de abril de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de abril de 2018
Última verificação
1 de abril de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MBSR-MS-001
- 1K23AT008211-01A1 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .