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MBSR for Pain Catastrophizing in SCD

27 de dezembro de 2017 atualizado por: Duke University

A Mindfulness-based Intervention For Pain Catastrophizing In Sickle Cell Disease

Significance: The purpose of this exploratory study is to test the feasibility, accessibility, and effects of a mindfulness-based stress reduction program (MBSR) on reducing pain catastrophizing in persons with sickle cell disease (SCD) and chronic pain. One of the most difficult symptoms for SCD patients to manage is chronic pain. Approximately one-third of SCD patients experience chronic pain, which is associated with pain catastrophizing. Pain catastrophizing is a negative mental state toward pain stimuli and pain experience, and is associated with increased pain severity, pain interference, and lower social functioning, physical functioning, and mental health. There have been no psychobehavioral intervention studies that have attempted to alter the experience of pain catastrophizing in persons with SCD. MBSR is a complementary group-based therapy that emphasizes nonjudgmental awareness of thoughts, feelings, and bodily sensations. With no pharmacological or non-pharmacological treatment for catastrophizing in persons with SCD, MBSR offers a potential solution to this highly significant problem for both SCD patients and providers. This project will be the first randomized controlled trial (RCT) of MBSR to reduce pain catastrophizing, and improve quality of life for SCD patients with chronic pain.

Methods: This study will enroll 60 adult patients with SCD and chronic pain from the Duke Adult Sickle Cell Clinic. Patients will be randomized to a MBSR or wait-listed control group. The MBSR group will complete a 6- week, group-based telephonic MBSR program that is administered by a certified MBSR clinician once a week for 90 minutes. MBSR feasibility, acceptability, and effects on pain catastrophizing will be assessed by questionnaires at baseline, week 1, 3, and 6 in both groups. At the end of week 6, 10 randomly selected MBSR participants will complete semi-scripted telephone interviews to help assess intervention acceptability, and the wait-listed control condition will be offered the same MBSR intervention.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

60

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

  • Estados Unidos
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27701
        • Duke University School of Nursing

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:

  1. Provide written informed consent,
  2. Are >age 21,
  3. Self-identify (to the PI at baseline assessment) that they are experiencing chronic, non-cancer pain that has persisted on most days for more than 6 months, and adversely affects their function or well-being,
  4. are able to speak and read English,
  5. Have access to a telephone (or cell phone) in the home for the intervention and individual assessment interviews (data from the SCD clinic indicate 82% of patients have a cell phone),
  6. Have access to a CD or mp3 player for homework assignments and daily practice,
  7. Are available during the scheduled telephone intervention, and
  8. Complete and return the baseline assessment

Exclusion Criteria:

  • Patients will be excluded if they report previously studying MBSR, currently receiving mindfulness-based or cognitive behavioral therapies, or being regular practitioners of mindfulness, including yoga.

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 de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Mindfulness-Based Stress Reduction
Subjects assigned to the experimental group will participate in a MBSR foundation program, which includes weekly telephonic, group-based, 60-minute MBSR sessions for 6 weeks. The foundation program will introduce subjects to the concept of mindfulness with each week focusing on a different facet. Modeled after Kabat-Zinn's original program, breath awareness (focus on breath and observing thoughts without fighting or following them), body scan (promoting mindfulness of sensations in different parts of body), walking meditation (walking as form of meditation), loving kindness (projection of friendliness and kindness towards oneself and others), and choiceness awareness (awareness of all sensations with equal interest) will be taught.
Comportamental: Mindfulness-based Stress Reduction
A non-pharmacological approach to pain management.
Outro: Wait-listed control group
Subjects assigned to the wait-listed control group will not receive the MBSR program, but will receive weekly reminders of their study participation, be asked to complete the same questionnaires (per telephone script) once every three weeks, and receive the same financial incentives as the MBSR group. Upon completion of the 6-week session, the wait-list control group will be offered the same MBSR program. At that time, a new series of MBSR sessions will be scheduled and offered to the wait-listed control patients. Subjects who elect to participate in MBSR will receive the same packet of materials and measures received by the intervention group and be asked to complete the measures again at baseline, 1, 3, and 6 weeks.
Comportamental: Mindfulness-based Stress Reduction
A non-pharmacological approach to pain management.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Acceptability of MBSR as measured by semi-scripted telephone assessments
Prazo: 6 weeks
Acceptability of the intervention will be assessed by semi-scripted telephone or in-person interviews. The semi-scripted interview will focus on MBSR patients' reflections and expectations of the program, the mindfulness skills they found useful and in what ways, the skills they found less useful and or difficult to implement, and on any changes in thoughts or actions that resulted from the application of the MBSR techniques.
6 weeks
Feasibility of MBSR as measured by recruitment, attrition rates, and practice logs
Prazo: 6 weeks
Feasibility of the intervention will be assessed by recruitment and attrition rates, number of daily mindfulness logs completed, and average number of weekly minutes of mindfulness practice as recorded in logs. Feasibility data will be obtained for both the intervention and control subjects who elect to receive the intervention after the intervention is complete with the MBSR group. However, data will not be analyzed together because the delay to receiving the intervention would affect the results. Data from the control group will be used to help inform future studies.
6 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Pain Catastrophizing as measured by the Pain Catastrophizing Scale
Prazo: baseline, week 1, week 3, and week 6
Descriptive statistics will be used to summarize the pain catastrophizing at week1, 3, and 6, as measured by the Pain Catastrophizing Scale. Trajectory analyses, using a type of mixed effects model known as a random coefficients regression model for repeated measurement, will be conducted to evaluate and compare the rate and pattern of change over the 6 weeks in the MBSR and wait-listed control groups for pain catastrophizing.
baseline, week 1, week 3, and week 6
Change in Mindfulness as measured by the Mindful Attention Awareness Scale
Prazo: baseline, week 1, week 3, and week 6
Descriptive statistics will be used to summarize mindfulness at week1, 3, and 6, as measured by the Mindful Attention Awareness Scale. Trajectory analyses, using a type of mixed effects model known as a random coefficients regression model for repeated measurement, will be conducted to evaluate and compare the rate and pattern of change over the 6 weeks in the MBSR and wait-listed control groups for pain catastrophizing.
baseline, week 1, week 3, and week 6

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Duke University

Colaboradores

National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)

Publicações e links úteis

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Publicações Gerais

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 abril de 2015

Conclusão Primária (Real)

1 de janeiro de 2016

Conclusão do estudo (Real)

1 de janeiro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

9 de fevereiro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de março de 2015

Primeira postagem (Estimativa)

20 de março de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de dezembro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de dezembro de 2017

Última verificação

1 de abril de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Pro00052848
  • F31NR014954-01 (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 .

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