Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
20 de setembro de 2022 atualizado por: Diana Zidarov, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Online Mindfulness-based Stress Reduction Intervention for Chronic Pain in Individuals Waiting for Health Care Services: a Study Protocol for a Pilot Randomized Controlled Trial (RCT)
The goal of this project is to explore the feasibility and the efficacy of a online mindfulness-based stress reduction intervention for people with chronic pain waiting for secondary or tertiary health care services
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
-
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Quebec
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Montreal, Quebec, Canadá, H1V2C8
- Association québécoise de la douleur chronique
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Montreal, Quebec, Canadá, H4B 1T3
- Centre de réadaptation Layton-Lethbridge-Mackay
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Montreal, Quebec, Canadá, H4G 2A3
- Hôpital de Verdun
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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 a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Men and women aged 18-85
- Self-reported diagnosis of chronic non-cancer pain
- Chronic non-cancer pain duration of 3 months or more
- Chronic non-cancer pain experienced during 4 days or more per week
- Average pain intensity of 4 or more out of 10 in the last seven days
- French or English fluency
- Access to Wi-Fi
- Be able to attend a weekly two-hour MBSR virtual session for eight consecutive weeks
Exclusion Criteria:
- Cancer-related chronic pain
- Currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers.
- Current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or MBSR program
- Having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder
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-based stress reduction intervention
Online 8-week group program, once per week
|
An online mindfulness-based stress reduction intervention will be administered in a group format of maximum 15 participants, once a week for 120 minutes for 8 weeks by an experienced therapist trained in MBSR.
Sessions will include sitting and lying meditation, hatha yoga and a body scan where attention is sequentially focused on different parts of the body.
Individual autonomous practice between 30-45 minutes, 6 times / week will also be recommended.
To support individual autonomous practice, a daily diary and two guided videos (around 35 minutes/each) were created.
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Sem intervenção: Waiting list
Controls will not receive any intervention during this time.
They are on chronic pain clinics waiting list
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participants retention rate
Prazo: 2 months
|
The percentage of participants who have completed the 8 online MBSR sessions
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2 months
|
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Participants participation rate
Prazo: 12 months
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The percentage of participants on waiting lists who agreed to participate in the intervention
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Global-10
Prazo: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Change in domains of health and functioning as measured by the PROMIS Global-10, score range is 7-35 with increases in scores meaning better outcome
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
|
|
Patient-Reported Outcomes Measurement Information System 29
Prazo: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
|
Change in 8 health-related quality of life domains as measured by the PROMIS 29.
PROMIS-29 is a generic patient reported outcome measure, which includes four items from each of the seven PROMIS domains (physical function, depression, anxiety, fatigue, sleep disturbance, and ability to participate in social roles and activities, pain interference) and a single item on pain intensity.
Each item has five response options (values 1 to 5), except for the pain intensity item which has eleven response options (values 0 to 10).
A total raw score is computed for each domain as the sum of the response to each question within the domain, leading to seven domain scores, each from 4 to 20.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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French-Canadian Chronic Pain Self-Efficacy Scale
Prazo: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
|
The French-Canadian Chronic Pain Self-Efficacy Scale (Lacasse et al., 2015) is a 6-item scale that measures an individual's confidence in his/her ability to manage chronic pain in general and pain-related symptoms.
Items are rated on a 10-point Likert scale ranging from 1 = not at all confident to 10 = entirely confident.
Score range is 6-60 with higher scores reflecting greater chronic pain self-efficacy.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Chronic Pain Acceptance Questionnaire
Prazo: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
|
The Chronic Pain Acceptance Questionnaire (CPAQ-8; Fish et al., 2010 ) is an 8-item scale comprised of two subscales: activity engagement and pain willingness.
Items are scored on a 7-point Likert scale ranging from 0 = never true to 6 = always true.
Score range is 0-48 with increases in scores meaning better outcome.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Global Rating of Change Scale
Prazo: 3-month follow-up (week 21)
|
The Global Change Rating Scale (11-point visual analogue scale raging from minus 5 to plus 5) will be used to assess the participants' perception of improvement (or decline) in relation to their self-efficacy in manging pain at the end of the MBSR intervention.
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3-month follow-up (week 21)
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Pain Catastrophizing Scale
Prazo: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Change in pain catastrophizing as measured by the Pain Catastrophizing Scale (French Canadian version).
PCS is a 13-item measure using a 5-point Likert scale (0=not at all, 4=all the time) with score range between 0-52 with decreases in scores meaning better outcome.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Pain Disability Index
Prazo: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Change in pain disability as measured by the The French-Canadian Pain Disability Index (score range is 0-70 with decreases in scores meaning better outcome)
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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 (Real)
16 de junho de 2021
Conclusão Primária (Real)
20 de dezembro de 2021
Conclusão do estudo (Real)
24 de janeiro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
8 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de abril de 2021
Primeira postagem (Real)
13 de abril de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de setembro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de setembro de 2022
Última verificação
1 de setembro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CRIR-1499-1120/multi
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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