A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses
An Exploratory Randomised Pilot Trial Examining the Potential Effectiveness of an Online Mindfulness Based Stress Reduction Programme for Informal Caregivers of People With Chronic Illnesses.
Visão geral do estudo
Descrição detalhada
The primary aim of the project is to pilot test the delivery of an online Mindfulness Based Stress Reduction (MBSR) programme to informal caregivers of people with chronic illnesses in one region in Ireland so as to determine the feasibility of delivering the intervention to caregivers in Ireland.
A two-group randomised pilot-feasibility trial comparing the online MBSR programme (intervention) with no programme (control). The MBSR programme is delivered online over 8 weeks. Weekly email and telephone contact will be maintained with participants in the intervention group for the duration of the delivery of the intervention. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed by a trained mindfulness teacher and a mindfulness teacher will conduct the weekly email and telephone call to participants in the intervention group. The study sample are caregivers in the Dublin region who are members of Family Carers' Ireland. A total of 80 caregivers will be recruited to the study, 40 per group, based on 1:1 randomisation using a computer-randomised number generator.
Baseline (pre-intervention) and post intervention participant outcome data (stress, mindfulness and QoL) will be collected using self-reported validated scales administered to participants by post, with stamped-addressed envelopes provided for return. Other pilot measures (i.e. study processes) will be monitored and assessed by the research team to determine potential refinement needs. Feasibility outcome data will be collected by the research team (including time to recruit, attendance at classes, willingness of participants to be randomised) and by the participants (expenses diary) during the study period, using predesigned data collection forms. Mean differences with 95% confidence intervals will be calculated to determine any significant differences between the groups on the outcomes of stress, mindfulness and QoL.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Dublin, Irlanda, dublin 2
- Trinity College Dublin
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Dublin, Irlanda
- Trinity College Dubliln
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Be 18 years of age and over
- Provide unpaid care to an adult or child with a chronic illness
- Not suffer from a severe mental illness
- Be ready to commit to the course at this point in their lives.
Exclusion Criteria:
- Caregivers who are under the age of 18 years.
- Caregivers who have a serious mental illness, such as severe anxiety/depression.
- Caregivers who are in receipt of current and regular treatment from a psychologist or psychiatrist.
- Caregivers with an active or recent physical addiction to alcohol or drugs.
- Caregivers who are already engaged in similar research.
- Caregivers who have already participated in mindfulness based stress reduction (MBSR) or MBCT training.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Cuidados usuais
Sem intervenção
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Experimental: Mindfulness based Stress Reduction
This is an active intervention The MBSR programme is delivered online with weekly telephone and email contact from a trained mindfulness teacher.
Participants are encouraged to practice mindfulness exercises and homework between sessions.
The online programme was developed be a trained mindfulness teacher.
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Mindfulness is a skill that helps people manage their thoughts so that the stressful impact of unhelpful thoughts can be limited.
The aim of the mindfulness based intervention in this study is to help caregivers manage stressful thoughts and events and help them respond to life stressors in a positive way.
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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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Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
Prazo: up to 2 weeks and 6 months post-intervention
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Response to stressful situations
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up to 2 weeks and 6 months post-intervention
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Change over time in Perceived Stress Scale
Prazo: up to 2 weeks and 6 months post-intervention
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perceived stress
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up to 2 weeks and 6 months post-intervention
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Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
Prazo: up to 2 weeks and 6 months post-intervention
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Mindfulness
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up to 2 weeks and 6 months post-intervention
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Change over time in The Adult Carer Quality of Life Questionnaire
Prazo: up to 2 weeks and 6 months post-intervention
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Quality of Life
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up to 2 weeks and 6 months post-intervention
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Caregiver MBCT Programme Evaluation Form
Prazo: up to 2 weeks post-intervention
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programme evaluation
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up to 2 weeks post-intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Margarita Corry, University of Dublin, Trinity College
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12 (Israel lung Association)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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