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A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses

2018年5月3日 更新者:Margarita Corry、University of Dublin, Trinity College

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.

This is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses

研究概览

地位

终止

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

11

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Dublin、爱尔兰、dublin 2
        • Trinity College Dublin
      • Dublin、爱尔兰
        • Trinity College Dubliln

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:日常护理
无干预
实验性的: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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
大体时间:up to 2 weeks and 6 months post-intervention
Response to stressful situations
up to 2 weeks and 6 months post-intervention
Change over time in Perceived Stress Scale
大体时间:up to 2 weeks and 6 months post-intervention
perceived stress
up to 2 weeks and 6 months post-intervention
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
大体时间:up to 2 weeks and 6 months post-intervention
Mindfulness
up to 2 weeks and 6 months post-intervention
Change over time in The Adult Carer Quality of Life Questionnaire
大体时间:up to 2 weeks and 6 months post-intervention
Quality of Life
up to 2 weeks and 6 months post-intervention

其他结果措施

结果测量
措施说明
大体时间
Caregiver MBCT Programme Evaluation Form
大体时间:up to 2 weeks post-intervention
programme evaluation
up to 2 weeks post-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Margarita Corry、University of Dublin, Trinity College

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年9月13日

初级完成 (实际的)

2017年10月4日

研究完成 (实际的)

2017年10月4日

研究注册日期

首次提交

2017年2月6日

首先提交符合 QC 标准的

2017年2月8日

首次发布 (估计)

2017年2月9日

研究记录更新

最后更新发布 (实际的)

2018年5月4日

上次提交的符合 QC 标准的更新

2018年5月3日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 12 (Israel lung Association)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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