跳至主要内容
临床试验/NCT03048565
NCT03048565终止不适用

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.

University of Dublin, Trinity College3 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年9月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
3
主要终点
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Usual care

No Intervention

No intervention

Mindfulness based Stress Reduction

Experimental

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.

干预措施: MBSR (Behavioral)

结局指标

主要结局

Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)

时间窗: up to 2 weeks and 6 months post-intervention

Response to stressful situations

Change over time in Perceived Stress Scale

时间窗: up to 2 weeks and 6 months post-intervention

perceived stress

Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)

时间窗: up to 2 weeks and 6 months post-intervention

Mindfulness

Change over time in The Adult Carer Quality of Life Questionnaire

时间窗: up to 2 weeks and 6 months post-intervention

Quality of Life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margarita Corry

Assistant Professor

University of Dublin, Trinity College

研究点 (3)

Loading locations...

相似试验

A Trial of an Online Mindfulness Based Programme for... | 临床试验