Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study (BRiC)
2015年10月5日 更新者：Brenda O'Connell、University of Limerick
A Randomised Controlled Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study Protocol
A randomised controlled trial that will compare the effects of a brief benefit -finding writing intervention with an active control condition on quality of life and psychological health among informal caregivers.
研究概览
详细说明
A double-blind, randomized controlled parallel group study design with an equal 1:1 allocation ratio will be employed.
This study will compare the effect of a brief benefit finding writing intervention with a control condition among caregivers.
Caregivers currently caring for people with mental and physical disabilities will be randomised into a two-week, a) a benefit writing group or b) a control writing group.
Caregivers will complete self-report measures relating to their care-recipient and themselves (e.g., illness type, and sociodemographics) and psychometric measures of benefit finding (primary outcome), psychological distress and quality of life(secondary outcomes).
These will be assessed via online software at baseline, immediate post-test and at 3 month follow-up.
Additionally, expectations and fidelity indices will be assessed and qualitative commentary on participation experiences gathered.
研究类型
介入性
注册 (实际的)
88
阶段
- 不适用
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:
- Must be over the age of 18
- Must identify as caring for a family member, friend or relative
- Must be living in Ireland
Exclusion Criteria:
- If the person cared for is living in institutional care
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Benefit-finding Writing Activity
For two weeks, on six days of their choice, caregivers will be instructed to write about their thoughts and feelings in a diary/ notebook about the benefits of caring.
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Caregivers will be instructed to write about the benefits of caring, considering things such as improved social relationship, appreciation of life and loved ones, and the positive consequences with respect to these.
|
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有源比较器：Neutral Writing activity
For two weeks, on six days of their choice, caregivers will be instructed to write about a neutral topic.
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The control group will be instructed to write number of things about the weather that day.
Although the sentences can be as long or as short as they like, they will be encouraged to try and aim for about 3 or 4 sentences at least.
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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 |
|---|---|---|
|
Benefit Finding (Adapted version of the 17-item Benefit Finding Scale; Antoni et al., 2001)
大体时间：Baseline, immediate post-intervention (two weeks), and 3 months
|
Used to assess change in benefit-finding levels over the course of the intervention and follow-up
|
Baseline, immediate post-intervention (two weeks), and 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Caregiver Quality of Life (40 item Adult Carer Quality of Life Questionnaire; Joseph, Becker, Elwick, & Silburn, 2012)
大体时间：Baseline, immediate post-intervention (two weeks), and 3 months
|
This measures quality of life in eight separate domains: support for caring; caring choice; caring stress; money matters; personal growth; sense of value; ability to care; and carer satisfaction.
Used to assess change in quality of life levels over the course of the intervention and follow-up
|
Baseline, immediate post-intervention (two weeks), and 3 months
|
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Psychological Distress (Hospital and Anxiety Depression Scale; Zigmond & Snaith, 1983)
大体时间：Baseline, immediate post-intervention (two weeks), and 3 months
|
Used to assess change in psychological distress levels over the course of the intervention and follow-up, and as a moderator
|
Baseline, immediate post-intervention (two weeks), and 3 months
|
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
- 研究主任：Stephen Gallagher, PhD、University of Limerick, Department of Psychology
- 首席研究员：Charles Brand, MSc、University of Limerick
- 首席研究员：Brenda H O' Connell, B.A、University of Limerick
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
2015年6月1日
初级完成 (实际的)
2015年10月1日
研究完成 (实际的)
2015年10月1日
研究注册日期
首次提交
2015年5月11日
首先提交符合 QC 标准的
2015年5月13日
首次发布 (估计)
2015年5月14日
研究记录更新
最后更新发布 (估计)
2015年10月6日
上次提交的符合 QC 标准的更新
2015年10月5日
最后验证
2015年10月1日
更多信息
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.