Use of Expressive Writing in Irritable Bowel Syndrome (IBS)
2017年3月14日 更新者：Boston University
The purpose of this study is to test whether disease-related expressive writing is effective in the treatment of Irritable Bowel Syndrome (IBS).
研究概览
详细说明
Expressive writing involves writing about traumatic, stressful or emotional events.
Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, and pain.
Given its simplicity, and obvious advantages in terms of cost efficiency, expressive writing appears to have great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies.
This modality has not been studied in irritable bowel syndrome (IBS), a common gastrointestinal condition, which is lacking well-defined etiology or treatments and is best understood in a biopsychosocial context.
研究类型
介入性
注册 (实际的)
197
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 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical diagnosis of Irritable Bowel syndrome
Exclusion Criteria:
- Non-English Speakers
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Expressive Writing
Subjects in the Intervention were instructed to write for 30-minute intervals for 4 consecutive days about their deepest thoughts and feelings related to their Irritable Bowel Syndrome.
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Subjects in the Intervention were instructed to write for 30-minute intervals for 4 consecutive days about their deepest thoughts and feelings related to their Irritable Bowel Syndrome.
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|
有源比较器：Control Writing
The participants were instructed to write for 30-minute intervals for 4 consecutive days about all of the actions they performed that day for a 24 hour period.
The subjects were asked not to write about their feelings or thoughts related to these actions.
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Subjects were asked to write about the actions they performed during the last 24 hours.
They were asked not to write about their feelings or thoughts related to these actions.
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无干预：Usual Care
Subjects in this group did not receive an intervention.
They filled out measures at baseline, 1 month, and 3 month follow-up time periods.
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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 |
|---|---|---|
|
IBS-Specific Quality of Life (IBS-QOL)
大体时间：3 months
|
IBSQOL is a measure of IBS - specific quality of life.
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CT3
大体时间：3 months
|
Measure of health-related cognition (catastrophizing or maladaptive coping,and patients' perceived ability to control symptoms)
|
3 months
|
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Health care Utilization (HCU)
大体时间：3 months
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HCU is a measure of frequency and type of health care received for IBS
|
3 months
|
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IBSSS
大体时间：3 months
|
IBSSS provides a disease severity measure
|
3 months
|
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Demographics (DEM-MED)
大体时间：Baseline
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Demographic information
|
Baseline
|
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Cognitive Scale for Functional Bowel Disorders (CGFBD)
大体时间：3 months
|
Measure of IBS related cognitions.
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3 months
|
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Writing Evaluation Questionnaire (WEQ)
大体时间：3 months
|
The WEQ measure obtains subjects' reflections about their writing experience.
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3 months
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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：Albena Halpert, MD、Boston University
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)
2008年9月1日
初级完成 (实际的)
2010年9月1日
研究完成 (实际的)
2010年11月1日
研究注册日期
首次提交
2010年8月12日
首先提交符合 QC 标准的
2010年8月31日
首次发布 (估计)
2010年9月1日
研究记录更新
最后更新发布 (实际的)
2017年3月15日
上次提交的符合 QC 标准的更新
2017年3月14日
最后验证
2017年3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.