GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain (GET Living)
2018年3月27日 更新者：Laura Simons(Giardi)、Boston Children's Hospital
The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain.
Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain.
To examine the efficacy of GET Living in addressing pain-related fears the investigators propose to use a sequential replicated randomized single-case experimental phase design with multiple measures.
The specific aims are to 1) evaluate the effectiveness and acceptability of individually tailored GET Living for children with high pain-related fear and functional disability and 2) define anatomical and resting state connectivity patterns in the brains of children and adolescents with complex chronic pain prior to and after participation in GET Living.
研究概览
研究类型
介入性
注册 (实际的)
34
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
-
-
Massachusetts
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Waltham、Massachusetts、美国、02453
- Boston Children's Hospital Waltham
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-
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
8年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Pain-related fear (score >40 on the Fear of Pain Questionnaire (FOPQ (Simons et al., 2011a))
- Musculoskeletal, neuropathic limb or back pain, or headache
- Functional limitations (score > 12 on the Functional Disability Inventory (FDI (Kashikar-Zuck et al., 2001; Walker and Greene, 1991)).
Exclusion Criteria:
- Significant cognitive impairment (e.g., intellectual disability)
- Serious psychopathology (e.g., active suicidality).
- Acute trauma (e.g., spondylolithesis, disk herniation, fracture, acute tendonitis)
- Systemic disease in active inflammatory state
- Biomechanical deficit that would limit ability to engage in exposure activities (e.g. severe muscle atrophy)
- Making gains in current physical therapy or have not had physical therapy, but it is clearly indicated
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：GET Living Treatment
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GET Living is an exposure based treatment jointly delivered by a cognitive-behavioral therapist and physical therapy to help children and adolescents suffering with chronic pain and headache progressively return to valued life activities.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Decrease in Fear of Pain
大体时间：Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average
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Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Decrease in Functional Disability
大体时间：Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average
|
Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average
|
|
Improvement in School Functioning
大体时间：Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average
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Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average
|
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Decrease in Pain Catastrophizing
大体时间：Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average
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Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average
|
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Decrease in Pain Intensity
大体时间：Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average
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Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average
|
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Increase in Physical Activity
大体时间：Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average
|
Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average
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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：Laura E Simons, PhD、Boston Children's Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2013年10月1日
初级完成 (实际的)
2018年1月1日
研究完成 (实际的)
2018年1月1日
研究注册日期
首次提交
2013年10月22日
首先提交符合 QC 标准的
2013年10月28日
首次发布 (估计)
2013年11月3日
研究记录更新
最后更新发布 (实际的)
2018年3月29日
上次提交的符合 QC 标准的更新
2018年3月27日
最后验证
2018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.