Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
研究概览
详细说明
All patients with chronic pancreatitis will be considered for participation in this study. Patients selected for participation will be evaluated 4 weeks prior to the first one-on-one therapy session. A baseline pain score will be assessed using the visual analog pain scale. Narcotic dosage and frequency as well as anti-emetic usage will be evaluated at this time. A pre-treatment quality of life score will be recorded using the SF-12® Patient Questionnaire. Patients will also be queried about the presence of nausea and reflux.
After the pre-intervention evaluations are complete, patients will be randomized into one of two arms: treatment with cognitive behavioral therapy and narcotics as needed or treatment with conventional narcotic analgesics alone. Patients undergoing CBT intervention will participate in eight weekly therapy sessions. Follow-up assessments will be conducted six months and nine months after the last therapy session is completed. The patients will be evaluated based on pain score, narcotic dosage and frequency, anti-emetic usage, quality of life assessment, and pain related hospitalizations.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient must be18 years of age
- Diagnosed with chronic pancreatitis
- Willing and able to comply with the protocol requirements
- Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study
Exclusion Criteria:
1. Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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 |
|---|---|
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实验性的：Cognitive Behavioral Therapy
Patients randomly selected for CBT will attend 8 weekly one-on-one therapy sessions.
Patients will be prescribed conventional narcotic therapy as needed.
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Cognitive behavioral therapy (CBT) uses pain coping skills as a method of managing symptoms associated with chronic pain.Cognitive behavioral therapy teaches patients to identify and modify negative thoughts and behaviors that increase pain intensity, distress, and pain-related disability
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无干预：No Cognitive Behavioral Therapy
Patients randomly selected for no CBT will be treated with conventional narcotic therapy alone.
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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 |
|---|---|---|
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Presence and severity of abdominal pain
大体时间：1 year
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A visual analog scale will be used to measure patients pain pre- and post- intervention
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Life
大体时间：1 year
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quality of life with be measured using the SF-12® Patient Questionnaire
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1 year
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Narcotic Usage
大体时间：1 year
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Narcotic usage will be monitored at each follow-up.
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1 year
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Presence and Severity of Nausea and Reflux
大体时间：1 year
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patients will be queried about the presence and severity of nausea and reflux at each follow-up appointment
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1 year
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Hospitalizations
大体时间：1 year
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Pre- and post- intervention hospitalizations will be recorded
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1 year
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合作者和调查者
出版物和有用的链接
一般刊物
- Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
- Gachago C, Draganov PV. Pain management in chronic pancreatitis. World J Gastroenterol. 2008 May 28;14(20):3137-48. doi: 10.3748/wjg.14.3137.
- Heapy AA, Stroud MW, Higgins DM, Sellinger JJ. Tailoring cognitive-behavioral therapy for chronic pain: a case example. J Clin Psychol. 2006 Nov;62(11):1345-54. doi: 10.1002/jclp.20314.
- Erdek MA, Pronovost PJ. Improving assessment and treatment of pain in the critically ill. Int J Qual Health Care. 2004 Feb;16(1):59-64. doi: 10.1093/intqhc/mzh010.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
Cognitive Behavioral Therapy的临床试验
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
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Abbott Medical Devices完全的