Lifestyle Modification Program for Patients With Chronic Pain Conditions (POSITAG)
Process-outcome-study in the Context of a Lifestyle Modification Program for Patients With Chronic Pain Conditions
In this observational study the effects of a Lifestyle Modification Program - offered as a semi-residential day care clinic - on pain, disability, quality of life and satisfaction with life will be investigated. Furthermore the influence of mindfulness, acceptance and coping, and acquired changes in lifestyle behaviors on the outcome after the program will be evaluated.
Effects will be measured after completion of the program (3 months), and at 6 and 12 months follow up after start of the program, i.e. each outcome measure will be taken 4 times within 12 months.
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Essen、德国、45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
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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
取样方法
研究人群
描述
Inclusion Criteria:
- 18-78
- diagnosed with any chronic pain condition
- physical and mental ability to participate in the program and the study
- written informed consent
Exclusion Criteria:
- participation in any other clinical study focusing on psychological or behavioral intervention
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Lifestyle Modification
All patients with chronic pain conditions participate in a 8-weeks structured group program.
Detailed information on the mindfulness based program can be found in the publication by Paul, A. et al. "An Integrative Day Care Clinic for chronically ill patients: Concept and case presentation" in the European Journal of Integrative Medicine, 2012, 4(4):e455-e459.
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改变生活方式
其他名称：
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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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Pain intensity
大体时间：3 months
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Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
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3 months
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Pain intensity
大体时间：6 months
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Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
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6 months
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Pain intensity
大体时间：12 months
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Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
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12 months
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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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Disability
大体时间：3 months
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pain related disability in the domains everyday activity, leisure and work time, visual analogue scales
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3 months
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Disability (PDI)
大体时间：3 months
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Pain Disability Index (Dillmann et al., 1994) validated questionnaire
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3 months
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Quality of life (SF-36)
大体时间：3 months
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Short Form (36) Health Survey (SF-36) [Bullinger & Kirchberger, 1998].
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3 months
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Depression (BDI)
大体时间：3 months
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Beck Depression Inventory (BDI) [Beck, 1987; Hautzinger, 1992]
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3 months
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Life satisfaction (BMLSS)
大体时间：3 months
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Brief Multidimensional Life Satisfaction Scale (BMLSS) [Büssing & Fischer, 2009]
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3 months
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Acceptance (ERDA)
大体时间：3 months
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Emotional/Rational Disease Acceptance Questionnaire [Büssing et al., 2008, 2010]
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3 months
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Self efficacy
大体时间：3 months
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Questionnaire for pain specific self efficacy (FESS) [Mangels et al., 2009)
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3 months
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Coping (AKU)
大体时间：3 months
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Questionnaire for adaptive coping (AKU) [Büssing & Fischer, 2009]
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3 months
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Mindfulness (CPSC)
大体时间：3 months
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modified Freiburger Mindfulness Inventory (Büssing et al.)
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3 months
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Perceived Stress (PSS-10)
大体时间：3 months
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Perceived Stress Scale (PSS-10) [Büssing, 2011)
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3 months
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Inner Congruence (ICPH)
大体时间：3 months
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Inner Congruence with the exercise practise of meditation/relaxation/yoga ... (Büssing et al., 2011)
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3 months
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Practice Diary
大体时间：3 months
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Patients fill in a week long diary.
Measured are the frequency of health behaviors
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3 months
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Experiences with the program
大体时间：3 months
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- satisfaction with the program and perceived benefit
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3 months
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Safety of the program
大体时间：3 months
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- safety
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3 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Ability and will to change
大体时间：3 months
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Ability and will to change (Büssing, 2008) - also evaluated at 6 and 12 months |
3 months
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Body awareness (BAQ)
大体时间：3 months
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Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Body Awareness Questionnaire (BAQ) (Shields 1989) |
3 months
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Body awareness (BRS)
大体时间：3 months
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Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Body Responsiveness Scale (BRS)(Daubenmier 2005) |
3 months
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Body awareness (SBC)
大体时间：3 months
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Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Scale of Body Connection (SBC)(Price and Thompson 2007) |
3 months
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Body awareness (PAS)
大体时间：3 months
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Newly developed body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Postural Awareness Scale (PAS) (Cramer et al.) |
3 months
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Body awareness (DKB)
大体时间：3 months
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The DKB will be used for mediation and moderator analysis with the outcomes and for validation purposes. - Dresdner Körperbildfragebogen (DKB)(Pöhlmann et al., 2007) |
3 months
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合作者和调查者
调查人员
- 研究主任：Gustav J Dobos, Prof, MD、University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- 首席研究员：Romy Lauche, PhD、University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
- 首席研究员：Holger Cramer, PhD、University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
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.
改变生活方式的临床试验
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