Process-outcome-study in the Context of a Lifestyle Modification Program for Patients With Chronic Pain Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
see above
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with any chronic pain condition
- •physical and mental ability to participate in the program and the study
- •written informed consent
排除标准
- •participation in any other clinical study focusing on psychological or behavioral intervention
结局指标
主要结局
Pain intensity
时间窗: 12 months
Pain intensity according to the German Pain Questionnaire (DSF) (Pfingsten et al., 2007), visual analogue scales
次要结局
- Practice Diary(3 months)
- Disability(3 months)
- Acceptance (ERDA)(3 months)
- Perceived Stress (PSS-10)(3 months)
- Inner Congruence (ICPH)(3 months)
- Safety of the program(3 months)
- Disability (PDI)(3 months)
- Mindfulness (CPSC)(3 months)
- Experiences with the program(3 months)
- Quality of life (SF-36)(3 months)
- Depression (BDI)(3 months)
- Life satisfaction (BMLSS)(3 months)
- Self efficacy(3 months)
- Coping (AKU)(3 months)
研究者
Romy Lauche
Principal Investigator
Universität Duisburg-Essen