A Mobile Intervention on Values in Chronic Pain Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Pain intensity
研究概览
简要总结
The study aims to test a mobile intervention on values and goals in chronic pain patients. The cognitive behavioral intervention is a 10-day course in which participants complete a brief intervention each day (about 10-20 minutes a day). The content of the intervention includes the definition of values; development of individualized values and personal value-oriented goals; and implementation of personal goals in every day life. To assess the effectiveness of the intervention, we use a multiple baseline single case design. Baseline measurements will be assessed daily between 10 and 17 days (the exact number will be randomized). Daily measurements will continue during the intervention. After the intervention, another post measurement will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking is required, as participants are fully informed about the purpose of the study. Since there is only one arm, masking of the investigators is also not necessary.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic, non-tumor related back pain (pain for at least 6 months)
- •Ownership of a smartphone
- •Numeric Rating Scale for pain result of ≥ 4
排除标准
- •High cognitive impairment (e.g., intellectual disability)
- •Currently in psychotherapeutic treatment
- •Initiation of pain-focused treatment during the study
结局指标
主要结局
Change in Pain intensity
时间窗: Pain intensity is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points)
Numerical Pain Rating Scale (NPRS) Minimum value: 0; Maximum value: 10 (higher scores indicate higher pain intensity)
次要结局
- Change in engaged living(Engaged Living is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points))
- Change in pain catastrophizing(Pain Catastrophizing is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points))
- Change in psychological well-being(Psychological well-being is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points))
- Change in self-efficacy(Self-efficacy is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points))
- Change in chronic pain acceptance(Chronic Pain Acceptance is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points))
- Change in psychological flexibility(Psychological Flexibility is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points))
研究者
Jenny Riecke
Principal Investigator Jenny Riecke
Philipps University Marburg Medical Center