The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients
The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients Evaluating Personal Characteristics and Possible Mechanism
Background: Chronic pain is a common condition in the general population, causing great suffering in both physical and mental aspects. Previous research shows that mindfulness based interventions help chronic pain patients to cope better with their pain, and improve their quality of life. Although evidence support the efficacy of mindfulness based interventions for chronic pain, it is still unclear whether this efficacy involves a direct influence on sensory aspects of pain perception. Further more, the mechanisms of change responsible for the improved life quality and the possible moderating factors that may influence treatment efficacy, are still unknown.
Aim: The purpose of this study is to evaluate the efficacy of mindfulness based intervention on pain perception and quality of life in individuals suffering from chronic pain. The investigators will also evaluate potential mechanisms responsible for the change following mindfulness practice. Finally the investigators will examine the role of personal characteristics as potential moderating factors of mindfulness effect.
Hypothesis: The investigators hypothesize that 1) compared to a waitlist control group, chronic pain patients participating in a full mindfulness based program will report greater improvements in a) pain severity, b) quality of life and psychological symptoms, and c) will demonstrate changes in physiological characteristics of pain. 2) Changes following the mindfulness based program will be mediated by change in pain catastrophizing, self regulation capacity and pain acceptance. 3) The investigators hypothesize that gender, baseline mindfulness, and anxiety sensitivity will moderate the efficacy of the mindfulness based program.
Method: A randomized controlled design will be used to evaluate the efficacy of mindfulness based intervention on pain perception and quality of life in individuals suffering from chronic recurrent low back pain and osteoarthritis. Participants will be randomized to a mindfulness based treatment group, or to a waitlist control group, and will be assessed for psychological variables and psychophysical pain assessment before treatment. Participants allocated to treatment group will then attend six group meetings in which they will learn and practice different mindfulness meditation techniques, and will be asked to practice these techniques on a daily basis. Post treatment assessments will take place at the end of the intervention for both treatment and control groups.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Beer-Sheva、以色列
- Clalit Health Service
-
-
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:
- Patients who suffer from recurrent chronic low back pain
- Patients who suffer from osteoarthritis pains.
- The pain has to be persistent for 3 months or longer and at least moderate in severity.
Exclusion Criteria:
- mental illness with psychotic features
- cognitive impairment
- a history of an inpatient admission for psychiatric disorder within the past two years
- diagnosis of a life threatening medical condition (e.g., cancer)
- patients who are planning to start using other types of alternative interventions parallel to the Mindfulness Program.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention group
The intervention group will participate in the Mindfulness Program consists of one 2-hour session each week for 6 consecutive weeks plus a half day retreat near the end of the intervention.
|
The Mindfulness Program consists of one 2-hour session each week for 6 consecutive weeks plus a half day retreat near the end of the intervention.
Participants will attend weekly group meetings (15-20 individuals per group) in which they will be guided through a progressive experiential exploration of mindfulness.
Participants will be asked to develop a daily meditation practice of 30-45 minutes with audio-recordings for guidance, and will report the amount and type of practice in a daily dairy. .
A psychologist with rich personal experience in mindfulness who is trained in mindfulness based therapy will be responsible for administering the program.
|
|
无干预：Control group
Participants in the control group will be assigned to a waiting list group.
Participants will be told that they will be eligible for the intervention three months after the completion of a preliminary documentation of their symptoms and additional measures.
Participants will complete the same battery of measures according to the same time table as participants in the intervention group.
|
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 |
|---|---|---|
|
change in Brief Pain Inventory Short Form questionnaire (BPI-sf)
大体时间：Administration will take place upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
measures and characterize pain and the interference of pain with the patient's life (reactive dimension).
The BPI questionnaire includes a 0-10 rating scale to measure the pain and the influence of pain on different aspects of daily life (general activity, mood, sleep, relationship with other people, work) that constitute the life impact index
|
Administration will take place upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Brief Symptom Inventory (BSI)
大体时间：upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
53 items and provides nine sub-scale scores measuring a range of psychological symptoms and somatic complaints.
Participants rate on a scale of 0 ('not at all') to 4 ('extremely') how much they were bothered in the last 7 days by each of 18 symptoms, including separate scores for anxiety, depression, somatization, and a global symptom severity index
|
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
|
SF-12 Quality of life
大体时间：upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
The Short-Form General Health Survey is a shorter form of the widely used SF-36 and assesses health-related quality of life.
It consists of 12 items that allow the calculation of 'physical health' (PCS-12) and 'mental health' (MCS-12) summary scales.
|
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
|
Psychophysical measures
大体时间：at the entry into the study, and after 6 weeks
|
Using the The Thermal Sensory Analyzer we will measure Heat/ Cold pain threshold (HPT/CPT)and Supra threshold pain.
|
at the entry into the study, and after 6 weeks
|
|
The Pain Catastrophizing Scale
大体时间：upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
Sullivan, Bishop, & Pivik, 1995) This questionnaire includes 13 items representing the three components of pain catastrophizing: rumination (e.g., "I can't seem to keep it out of my mind"); magnification (e.g., "I wonder whether something serious may happen"); and helplessness (e.g., "There is nothing I can do to reduce the intensity of pain").
|
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
|
Difficulties in Emotion Regulation Scale (DERS)
大体时间：upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
consists of 36 self-report items which comprise six subscales that investigate individuals' complaints about emotional regulation problems.
The scales are: Non-acceptance of Emotional Response, Difficulties engaging in Goal-Directed Behavior, Impulse Control Difficulties, Lack of Emotional Awareness, limited access to Emotion Regulation Strategies and Lack of Emotional Clarity.
Respondents are asked to rate their self-perceptions regarding each item on a 5-point Likert scale, which ranges from "almost never" to "almost always."
|
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
|
The Chronic Pain Acceptance Questionnaire (CPAQ)
大体时间：upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
a 20-item, two factor (Activity Engagement and Pain Willingness) questionnaire, adapted through the process of factor analysis from the original, longer version (Geiser, 1992).
|
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
|
|
Anxiety Sensitivity Index (ASI)
大体时间：at the entry into the study, and after 6 weeks
|
a 16-item measure on which respondents indicate, on a 5-point Likert-type scale (0=very little to 4=very much), the degree to which they fear the potential negative consequences of anxiety-related symptoms and sensations.
The ASI is made up of one higher-order factor (ASI total score) and three lower-order factors: Physical, Psychological, and Social Concerns
|
at the entry into the study, and after 6 weeks
|
|
Mindful Attention Awareness Scale (MAAS)
大体时间：at the entry into the study, and after 6 weeks
|
a 15 item measure of mindfulness.
The item content was design to reflect the opposite of the construct of mindfulness, or: "mindlessness" and thus endorsing the item content at a lower frequency is taken to represent a higher level of mindfulness.
|
at the entry into the study, and after 6 weeks
|
合作者和调查者
调查人员
- 首席研究员：Pesach Shvartzman, M.D、Clalit Health Service
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.