Brief Mindfulness and Nutrition-Based Interventions for Chronic Pain: Strategies to Ease Pain (STEP)
Brief Mindfulness-Based Intervention for Chronic Pain: A Pilot Randomized Clinical Trial
研究概览
地位
详细说明
Participants. To gather pilot data on the effects of BMBI, the investigators will aim to enroll up to 60 participants (up to 30 in each condition). Participants will be adults with chronic non-cancer pain (daily pain for at least 3 months).
Outcomes. Outcome measures were selected based on existing recommendations, including IMMPACT guidelines, for efficacy trials in chronic pain.
- Aim #1: Test the effects of BMBI, relative to control, on central pain processing using quantitative sensory testing. Quantitative sensory testing (cold pressor test and pressure algometer) will be used to characterize pain processing: pain threshold (i.e., when pain is first detected), pain tolerance (i.e., the duration of time that pain can be tolerated), and pain severity (i.e., intensity of pain). In the cold pressor test, a participant will be asked to place his or her hand in an ice bath until the pain is too great to remain in the water. Consistent with past research, a 15 liter refrigerated circulator (Polyscience MX15R-30-A11B) with water temperature set as low as 1°C will be used. In the pressure algometer test, the algometer will be used to apply pressure to the skin until the pain can no longer be tolerated. The investigators will utilize a device widely used in alogmeter pain research (Wagnder Force One Alogmeter FIPX).
- Aim #2: Test the immediate effects of BMBI, relative to control, on state self-report measures of pain, negative affect, and decentering. State self-report outcomes include: state decentering (7-item Decentering Subscale of the Toronto Mindfulness Scale), state pain intensity (1 item from the Brief Pain Inventory), state pain unpleasantness (1-item rated on 0-10 scale), state anxiety (1-item rated on 0-10 scale), state distress (1-item rated on 0-10 scale), state relaxation (1-item rated on 0-10 scale), and outcome expectancies (5-item Outcome Expectancies Questionnaire).
- Aim #3: Test longer-term effects of BMBI, relative to control, on trait self-report measures of pain, negative affect, trait mindfulness, and well-being. Trait self-report outcomes include: pain intensity and interference (9-item Brief Pain Inventory), anxiety and depression (14-item Hospital Anxiety and Depression Scale), trait mindfulness (15-item Mindful Attention Awareness Scale), psychological well-being (10-item Schwartz Outcome Scale), and home practice over the 4-week follow-up period (TLFB method).
Procedure. Participants will be recruited primarily via flyers and postings in newspapers and on the Internet. Prospective participants will be screened by phone (about 30 minutes). Provisionally eligible participants will be asked to attend a 1-hour appointment, which will begin with informed consent procedures (5-10 minutes) and a pre-intervention assessment (about 20 minutes; includes demographics questionnaire, self-report outcome measures, and quantitative sensory testing).
Eligible participants will be randomized to a condition, complete a 20-minute session of either BMBI or Control, and undergo a postintervention assessment (about 10 minutes; includes self-report outcome measures and quantitative sensory testing). Following the assessment, participants will be encouraged to practice the technique associated with their intervention (i.e., practicing mindfulness technique in BMBI, preparing healthy meals in Control) 20 minutes/day for 1 week at home and to track their practice and opioid use during the follow-up period; the follow-up assessments will be conducted over the phone by a research assistant and include the self-report outcome measures (no quantitative sensory testing). All study procedures are anticipated to last 2 hours and 30 minutes (30 minutes for screening, 1 hour for in-person appointment, and 30 minutes for each follow-up assessment).
Interventions: The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study. Relative to full-length interventions, the investigators will employ a brief intervention (i.e., one, 20-minute session) that could be delivered in routine clinical care, e.g., in primary care, and that could overcome cost and time/effort barriers associated with longer treatments. The 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes). BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 1 week (a handout and link to an online guided mindfulness practice will be provided).
The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain. Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI. The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes). Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 1 week (a handout and link to online resources will be provided).
研究类型
阶段
- 不适用
联系人和位置
学习地点
-
-
Wisconsin
-
Madison、Wisconsin、美国、53715
- University of Wisconsin
-
-
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:
- English-speaking
- ≥ 18 years old
- Chronic non-cancer pain (daily pain for at least 3 months)
- Average daily pain score ≥3 on a 0-10 numerical rating scale (question from the Brief Pain Inventory)
- Treatment with ≥30 mg/day of morphine-equivalent dose for ≥3 months
- Capable of giving informed consent
- Willing to complete all study activities
Exclusion Criteria:
- Cancer pain
- Current pregnancy
- Diagnosed with psychotic or bipolar (mania) disorders ("active" in the prior 12 months)
- Inability to safely or reliably participate in the study
- Regular mindfulness meditation practice
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:Brief Mindfulness-Based Intervention
Those assigned to the Brief Mindfulness-Based Intervention (BMBI) Arm will receive BMBI.
|
The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study.
Relative to full-length interventions, we will employ a brief intervention; the 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes).
BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 1 week (a handout and link to an online guided mindfulness practice will be provided).
|
有源比较器:Control/Nutrition Education
Those assigned to the Control/Nutrition Education Arm will receive the nutrition education intervention.
|
The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain.
Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI.
The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes).
Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 1 week (a handout and link to online resources will be provided).
|
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 |
---|---|---|
Cold pressor testing
大体时间:1 hour
|
Cold pressor testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity).
In the cold pressor test, a participant is asked to place his or her hand and forearm in an ice bath until the pain is too great to remain in the water.
Consistent with past research, a 15 liter refrigerated circulator (Polyscience MX15R-30-A11B) with water temperature set as low as 1°C will be used in the present study.
|
1 hour
|
Pressure algometer testing
大体时间:1 hour
|
Pressure algometer testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity).
In the pressure algometer test, the algometer is used to apply pressure to the skin until the pain can no longer be tolerated.
In the current study, we will utilize a device widely used in alogmeter pain research (Wagnder Force One Alogmeter FIPX).
|
1 hour
|
Brief Pain Inventory
大体时间:4 weeks
|
Measures: 1) pain severity= mean of items 3-6 (ranges from 0-10 with higher scores indicating greater pain severity), and 2) pain interference= mean of items 9A-9G (ranges from 0-10 with higher scores indicating greater pain interference).
|
4 weeks
|
Hospital Anxiety and Depression Scale
大体时间:4 weeks
|
Measures: 1) Anxiety (sum of 7 items; ranges from 0-21, with higher scores indicating greater anxiety), and 2) Depression (sum of 7 items; ranges from 0-21, with higher scores indicating greater depressive symptoms).
|
4 weeks
|
Mindful Attention Awareness Scale
大体时间:4 weeks
|
Measures mindfulness; mean of 15 items (ranges from 1 to 6, with higher scores indicating greater levels of mindfulness)
|
4 weeks
|
Schwartz Outcome Scale
大体时间:4 weeks
|
Measures general well-being; sum of 10 items (ranges from 0 to 60, with higher scores indicating greater well-being)
|
4 weeks
|
Toronto Mindfulness Scale-Decentering Subscale
大体时间:1 hour
|
Measures decentering; sum of 7 items (higher scores indicate greater levels of decentering)
|
1 hour
|
Opioid Compliance Checklist
大体时间:4 weeks
|
Measure misuse of opioid medications (scores range from 0 to 12, with higher scoring indicating greater misuse)
|
4 weeks
|
合作者和调查者
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.