面向农村退伍军人：通过整体健康远程干预应用身心技能应对疼痛 - UH3 (RAMP)
2026年5月11日 更新者：Diana J. Burgess、Minneapolis Veterans Affairs Medical Center
覆盖农村退伍军人：运用基于整体健康的远程医疗干预进行身心技能疼痛管理
RAMP身心计划的目标是为退伍军人提供有助于管理疼痛的信息和工具。
该计划探讨身心之间的重要联系，以及如何利用这种特殊联系更有效地管理疼痛。
研究概览
详细说明
我们的长期目标是在退伍军人事务部（VA）改善农村患者的疼痛管理并减少阿片类药物使用。
为实现这一目标，我们将开展一项随机临床试验（RCT），以测试一种创新的多组分补充与整合干预措施——通过团体远程医疗提供的“触达农村退伍军人：运用身心技能进行疼痛管理的全人健康远程干预”（RAMP）——在VA医疗系统内改善农村退伍军人的疼痛管理、功能和福祉的效果。
本项目旨在应对为农村退伍军人实施有效非阿片类药物慢性疼痛管理干预的重大挑战。这些退伍军人承受着不成比例的全国疼痛负担，表现为更高的慢性疼痛率、更多的阿片类药物危害、更高的共病心理健康问题与药物滥用率，同时被开具更多阿片类药物，且更难获得基于证据、能满足其“全人”或生物心理社会需求的慢性疼痛护理。
RAMP项目战略性地整合了多种基于证据的补充与整合健康（CIH）自我管理策略，以应对农村退伍军人的生物心理社会需求并克服现有实施障碍。
该项目包含疼痛教育、正念练习、疼痛专项锻炼和认知行为策略，具有整体性和可扩展性。
研究类型
介入性
注册 (估计的)
500
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Diana Burgess, PhD
- 电话号码：612-467-1591
- 邮箱：diana.burgess@va.gov
研究联系人备份
- 姓名：Lee Cross, MPH
- 电话号码：612-629-7568
- 邮箱：lee.cross@va.gov
学习地点
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55417
- 招聘中
- Minneapolis VAMC
-
接触：
- Diana Burgess, PhD
- 电话号码：612-467-1591
- 邮箱：diana.burgess@va.gov
-
接触：
- Lee Cross, MPH
- 电话号码：612-629-7568
- 邮箱：lee.cross@va.gov
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
(1) 年龄18岁或以上；(2) 根据美国卫生服务研究管理局标准定义的农村居民；(3) 慢性疼痛，基于过去2年内电子健康记录中同一诊断类别下至少间隔90天的两个符合资质的疼痛诊断；(4) 自我报告在过去3个月内至少大多数日子存在疼痛；(5) 简明疼痛量表干扰分量表得分≥4/10；(6) 拥有可接入互联网的设备；(7) 愿意参与干预特定程序（例如，远程在线参加会议）；(8) 电子健康记录中列有电子邮件地址。
排除标准：
排除标准：(1) 严重且控制不佳的精神疾病或物质使用障碍（通过病历审查确定）；(2) 本研究咨询小组的活跃成员；(3) 已参与另一项疼痛相关研究；(4) 已参与类似研究；(5) 已参与类似的、为期数周、多模式、有引导的补充与整合健康计划。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：干涉
|
RAMP 是一项为期 9 周的计划，包含每周一次的在线小组会议（每次 90 分钟），配有预先录制的专家主导的教育视频、身心技能培训和实践，以及引导式讨论。
|
|
无干预：日常护理
|
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 |
|---|---|---|
|
Pain interference
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using the Brief Pain Inventory (BPI) interference score.
Minimum value: 0. Maximum value: 10.
Higher scores indicate worse functioning.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain intensity
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using the Brief Pain Inventory (BPI) intensity score.
Minimum value: 0. Maximum value: 10.
Higher scores indicate more severe pain.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Pain impact
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using the Graded Chronic Pain Scale-Revised (GCPS-R), a six item scale developed to differentiate mild, bothersome, and high-impact chronic pain.
Two questions to identify chronic pain and high impact chronic pain; frequency of pain during the prior 3 months and frequency of limitation in activities in the prior 3 months.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Quality of life
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using the World Health Organization (WHO) 2-item measure which measures quality of life and satisfaction with health on a 1 to 5 scale.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Quality of life
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using the Euro Quality of Life scale, a 5 section questionnaire to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Physical functioning
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Using the PROMIS Physical functioning 6-item short form v2.0 which measures difficulty doing household activities and agreement with statements on health limitations in physical activities on a 1 to 5 scale.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Sleep disturbance
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using PROMIS 6-item short form v1.0 which measures sleep quality on a 1 to 5 scale from very poor to very good in addition to agreement with statements on sleep quality on a 1 to 5 scale.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Sleep duration
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Participants self-report their hours of sleep per night in the past month.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Fatigue
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
The PROMIS fatigue 4-item short form v1.0, which measures fatigue over the past 7 days.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Participation in Social Roles and Activities
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using the PROMIS 4-item short form v2.0 which measures frequency of trouble doing activities for leisure, work, or with family or friends on a 1 to 5 scale.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Anxiety
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Anxiety will be measured using the Generalized Anxiety Disorder-2 survey (GAD-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Depression
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Depression will be measured using the Patient Health Questionnaire-2 (PHQ-2) which includes 2 questions that are summed for a total score that can range from 0 to 6.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Post Traumatic Stress Disorder (PTSD)
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using the Primary Care PTSD Screen for DSM-5, which asks whether the participant has had exposure to a traumatic event, and if yes, asks 5 follow-up yes/no question regarding experiences in the past month.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Overall improvement
大体时间：Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.
|
Overall improvement will be assessed with the Patient Global Impression of Change (PGIC) which has participants rate their overall change from very much worse to very much improved on a 7-point scale.
|
Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.
|
|
Percentage of participants self-reporting opioid medication use
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Participant self report of opioid medication use.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Substance use
大体时间：Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
Measured using the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) survey.
The TAPS is comprised of a 4-item screen for substance use.
|
Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.
|
|
Adverse events
大体时间：Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.
|
Participant self-report of any new or worsening health issue while participating in the study.
Participants will also be asked to report potential side effects by choosing from a list of known potential risks of exercise and mindfulness interventions.
|
Average over 6 months of follow-up, with assessments at 10 weeks and 6 months.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Roni Evans, DC, PhD, MS、University of Minnesota
- 首席研究员：Katherine Hadlandsmyth, PhD、University of Iowa
- 首席研究员：Diana Burgess, PhD、Minneapolis Veterans Affairs Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年4月12日
首先提交符合 QC 标准的
2026年4月14日
首次发布 (实际的)
2026年4月21日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 4UH3NR020929-02 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
研究数据将提交至美国国家心理健康研究所（NIMH）数据档案库（NDA）。
人口统计学和临床结局指标将通过美国国立卫生研究院（NIH）/HEAL CDE存储库中的通用数据元素（CDEs）进行收集和共享。
变量命名和允许的响应值将根据CDEs数据字典规范进行统一。
向研究界公开的文档将包括：1. 研究方案；2. 信息表（根据免除知情同意文件要求提供）；3. 数据收集表/病例报告表；4. 数据字典。
IPD 共享时间框架
已发表手稿中包含的科学数据将在发表时提供；所有其他生成的科学数据将在奖项结束前与NDA存储库共享。
IPD 共享访问标准
本研究的出版物将在发表之日起一年内通过美国国家医学图书馆PubMed Central网站向公众提供。
研究项目团队和PRISM/协作项目协调中心将共同努力，提供去识别化或有限的数据集供公众使用。
在可行的情况下，将根据数据使用协议（DUA）创建和共享有限数据集（LDS），该协议适当限制数据集的使用，并禁止接收方识别或重新识别（或采取步骤识别或重新识别）数据集中包含的任何个人。
除非获得VA隐私官员批准，否则不会共享任何PHI或VA敏感数据。
只有经ACOS与MPIs协商批准的研究人员才能访问个人可识别数据。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.