针对社区老年黑人群体慢性疼痛-抑郁共病问题的正念认知疗法;《静心专注》开放试点
2026年8月16日 更新者:Tony V. Pham, MD、Massachusetts General Hospital
社区老年黑人群体中慢性疼痛-抑郁共病问题的正念认知疗法;《静心专注》开放试点研究
本临床试验的目标是试点一项针对慢性疼痛和抑郁的正念认知疗法的适应性研究。 它旨在在后续充分把握的随机对照试验中回答的主要问题是:
- 针对老年黑人成年人的正念认知疗法适应性研究能否改善生活质量?
- 与传统的健康促进计划相比,适应性正念认知疗法是否能在更大程度上减少疼痛干扰?
研究概览
详细说明
在老年黑人群体中,慢性疼痛与抑郁症共病现象普遍存在,这种共病会加剧身体和情感功能障碍。
获得循证非药物管理的机会有限。
正念认知疗法(MBCT)是一种基于证据的非药物干预措施,可应对老年黑人群体中的慢性疼痛与抑郁症共病问题,但需要进行调整以适应特定需求。
本研究将评估“静心专注”的可行性、可接受性和可信度,这是针对社区老年黑人群体慢性疼痛与抑郁症共病的MBCT文化适应性方案。
研究类型
介入性
注册 (实际的)
12
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。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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-
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
参与者纳入标准
- 老年人(年龄≥50岁)
- 所有认同一个或多个源自非洲任何黑人种族群体的国籍或族裔群体的个体
- 肌肉、关节、骨骼或相关软组织疼痛(NRS>4)持续超过3个月
- 抑郁(PHQ-9评分5-14分)
- 英语流利/识字
- 能够并愿意通过面对面和视频方式参与
- 筛查前至少6周内抗抑郁药物的类型或剂量未发生变化
- 愿意提供知情同意并遵守方案的所有要求
参与者排除标准
- 中度严重或严重抑郁症状(PHQ-9≥15分)
- 当前物质滥用/依赖
- 显著认知障碍
- 接受过超过8次认知行为治疗的历史
- 有正念训练史或每月接受超过一次咨询的历史
- 有精神病病史或当前诊断
- 当前有自杀意念(PHQ-9第9项或在筛查期间报告)或过去90天内有过自伤行为
- 当前参与另一项行为临床试验
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:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:基于正念的认知疗法
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The delivered intervention is mindfulness-based cognitive therapy adapted for the chronic pain and depression among older Black adults.
Mindfulness-based cognitive therapy (MBCT) is a structured psychotherapy that integrates mindfulness practices with cognitive behavioral therapy techniques.
This adapted MBCT is delivered as an 8-week group-based program with each weekly session lasting about 1 hour.
Sessions occur once per week, supplemented by daily home practice of 40-60 minutes, 6 days a week, involving guided meditations, body scans, and mindful activities to reinforce skills.
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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 |
|---|---|---|
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客户满意度问卷
大体时间:在治疗第8周结束时给药。
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客户满意度问卷3项简化版(CSQ-3)的评分方式是对其三个核心项目的回答进行求和。
该问卷包含经实证筛选的测量服务满意度关键维度的项目,每项均采用4点李克特量表评分(1=最低满意度至4=最高满意度,必要时调整方向性)。
总分范围为3至12分,分值越高表示满意度越高;无需反向计分或计算子量表。
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在治疗第8周结束时给药。
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The Credibility and Expectancy Questionnaire
大体时间:Baseline (at enrollment, prior to intervention initiation).
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The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure assessing treatment credibility (items 1-3) and expectancy (items 4-6).
Items 1-3 and 5 are rated 0 (not at all credible/logical) to 9 (extremely credible/logical), while items 4 and 6 are rated 0% to 100%; subscale scores are standardized and summed (credibility: 3-27 raw equivalent; expectancy similar), with total scores ranging 6-54 after standardization, where higher scores indicate greater credibility and positive outcome expectancy (better outcome).
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Baseline (at enrollment, prior to intervention initiation).
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Modified Patient Global Impression of Change
大体时间:At end of 8 week program (post test) and again at 3 month follow up visit.
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The Modified Patient Global Impression of Change (mPGIC) adapts the standard single-item Patient Global Impression of Change (PGIC), a validated patient-reported outcome measure of overall perceived change since intervention, by assessing change across six specific domains.
Each domain uses a single ordinal item rated on a 7-point scale, coded from 1 = Very Much Improved to 7 = Very Much Worse.
Lower scores indicate greater perceived improvement.
Domains include coping strategies, physical activity, social activity, level of stress, memory and thinking, and pain, and are analyzed separately.
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At end of 8 week program (post test) and again at 3 month follow up visit.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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数字评分量表
大体时间:从入组至治疗结束(8周)后3个月。
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疼痛强度数值评分量表(NRS)是一个11分制量表,范围从0分(无疼痛)到10分(可想象的最严重疼痛),用于评估过去一周的平均疼痛程度。
分数越高表示疼痛强度越大(结果更差),分数越低表示疼痛越轻(结果更好);为单项总分。
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从入组至治疗结束(8周)后3个月。
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PROMIS 焦虑量表
大体时间:从入组到治疗结束8周后的3个月
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PROMIS 简表 V1.0 - 情绪困扰焦虑 8a(PROMIS Anxiety SF 8a v1.0)是一项包含8个条目的患者报告结局测量工具,用于评估过去7天内自我报告的焦虑症状,包括恐惧、紧张、担忧、恐惧感以及感到紧绷或不安。
每个条目采用5点李克特反应量表:从未(1)、很少(2)、有时(3)、经常(4)或总是(5)。 原始总分范围从8分(焦虑程度最低,最佳结果)到40分(严重焦虑,最差结果);这些分数通过评分表转换为T分数(在美国人群中均值=50,标准差=10),其中较高的T分数表示焦虑严重程度更高。 不计算子量表;总分反映整体焦虑困扰。 8a简表的T分数范围:28-82。 |
从入组到治疗结束8周后的3个月
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PROMIS Physical Function
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks
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The PROMIS Short Form V2.0 - Physical Function 8B (PROMIS PF 8B v2.0) is an 8-item patient-reported outcome measure assessing self-reported capability in physical activities, including upper extremity function (e.g., hand/arm tasks), lower extremity function (e.g., walking), central body function, and daily activities.
It uses a 5-point Likert response scale per item: Without any difficulty (5), With little difficulty (4), With some difficulty (3), With much difficulty (2), or Unable to do/Cannot do (1).
Raw total scores range from 8 (severe difficulty, worst outcome) to 40 (no difficulty, best outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate better physical function.
No subscales are computed; the total score reflects overall physical function.
The T-score range for the PROMIS SF V1.2 is 10-65.
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From enrollment to 3 months from the end of treatment at 8 weeks
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PROMIS Depression
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks
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The PROMIS Short Form V1.0 - Emotional Distress Depression 8b (PROMIS Depression SF 8b v1.0) is an 8-item patient-reported outcome measure assessing self-reported depressive symptoms over the past 7 days, including feelings of worthlessness, helplessness, sadness, failure, depression, unhappiness, and hopelessness.
It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5).
Raw total scores range from 8 (minimal depression, best outcome) to 40 (severe depression, worst outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater depression severity.
No subscales are computed; the total score reflects overall depressive distress.
T-score range: 42-84.
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From enrollment to 3 months from the end of treatment at 8 weeks
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PROMIS Emotional Support
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks.
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The PROMIS Short Form V2.0 - Emotional Support 8a (PROMIS Emotional Support SF 8a v2.0) is an 8-item patient-reported outcome measure assessing perceived availability of supportive interpersonal relationships over the past 7 days, including listening, confiding, appreciation, understanding, and trust.
It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5).
Raw total scores range from 8 (minimal support, worst outcome) to 40 (strong support, best outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater emotional support.
No subscales are computed; the total score reflects overall perceived support.
T-score range: 25-75 for the 8a short form.
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From enrollment to 3 months from the end of treatment at 8 weeks.
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Measure of Current Status Part A
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks
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The Measure of Current Status Part A (MOCS-A) is a self-report questionnaire that measures ability to manage stress.
The Measure of Current Status Part A (MOCS-A) comprises 13 items rated 0 (cannot do at all) to 4 (extremely well), summed for total score 0-52, with four subscales: relaxation, tension awareness, assertiveness, coping confidence (higher total/subscale scores indicate better stress management ability, better outcome).
Each item is rated on a 5-point Likert scale where 0 = "I cannot do this at all" and 4 = "I can do this extremely well," with higher scores reflecting greater confidence in coping skills.
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From enrollment to 3 months from the end of treatment at 8 weeks
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Cognitive and Affective Mindfulness Scale-Revised
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks
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The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a 12-item scale rated 1 (rarely/not at all) to 4 (almost always), total score summed 12-48 (higher scores indicate greater mindfulness ability, better outcome); unidimensional total score.
Scoring: Items 2, 6, and 7 are reverse-scored.
After appropriate reversals, sum values for items 1-12.
Higher values reflect greater mindful qualities.
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From enrollment to 3 months from the end of treatment at 8 weeks
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Chronic Pain Acceptance Questionnaire
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks
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The Chronic Pain Acceptance Questionnaire (CPAQ) sums 20 items rated 0 (never true) to 6 (always true) for total raw score 0-120, with two subscales: Activity Engagement (0-66) and Pain Willingness (0-54), both/totals higher indicating greater pain acceptance (better outcome).
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From enrollment to 3 months from the end of treatment at 8 weeks
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Pain Self-Efficacy Questionnaire
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks
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The Pain Self-Efficacy Questionnaire (PSEQ) consists of 10 items rated 0 (not at all confident) to 6 (completely confident), summed for total 0-60.
Higher scores indicate greater self-efficacy despite pain (better outcome); single total score.
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From enrollment to 3 months from the end of treatment at 8 weeks
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Pain Catastrophizing Scale
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks
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The Pain Catastrophizing Scale (PCS) sums 13 items rated 0 (not at all) to 4 (all the time) for total 0-52, with subscales: Rumination (0-16), Magnification (0-12), Helplessness (0-24); higher scores indicate greater catastrophizing (worse outcome).
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From enrollment to 3 months from the end of treatment at 8 weeks
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Tampa Kinesiophobia Scale
大体时间:From enrollment to 3 months from the end of treatment at 8 weeks
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The Tampa Scale of Kinesiophobia (TSK-17) sums 17 items rated 1 (strongly disagree) to 4 (strongly agree), with reverse on items 4, 8, 12, and 16.
Total score range: 17-68 (higher scores greater kinesiophobia/fear of movement, worse outcome).
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From enrollment to 3 months from the end of treatment at 8 weeks
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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:Tony V Pham, MD, MScGH、Massachusetts General Hospital
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)
2024年11月15日
初级完成 (实际的)
2025年7月22日
研究完成 (实际的)
2025年7月22日
研究注册日期
首次提交
2026年1月8日
首先提交符合 QC 标准的
2026年1月10日
首次发布 (实际的)
2026年1月13日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月16日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 2024P001995
- K23AT012363 (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
试验期间收集的所有个体参与者数据。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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.