MINDFUL-PC for Portuguese Speakers Pilot Study 2020
2021年2月9日 更新者：Cambridge Health Alliance
MINDFUL-PC for Portuguese Speakers Pilot #2 Study 2020 (Integrating Mindfulness Into the Patient-Centered Medical Home)
The study evaluates the effects of the Mindfulness Training for Primary Care (MTPC) Portuguese-adapted version on heart rate variability during a demanding cognitive task.
The study also evaluates the effects on mental health, quality of life, self-regulation and behavior outcomes.
The study will also complete the MTPC cultural adaptation process for Brazilian culture.
研究概览
详细说明
This single-arm, pre-post, non-randomized, unblinded, pilot trial evaluates the effects of Mindfulness Training for Primary Care (MTPC) Portuguese-adapted version on heart rate variability during a demanding cognitive task, i.e., Sustained Attention to Response Task (SART).
Secondary aims are the following: 1) to measure pre/post outcomes for a) mental health (anxiety, depression, stress); b) quality of life; c) self-regulation (self-compassion, mindfulness, interoceptive awareness, difficulties in emotion regulation); and to determine the rate of d) chronic disease self-management action plan initiation; and 2) to complete the MTPC cultural adaptation for Brazilian culture through a) Satisfaction and Suggestions Survey; and b) Interviews of MTPC Group Leaders about their experience teaching the program Portuguese-adapted version.
研究类型
介入性
注册 (实际的)
15
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
-
-
Massachusetts
-
Somerville、Massachusetts、美国、02143
- Cambridge Health Alliance
-
-
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
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Current CHA patient with an enrolled CHA primary care doctor.
- CHA patients 18 years of age and older.
- Able to tolerate and participate in interviews and engage in all procedures.
- Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
- Must be able to fill out the study questionnaires on a computer or compatible mobile device.
- Must be willing to attend the two computer task sessions.
- Able to give written consent in Portuguese
Exclusion Criteria:
- Any cognitive impairment that precludes informed consent.
- Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others.
- Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment.
- Behaviors that may cause disruption to a mindfulness group.
- Patients with symptoms of psychosis, thought disorder, and/or severe mental illness, including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of major depressive disorder.
- Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from participation in groups.
- Patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities.
- Patients with highly unstable medical problems that put them at a high risk of hospitalization.
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：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 |
|---|---|
|
实验性的：Mindfulness Training for Primary Care
Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers
|
MTPC 是一项基于转诊、可报销的为期 8 周的计划，由以患者为中心的医疗家庭综合行为临床医生提供团体心理治疗，或由初级保健提供者提供为期 8 周的初级保健小组访问。
MTPC 小组为期 8 周，每次 2 小时，周末有 7 小时的静默练习。
MTPC 强调以正念为导向的自我调节、慢性病自我管理和健康行为改变的技能。
所有参与者都在第 7 周内完成一项行动计划。在前八周内，每两周会打电话给参与者一次 5-10 分钟的参与电话，重点是帮助参与者培养与研究人员的关系，为参与者提供提问的场所，并支持参与者在完成学习访问时。
|
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 |
|---|---|---|
|
High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes
大体时间：Week 9
|
High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes will be measured using Biostamp nPoint® medical device.
During SART participants complete a computerized test measuring sustained attention and response inhibition.
They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer.
|
Week 9
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
感知压力量表 (PSS-14)
大体时间：第 8 周
|
感知压力量表 (PSS-14)（14 项）衡量生活中的压力程度。
项目旨在评估一个人发现自己的生活有多么超载、不可预测和无法控制。
每个项目都按照 5 点李克特量表进行评分，从 0（从不）到 4（非常频繁）。
|
第 8 周
|
|
患者报告结果测量信息系统 - 焦虑简表 (PROMIS-ASF)
大体时间：第 8 周
|
患者报告结果测量信息系统 - 焦虑简表 8a (PROMIS-ASF) 是一个 8 项量表，用于评估患者报告的焦虑健康状况。
PROMIS 仪器由美国国立卫生研究院 (NIH) 资助，用于可靠有效地测量患者报告的临床研究和实践结果。
参与者被要求以 1（从不）到 5（总是）的 5 分制来评价他们在过去 7 天内对项目的体验。
|
第 8 周
|
|
患者报告结果测量信息系统 - 抑郁简表 (PROMIS-DSF)
大体时间：第 8 周
|
患者报告结果测量信息系统 - 抑郁简表 8a (PROMIS-DSF) 是一个 8 项量表，用于评估患者报告的抑郁健康状况。
PROMIS 仪器由美国国立卫生研究院 (NIH) 资助，用于可靠有效地测量患者报告的临床研究和实践结果。
参与者被要求以 1（从不）到 5（总是）的 5 分制来评价他们在过去 7 天内对项目的体验。
|
第 8 周
|
|
Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes
大体时间：Week 9
|
Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes will be measured using Biostamp nPoint® medical device.
During SART participants complete a computerized test measuring sustained attention and response inhibition.
They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer.
|
Week 9
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
情绪调节困难量表（DERS）
大体时间：第 8 周
|
情绪调节困难 (DERS) 量表是一个包含 36 个项目的自我报告量表，旨在使用 5 点李克特量表评估情绪失调。
该量表评估了情绪失调的 6 个方面：不接受情绪反应、难以参与目标导向行为、冲动控制困难、缺乏情绪意识、情绪调节策略的使用受限以及缺乏情绪清晰度。
子量表相加，总分越低代表结果越好。
|
第 8 周
|
|
内感受意识的多维评估 (MAIA)
大体时间：第 8 周
|
内感受意识的多维评估 (MAIA) 是一个包含 32 个项目的自我报告量表，旨在评估内感受和内感受意识的多个方面。
6 点李克特量表（范围从 0-6）评估内感受意识的 8 个方面：注意、不分心、不担心、注意力调节、情绪意识、自我调节、身体倾听和信任。
子量表是平均的，总分越高代表结果越好。
|
第 8 周
|
|
五面正念问卷 (FFMQ)
大体时间：第 8 周
|
五方面正念问卷 (FFMQ) 是一个包含 39 个项目的量表，它检查了代表当前正念实证概念各个方面的五个因素。
这五个方面包括：“观察、描述、有意识地行动、不判断内在体验、不对内在体验做出反应。”
参与者根据李克特式量表对每个项目的同意程度进行评分，范围从 1（从不或很少为真）到 5（非常经常或总是为真），分数越高表示正念体验越高。
|
第 8 周
|
|
High-Frequency power (HF) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks
大体时间：Week 9
|
High-Frequency power (HF) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks will be measured using Biostamp nPoint® medical device.
During SART participants complete a computerized test measuring sustained attention and response inhibition.
They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer.
Relationship between HF-HRV and SART performance will be evaluated and the effect of over time during the demanding SART task will also be evaluated.
|
Week 9
|
|
Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks
大体时间：Week 9
|
Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks will be measured using Biostamp nPoint® medical device.
During SART participants complete a computerized test measuring sustained attention and response inhibition.
They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer.
Relationship between RMSSD and SART performance will be evaluated and the effect of over time during the demanding SART task will also be evaluated.
|
Week 9
|
|
Action Plan Initiation Survey (APIS-5)
大体时间：Week 9
|
Patient self-reported Action Plan Initiation is based on two-item in the APIS-5 self-report survey in which patients are asked to list their action plan SMART goal, if they met the goal and how much control they had over meeting the goal.
The main outcome is a single-item response determining whether they met or did not meet the goal using a 7-point Likert scale (ranging from 1-7) with scores >=5 representing self-reported initiation of the goal.
|
Week 9
|
|
World Health Organization Quality of Life- BREF (WHOQOL-BREF)
大体时间：Week 8
|
The World Health Organization has developed a quality of life instrument, the WHOQOL, which captures many subjective aspects of quality of life.
The WHOQOL-BREF is a WHOQOL shorter version, comprises 26 items that produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment.
It also includes one facet on overall quality of life and general health.
|
Week 8
|
|
Self-Compassion Scale (SCS)
大体时间：Week 8
|
The Self-Compassion Scale is composed by 26 items measuring six components of self-compassion: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification.The items are rated on a five-point response scale ranging from 1 (almost never) to 5 (almost always).
|
Week 8
|
|
Satisfaction Survey
大体时间：Week 8
|
Satisfaction Survey is an 18-item survey contains two parts.
First is a series of 12 questions scored on a 5-point Likert scale from 1 (Strongly Disagree/Poor) to 5 (Strongly Agree/Excellent), with statements such as "I found this program helpful."
Next is a series of six open-ended questions in which patients enter a written response to statements including "The most important thing I learned during this program."
|
Week 8
|
|
Suggestions Survey
大体时间：Week 8
|
The Suggestions Survey consist of 4 questions focusing on the intervention cultural aspects.
|
Week 8
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gawande R, To MN, Pine E, Griswold T, Creedon TB, Brunel A, Lozada A, Loucks EB, Schuman-Olivier Z. Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial. J Gen Intern Med. 2019 Feb;34(2):293-302. doi: 10.1007/s11606-018-4739-5. Epub 2018 Dec 3.
- Gawande R, Pine E, Griswold T, Creedon T, Vallejo Z, Rosenbaum E, Lozada A, Schuman-Olivier Z. Insurance-Reimbursable Mindfulness for Safety-Net Primary Care Patients: A Pilot Randomized Controlled Trial. Mindfulness (N Y). 2019 Sep;10(9):1744-1759. doi: 10.1007/s12671-019-01116-8. Epub 2019 Mar 18.
- Trombka M, Creedon TB, Demarzo M, Cuoco LT, Smith L, Oxnard AC, Rozembaque AT, Hirayama MS, Moreno NB, Comeau A, Gawande R, Griswold T, Cook BL, Rocha NS, Schuman-Olivier Z. Mindfulness Training for Primary Care for Portuguese-Speaking Immigrants: A Pilot Study. Front Psychiatry. 2021 Sep 9;12:664381. doi: 10.3389/fpsyt.2021.664381. eCollection 2021.
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)
2020年1月21日
初级完成 (实际的)
2020年4月10日
研究完成 (实际的)
2020年4月10日
研究注册日期
首次提交
2020年2月11日
首先提交符合 QC 标准的
2020年2月11日
首次发布 (实际的)
2020年2月13日
研究记录更新
最后更新发布 (实际的)
2021年2月11日
上次提交的符合 QC 标准的更新
2021年2月9日
最后验证
2021年2月1日
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.