MINDFUL-PC for Portuguese Speakers Pilot #2 Study 2020 (Integrating Mindfulness Into the Patient-Centered Medical Home)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Mindfulness Training for Primary Care (Behavioral)
结局指标
主要结局
High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes
时间窗: 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.
次要结局
- Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)(Week 8)
- Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes(Week 9)
- Perceived Stress Scale (PSS-14)(Week 8)
- Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)(Week 8)