MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Comparative Effectiveness Trial of Chronic Illness Self-Management and Action Plan Initiation Among Primary Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Perceived Stress Scale
研究概览
简要总结
Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness introduction comparator on self-management of chronic illness and illness-related health behavior action plan initiation, as well as on measures related to anxiety, depression, and stress.
详细描述
This study builds on a pilot study that investigated the impact of Mindfulness Training for Primary Care on anxiety, depression, stress, and chronic illness self-management in primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system. The current comparative effectiveness randomized controlled trial takes place in a larger sample, and investigates the impact of a refined MTPC curriculum on specific aspects of self-regulation such as action plan initiation, while examining potential mechanisms of change, including self-efficacy, perceived control, mindfulness, self-compassion, emotion regulation, and body awareness. Participants randomized to MTPC are compared with participants who are randomized to a low-dose comparator condition and receive a 1-hour introduction to mindfulness with a referral to community mindfulness resources. Outcome assessments are conducted at baseline and study weeks 8-10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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.
- •Able to give written consent in English OR willing and able to provide consent and complete assessments through a professional language translator when necessary.
- •Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, or adjustment disorder related to chronic illness, pain, etc.).
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.
- •Previous enrollment or randomization of treatment in the present study within the 12 months.
- •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.
- •Lack of insurance coverage for group psychotherapy may preclude 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.
结局指标
主要结局
Perceived Stress Scale
时间窗: Baseline and week 8 (pre to post Intervention)
The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress).
Action Plan Initiation Survey (APIS-5)
时间窗: Weeks 8-10
The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable). For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.
Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
时间窗: Baseline and week 8 (pre to post Intervention)
The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).
Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
时间窗: Baseline and week 8 (pre to post Intervention)
The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).
次要结局
- Five Facet Mindfulness Questionnaire (FFMQ)(Baseline and week 8 (pre to post Intervention))
- Change in Self-Efficacy for Managing Chronic Disease (SECD-6)(Baseline and week 8 (pre to post Intervention))
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(Baseline and week 8 (pre to post Intervention))
- Perceived Control Questionnaire (PCQ)(Baseline and week 8 (pre to post Intervention))
- Difficulty in Emotion Regulation Scale (DERS)(Baseline and week 8 (pre to post Intervention))
- Self-Compassion Scale-Short Form (SCS-SF)(Baseline and week 8 (pre to post Intervention))