Mindfulness Influences on Self-regulation: Mental and Physical Health Implications -- Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Difficulty in Emotion Regulation Scale (DERS)
研究概览
简要总结
This study compares the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness comparator on self-regulation targets, specifically the primary outcome of emotion regulation. Secondary outcomes include sustained attention/response inhibition and interoceptive awareness. A secondary analysis will investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation.
详细描述
The current Phase 3 comparative effectiveness randomized controlled trial examines impact of MTPC on specific mechanisms of change such as emotion regulation (primary outcome), interoceptive awareness and sustained attention/response inhibition (secondary outcomes). This study will also investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation. Participants randomized to 8-week MTPC are compared with participants randomized to a low-dose mindfulness comparator condition, in which they 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. This study builds on the Phase 2 study, which demonstrated that Mindfulness Training for Primary Care enhanced chronic illness self-management action plan initiation among primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system.
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, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
- •Must have access to a smartphone that is compatible with the activity tracker application.
- •Must be willing to use the smartphone application and/or wear a wristband device every day during the study collection periods
- •Must be able to fill out the study questionnaires daily on a computer or compatible mobile device.
- •Must be willing to attend the two computer task sessions.
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.
- •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.
结局指标
主要结局
Difficulty in Emotion Regulation Scale (DERS)
时间窗: Week 8
The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation using a 5 point Likert scale. The scale assesses 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Subscales are summed and a lower total score represents a better outcome.
次要结局
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(Week 8)
- Sustained Attention to Response Task (SART)(Week 8)
- Action Plan Initiation Survey (APIS-5)(Weeks 8 - 10)
- Hypothetical Delay Discounting Task (HDDT)(Week 8)
- Heart Beat Detection Task (HBDT)(Week 8)
- Perceived Stress Scale (PSS-14)(Week 8)
- Self-Compassion Scale-Short Form (SCS-SF)(Week 8)
- Self-Efficacy for Managing Chronic Disease (SECD-6)(Week 8)
- Five Facet Mindfulness Questionnaire (FFMQ)(Week 8)
- Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)(Week 8)
- Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)(Week 8)
- Three Factor Eating Questionnaire -Revised 18 (TFEQ-R18) emotional eating subscale(Week 8)
- Food, Activity, and Sleep Tracking (FAST) Questionnaire(Weeks 7-8)
- Mobile Device Accelerometer-Based Activity(Weeks 7-8)