Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)
研究概览
简要总结
This Emergency Department based study investigates the feasibility and effectiveness of a mindfulness based stress reduction (MBSR) training program referral for patients with chest pain at low risk for acute coronary syndrome but associated with anxiety. Outcomes assessed for eligible patients randomized to MBSR vs. usual care include mental health (longitudinal Generalized Anxiety Disorder - 7 (GAD-7) scores), quality of life (PROMIS Global Short Form), and ED resource utilization (return Emergency Department (ED) visits).
详细描述
To determine the effect of an MBSR training program for patients with low-risk chest pain associated with anxiety on mental health (longitudinal GAD-7 scores, quality of life (PROMIS Global Short Form), and ED resource utilization (return ED visits). The working hypothesis is that early referral to MBSR will help patients better regulate their thoughts, feelings, and bodily sensations related to their anxiety symptoms and have a significant positive effect on patient-centered outcomes such as mental health, quality of life as well as decreased ED resource utilization. To this end the investigators will randomize patients identified via a two step process (HEART Score <4 and GAD-7 score > 9 to usual care referrals versus MBSR. The investigators will then follow these participants for outcomes including change in GAD-7 scores, PROMIS Global Short Form, ED utilization among other outcomes at 6 weeks, 3 months, 6 months, and 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Chief complaint of chest pain
- •HEART Score of 0-3 indicating Major Adverse Cardiac Events (MACE) risk equivalent to ≤2%
- •GAD-7 score > or = 10
排除标准
- •Age <18 or ≥ 71
- •Chief complaint of anxiety, panic, or similar
- •Prior personal acute coronary syndrome (ACS) history (known at time of provider interview)
- •Previous enrollment in the study
- •Traumatic injury to the chest
- •Suicidal ideation or active psychosis or behavioral issues requiring psychiatric monitoring
- •Hemodynamic instability
- •Non-English speaking
- •Potential issues affecting follow up: Prisoners, homeless patients, out-of-town residences
研究组 & 干预措施
Usual Care Referral
Subjects will be referred for primary care provider (PCP) follow up and/or to psychiatry for further management and treatment of elevated anxiety levels according to standard of care.
干预措施: Usual Care Referral (Other)
MBSR Referral
Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.
干预措施: MBSR Referral (Behavioral)
MBSR Referral
Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.
干预措施: Usual Care Referral (Other)
结局指标
主要结局
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)
时间窗: Measured at 3 months
Difference in GAD-7 score at enrollment compared to assessment at 3 months. Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe \> 15
次要结局
- ED Utilization(Measured at 45 days, 3 months, 6 months, and 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form(Measured at 45 days, 3 months, 6 months, and 12 months)
- Generalized Anxiety Disorder -7(Measured at 45 days, 6 months, and 12 months)
- Cognitive and Affective Mindfulness Scale - Revised(Measured at 45 days, 3 months, 6 months, and 12 months)
- Toronto Mindfulness Scale(Measured at 45 days, 3 months, 6 months, and 12 months)
研究者
Paul Musey
Assistant Professor of Emergency Medicine
Indiana University