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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
Referral to PCP or Psychiatry
IU Health Methodist Hospital
Indianapolis, Indiana, United States
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)
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
Time frame: Measured at 3 months
Generalized Anxiety Disorder -7
Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe \> 15
Time frame: Measured at 45 days, 6 months, and 12 months
ED Utilization
Return visits to the Emergency Department
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form
quality of life
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Cognitive and Affective Mindfulness Scale - Revised
12-item measure (each scored 1-4) with total of 48. A higher score is consistent with greater mindfulness qualities.
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Toronto Mindfulness Scale
13-item state-mindfulness measure that has two sub-scales: Curiosity, 6 items, subscale score ranging from 0-24, and Decentering, 7 items, with a subscale score ranging from 0-28.
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
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