Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety

Not Applicable

Completed

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)	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

Secondary Outcome Measures

Name	Time	Method
ED Utilization	Measured at 45 days, 3 months, 6 months, and 12 months	Return visits to the Emergency Department
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form	Measured at 45 days, 3 months, 6 months, and 12 months	quality of life
Cognitive and Affective Mindfulness Scale - Revised	Measured at 45 days, 3 months, 6 months, and 12 months	12-item measure (each scored 1-4) with total of 48. A higher score is consistent with greater mindfulness qualities.
Toronto Mindfulness Scale	Measured at 45 days, 3 months, 6 months, and 12 months	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.
Generalized Anxiety Disorder -7	Measured at 45 days, 6 months, and 12 months	Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe \> 15

Locations (1): IU Health Methodist Hospital
🇺🇸
Indianapolis, Indiana, United States
IU Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States