Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chest Pain
- Sponsor
- Indiana University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Paul Musey
Assistant Professor of Emergency Medicine
Indiana University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)
Time Frame: 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 Outcomes
- 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)