Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
| Status: | Recruiting |
|---|---|
| Conditions: | Angina, Anxiety |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 7/27/2018 |
| Start Date: | January 28, 2018 |
| End Date: | July 1, 2019 |
| Contact: | Paul I Musey, MD, MS |
| Email: | pmusey@iu.edu |
| Phone: | 317-880-3900 |
Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot Randomized Trial
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).
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.
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.
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
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