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

Indiana University

Status: Completed

Conditions: Mindfulness; Chest Pain; Anxiety

Treatments: Behavioral: MBSR Referral; Other: Usual Care Referral

Study type: Interventional

Funder types: Other

Identifiers

NCT03365375

VFR-447 Musey

Details and patient eligibility

About

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).

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Usual Care Referral

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care Referral

MBSR Referral

Experimental group

Description:

Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.

Treatment:

Other: Usual Care Referral

Behavioral: MBSR Referral