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

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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

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

Trial documents
2

Trial contacts and locations

0

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Central trial contact

Paul I Musey, MD, MS

Data sourced from clinicaltrials.gov

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