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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-28

Study Completion Date

2020-09-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chest Pain Anxiety Mindfulness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care Referral

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.

Group Type ACTIVE_COMPARATOR

Usual Care Referral

Intervention Type OTHER

Referral to PCP or Psychiatry

MBSR Referral

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

Group Type EXPERIMENTAL

MBSR Referral

Intervention Type BEHAVIORAL

Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.

Usual Care Referral

Intervention Type OTHER

Referral to PCP or Psychiatry

Interventions

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MBSR Referral

Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.

Intervention Type BEHAVIORAL

Usual Care Referral

Referral to PCP or Psychiatry

Intervention Type OTHER

Other Intervention Names

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MBSR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No