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

Study Overview
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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).

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.

Official Title
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Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot Randomized Trial

Conditions
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Chest Pain, Anxiety, Mindfulness

Intervention / Treatment
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* Behavioral: MBSR Referral
* Other: Usual Care Referral


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Referral<br>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. | Other: Usual Care Referral<br>* Referral to PCP or Psychiatry<br>|
| Experimental: MBSR Referral<br>Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP. | Behavioral: MBSR Referral<br>* Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.<br>* Other names: MBSR;Other: Usual Care Referral<br>* Referral to PCP or Psychiatry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder -7 | Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15 | Measured at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder -7 | Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15 | Measured at 45 days, 6 months, and 12 months | 
| ED Utilization | Return visits to the Emergency Department | Measured at 45 days, 3 months, 6 months, and 12 months | 
| PROMIS Global Short Form | quality of life | Measured at 45 days, 3 months, 6 months, and 12 months | 
| Cognitive and Affective Mindfulness Scale - Revised | 12-item measure (each scored 1-4) with total of 48. A higher score is consistent with greater mindfulness qualities. | Measured at 45 days, 3 months, 6 months, and 12 months | 
| Toronto Mindfulness Scale | 13-item state-mindfulness measure that has two sub-scales: Curiosity, 6 items, subscale score ranging from 0-24, and Decentering, 7 items, with a subscale score ranging from 0-28. | Measured at 45 days, 3 months, 6 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest Pain, Anxiety, Mindfulness, Emergency Service, Hospital