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

Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot 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).

Study Overview

• Status: Completed
• Conditions: Chest Pain; Anxiety; Mindfulness
• Intervention / Treatment: Other: Usual Care Referral; Behavioral: MBSR Referral

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul I Musey, MD, MS; Phone Number: 317-880-3900; Email: pmusey@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)	Difference in GAD-7 score at enrollment compared to assessment at 3 months. 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
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
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form	quality of life	Measured at 45 days, 3 months, 6 months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire - 8 (Depression)	Measure of current depression: None - Minimal depression (0 to 4), Mild depression (5 to 9), Moderate depression (10 to 14), Moderately severe depression (15 to 19), Severe depression (20 to 24)	Measured at 45 days, 3 months, 6 months, and 12 months
Healthcare Utilization	Visits to care professionals other then the ED	Measured at 45 days, 3 months, 6 months, and 12 months
PTSD Screener	4 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a PTSD.	Measured at 45 days, 3 months, 6 months, and 12 months
Panic Screener	5 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a panic disorder.	Measured at 45 days, 3 months, 6 months, and 12 months
Social Anxiety Screener	3 item measure (each scored 1-4) with total possible score of 12. Higher score associated with higher social anxiety	Measured at 45 days, 3 months, 6 months, and 12 months
Patient Health Questionnaire - 15 (Physical Symptoms)	Somatic symptom severity: Minimal 0-4, Low 5-9, Medium 10-14, High 15-30	Measured at 45 days, 3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University Health
• Investigators: Principal Investigator: Paul I Musey, MD, MS, Indiana University School of Medicine, Department of Emergency Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Mindfulness; Emergency Service, Hospital; Chest Pain
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Chest Pain
• Other Study ID Numbers: VFR-447 Musey

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data from the clinical study report and the study protocol will be shared upon request.
• IPD Sharing Time Frame: Data will be available for 5 years after study completion date.
• IPD Sharing Access Criteria: email PI at pmusey@iu.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No