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

NCT03365375 | Completed Results DMC

• 1 other identifier: VFR-447 Musey
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chest Pain; Anxiety; Mindfulness

Keywords

Chest Pain; Anxiety; Mindfulness; Emergency Service, Hospital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Generalized Anxiety Disorder -7

  Measured at 45 days, 6 months, and 12 months

• ED Utilization

  Measured at 45 days, 3 months, 6 months, and 12 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form

  Measured at 45 days, 3 months, 6 months, and 12 months

• Cognitive and Affective Mindfulness Scale - Revised

  Measured at 45 days, 3 months, 6 months, and 12 months

• Toronto Mindfulness Scale

  Measured at 45 days, 3 months, 6 months, and 12 months

Other Outcomes (6)

• Patient Health Questionnaire - 8 (Depression)

  Measured at 45 days, 3 months, 6 months, and 12 months

• Patient Health Questionnaire - 15 (Physical Symptoms)

  Measured at 45 days, 3 months, 6 months, and 12 months

• Healthcare Utilization

  Measured at 45 days, 3 months, 6 months, and 12 months

Study Arms (2)

Usual Care Referral

ACTIVE COMPARATOR

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

MBSR Referral

EXPERIMENTAL

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

Behavioral: MBSR Referral; Other: Usual Care Referral

Interventions

MBSR Referral BEHAVIORAL

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

Also known as: MBSR

MBSR Referral

Usual Care Referral OTHER

Referral to PCP or Psychiatry

MBSR Referral; Usual Care Referral

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Chest Pain; Anxiety Disorders; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Paul Musey
• Organization: Indiana University

pmusey@iu.edu

317-880-3900

Study Officials

• Paul I Musey, MD, MS

  Indiana University School of Medicine, Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 7, 2017
• Study Start: January 28, 2018
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2020
• Last Updated: January 24, 2024
• Results First Posted: January 24, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available for 5 years after study completion date.
• Access Criteria: email PI at pmusey@iu.edu

Locations

US (1)