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Completed

NCT Number: NCT03365375

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

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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Key information

Conditions

Chest Pain Anxiety Anxiety Disorders Disease Attributes Emergencies Mental Disorders Mindfulness Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBSR Referral

Behavioral

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

Other names: MBSR

Usual Care Referral

Other

Referral to PCP or Psychiatry

Primary outcomes

  1. Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)

    Time frame: Measured at 3 months

    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

Secondary outcomes

  1. Generalized Anxiety Disorder -7

    Time frame: Measured at 45 days, 6 months, and 12 months

    Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15

  2. ED Utilization

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    Return visits to the Emergency Department

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

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    quality of life

  4. Cognitive and Affective Mindfulness Scale - Revised

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    12-item measure (each scored 1-4) with total of 48. A higher score is consistent with greater mindfulness qualities.

  5. Toronto Mindfulness Scale

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    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.

Other outcomes

  1. Patient Health Questionnaire - 8 (Depression)

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    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)

  2. Patient Health Questionnaire - 15 (Physical Symptoms)

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    Somatic symptom severity: Minimal 0-4, Low 5-9, Medium 10-14, High 15-30

  3. Healthcare Utilization

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    Visits to care professionals other then the ED

  4. PTSD Screener

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    4 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a PTSD.

  5. Panic Screener

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    5 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a panic disorder.

  6. Social Anxiety Screener

    Time frame: Measured at 45 days, 3 months, 6 months, and 12 months

    3 item measure (each scored 1-4) with total possible score of 12. Higher score associated with higher social anxiety

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health

Registry information

Official study title

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

Acronym: MBSR

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 7, 2017
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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