Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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. |
Behavioral: MBSR Referral
Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
Other Names:
Other: Usual Care Referral
Referral to PCP or Psychiatry
|
Outcome Measures
Primary Outcome Measures
- Generalized Anxiety Disorder -7 [Measured at 3 months]
Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15
Secondary Outcome Measures
- Generalized Anxiety Disorder -7 [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
- ED Utilization [Measured at 45 days, 3 months, 6 months, and 12 months]
Return visits to the Emergency Department
- PROMIS Global Short Form [Measured at 45 days, 3 months, 6 months, and 12 months]
quality of life
- Cognitive and Affective Mindfulness Scale - Revised [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.
- Toronto Mindfulness Scale [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 Outcome Measures
- Patient Health Questionnaire - 8 (Depression) [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)
- Patient Health Questionnaire - 15 (Physical symptoms) [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
- Healthcare Utilization [Measured at 45 days, 3 months, 6 months, and 12 months]
Visits to care professionals other then the ED
- PTSD Screener [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.
- Panic Screener [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.
- Social Anxiety Screener [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
Eligibility Criteria
Criteria
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)
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Previous enrollment in the study
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Traumatic injury to the chest
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IU Health Methodist Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
- Indiana University Health
Investigators
- Principal Investigator: Paul I Musey, MD, MS, Indiana University School of Medicine, Department of Emergency Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VFR-447 Musey