Clinical trial NCT03365375: Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
Official title: Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Anxiety
Mindfulness
Keywords: Chest Pain
Anxiety
Mindfulness
Emergency Service, Hospital
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
First posted: 2017-12-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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)
* 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

Primary outcomes:
measure: Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)
timeFrame: Measured at 3 months
Secondary outcomes:
measure: Generalized Anxiety Disorder -7
timeFrame: Measured at 45 days, 6 months, and 12 months
measure: ED Utilization
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
measure: Cognitive and Affective Mindfulness Scale - Revised
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
measure: Toronto Mindfulness Scale
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
Other outcomes:
measure: Patient Health Questionnaire - 8 (Depression)
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
measure: Patient Health Questionnaire - 15 (Physical Symptoms)
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
measure: Healthcare Utilization
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
measure: PTSD Screener
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
measure: Panic Screener
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
measure: Social Anxiety Screener
timeFrame: Measured at 45 days, 3 months, 6 months, and 12 months
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine, Department of Emergency Medicine
name: Paul I Musey, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: