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

Anxiety Clinical Trial

— MBSR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365375
• Other study ID #: VFR-447 Musey
• Status: Completed
• Phase: N/A
• Start date: January 28, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Chest Pain
• Mindfulness

Intervention

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

Other:
• Usual Care Referral
Referral to PCP or Psychiatry

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Healthcare Utilization	Visits to care professionals other then the ED	Measured at 45 days, 3 months, 6 months, and 12 months
Other	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
Other	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
Other	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
Primary	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	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
Secondary	ED Utilization	Return visits to the Emergency Department	Measured at 45 days, 3 months, 6 months, and 12 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form	quality of life	Measured at 45 days, 3 months, 6 months, and 12 months
Secondary	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
Secondary	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