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

Not Applicable

Completed

• Conditions: Anxiety; Mindfulness; Chest Pain
• Interventions: Behavioral: MBSR Referral; Other: Usual Care Referral

• Registration Number: NCT03365375
• Lead Sponsor: Indiana University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-07
• Study Start: 2018-01-28
• Primary Completion: 2019-08-01
• Study Completion: 2020-09-01
• Status Verified: 2023-05
• Results First Submitted: 2023-05-04
• Results First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Results First Posted: 2024-01-24
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBSR Referral	MBSR Referral	Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.
MBSR Referral	Usual Care Referral	Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.
Usual Care Referral	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.

Primary Outcome Measures

Name	Time	Method
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)	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 Outcome Measures

Name	Time	Method
ED Utilization	Measured at 45 days, 3 months, 6 months, and 12 months	Return visits to the Emergency Department
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form	Measured at 45 days, 3 months, 6 months, and 12 months	quality of life
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
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.

Trial Locations

Locations (1)

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States