N/A N=28 Single-blind Treatment

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

Chest Pain · Anxiety · Mindfulness

Bottom Line

View on ClinicalTrials.gov: NCT03365375 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) — 5.3; 3.2 score on a scale — p=0.82

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MBSR Referral (Behavioral); Usual Care Referral (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)	5.3; 3.2	0.82
SECONDARY Generalized Anxiety Disorder -7	—	—
SECONDARY ED Utilization	—	—
SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form	—	—
SECONDARY Cognitive and Affective Mindfulness Scale - Revised	—	—
SECONDARY Toronto Mindfulness Scale	—	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03365375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.