N/A
Completed N=28
Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
Postoperative Pain · Anxiety · Mindfulness
Source: ClinicalTrials.gov NCT03365375 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) — 5.3; 3.2 score on a scale — p=0.82
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).
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 |
— | — |
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
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. Informational only — not medical advice.