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Behavioral Intervention
MBSR Referral for Mindfulness (MBSR Trial)
N/A
Waitlist Available
Led By Paul I Musey, MD, MS
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 3 months
Awards & highlights
MBSR 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).
Eligible Conditions
- Mindfulness
- Anxiety
- Chest Pain
MBSR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)
Secondary outcome measures
Cognitive and Affective Mindfulness Scale - Revised
ED Utilization
Generalized Anxiety Disorder -7
+2 moreOther outcome measures
Healthcare Utilization
PTSD Screener
Panic Screener
+3 moreMBSR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MBSR ReferralExperimental Treatment2 Interventions
Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.
Group II: Usual Care ReferralActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MBSR Referral
2018
N/A
~30
Find a Location
Who is running the clinical trial?
Indiana University HealthOTHER
30 Previous Clinical Trials
16,005 Total Patients Enrolled
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,133 Total Patients Enrolled
1 Trials studying Mindfulness
108 Patients Enrolled for Mindfulness
Paul I Musey, MD, MSPrincipal InvestigatorIndiana University School of Medicine, Department of Emergency Medicine
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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