Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
Primary Purpose
Chest Pain, Anxiety, Mindfulness
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBSR Referral
Usual Care Referral
Sponsored by
About this trial
This is an interventional treatment trial for Chest Pain focused on measuring Chest Pain, Anxiety, Mindfulness, Emergency Service, Hospital
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
Sites / Locations
- IU Health Methodist HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care Referral
MBSR Referral
Arm Description
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.
Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.
Outcomes
Primary Outcome Measures
Generalized Anxiety Disorder -7
Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15
Secondary Outcome Measures
Generalized Anxiety Disorder -7
Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15
ED Utilization
Return visits to the Emergency Department
PROMIS Global Short Form
quality of life
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.
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.
Full Information
NCT ID
NCT03365375
First Posted
November 27, 2017
Last Updated
July 23, 2018
Sponsor
Indiana University
Collaborators
Indiana University Health
1. Study Identification
Unique Protocol Identification Number
NCT03365375
Brief Title
Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
Official Title
Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Indiana University Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Anxiety, Mindfulness
Keywords
Chest Pain, Anxiety, Mindfulness, Emergency Service, Hospital
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care Referral
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MBSR Referral
Arm Type
Experimental
Arm Description
Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.
Intervention Type
Behavioral
Intervention Name(s)
MBSR Referral
Other Intervention Name(s)
MBSR
Intervention Description
Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
Intervention Type
Other
Intervention Name(s)
Usual Care Referral
Intervention Description
Referral to PCP or Psychiatry
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder -7
Description
Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15
Time Frame
Measured at 3 months
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder -7
Description
Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15
Time Frame
Measured at 45 days, 6 months, and 12 months
Title
ED Utilization
Description
Return visits to the Emergency Department
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Title
PROMIS Global Short Form
Description
quality of life
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Title
Cognitive and Affective Mindfulness Scale - Revised
Description
12-item measure (each scored 1-4) with total of 48. A higher score is consistent with greater mindfulness qualities.
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Title
Toronto Mindfulness Scale
Description
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.
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Other Pre-specified Outcome Measures:
Title
Patient Health Questionnaire - 8 (Depression)
Description
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)
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Title
Patient Health Questionnaire - 15 (Physical symptoms)
Description
Somatic symptom severity: Minimal 0-4, Low 5-9, Medium 10-14, High 15-30
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Title
Healthcare Utilization
Description
Visits to care professionals other then the ED
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Title
PTSD Screener
Description
4 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a PTSD.
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Title
Panic Screener
Description
5 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a panic disorder.
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
Title
Social Anxiety Screener
Description
3 item measure (each scored 1-4) with total possible score of 12. Higher score associated with higher social anxiety
Time Frame
Measured at 45 days, 3 months, 6 months, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul I Musey, MD, MS
Phone
317-880-3900
Email
pmusey@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul I Musey, MD, MS
Organizational Affiliation
Indiana University School of Medicine, Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul I Musey, MD
Phone
317-880-3894
Email
pmusey@iu.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
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