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| Name | Class |
|---|---|
| Indiana University Health | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Referral | Active Comparator | 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. |
|
| MBSR Referral | Experimental | Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBSR Referral | Behavioral | Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) | 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 | Measured at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder -7 | Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15 | Measured at 45 days, 6 months, and 12 months |
| ED Utilization | Return visits to the Emergency Department |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire - 8 (Depression) | 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) | Measured at 45 days, 3 months, 6 months, and 12 months |
| Patient Health Questionnaire - 15 (Physical Symptoms) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul I Musey, MD, MS | Indiana University School of Medicine, Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
Deidentified data from the clinical study report and the study protocol will be shared upon request.
Data will be available for 5 years after study completion date.
email PI at pmusey@iu.edu
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We screened patients who presented to the Emergency Department (ED) with chest pain. We assessed their risk for major adverse cardiac events (MACE) using the HEART score and for anxiety with the GAD-7. Enrolled subjects were assigned to either arm depending upon enrollment period. In the 8 weeks prior to the MBSR course commencement all subjects enrolled were assigned to Arm 2: MBSR. This period was immediately followed by 8 weeks of enrollment in Arm 1: Standard Referral.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | MBSR Referral | MBSR Referral: Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | MBSR Referral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) | 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 | Posted | Mean | Standard Deviation | score on a scale | Measured at 3 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Musey | Indiana University | 317-880-3900 | pmusey@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2019 | May 4, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2019 | May 4, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D001008 | Anxiety Disorders |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Usual Care Referral | Other | Referral to PCP or Psychiatry |
|
| Measured at 45 days, 3 months, 6 months, and 12 months |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form | quality of life | Measured at 45 days, 3 months, 6 months, and 12 months |
| 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. | Measured at 45 days, 3 months, 6 months, and 12 months |
| 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. | Measured at 45 days, 3 months, 6 months, and 12 months |
Somatic symptom severity: Minimal 0-4, Low 5-9, Medium 10-14, High 15-30 |
| Measured at 45 days, 3 months, 6 months, and 12 months |
| Healthcare Utilization | Visits to care professionals other then the ED | Measured at 45 days, 3 months, 6 months, and 12 months |
| PTSD Screener | 4 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a PTSD. | Measured at 45 days, 3 months, 6 months, and 12 months |
| Panic Screener | 5 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a panic disorder. | Measured at 45 days, 3 months, 6 months, and 12 months |
| Social Anxiety Screener | 3 item measure (each scored 1-4) with total possible score of 12. Higher score associated with higher social anxiety | Measured at 45 days, 3 months, 6 months, and 12 months |
MBSR Referral: Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| GAD-7 at enrollment | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Generalized Anxiety Disorder -7 | Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15 | Not Posted | Measured at 45 days, 6 months, and 12 months | Participants |
| Secondary | ED Utilization | Return visits to the Emergency Department | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form | quality of life | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Secondary | 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. | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Secondary | 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. | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Other Pre-specified | Patient Health Questionnaire - 8 (Depression) | 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) | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Other Pre-specified | Patient Health Questionnaire - 15 (Physical Symptoms) | Somatic symptom severity: Minimal 0-4, Low 5-9, Medium 10-14, High 15-30 | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Other Pre-specified | Healthcare Utilization | Visits to care professionals other then the ED | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Other Pre-specified | PTSD Screener | 4 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a PTSD. | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Other Pre-specified | Panic Screener | 5 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a panic disorder. | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| Other Pre-specified | Social Anxiety Screener | 3 item measure (each scored 1-4) with total possible score of 12. Higher score associated with higher social anxiety | Not Posted | Measured at 45 days, 3 months, 6 months, and 12 months | Participants |
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | MBSR Referral | MBSR Referral: Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |