Anxiety, Chest Pain, Mindfulness
Conditions
Keywords
Chest Pain, Anxiety, Mindfulness, Emergency Service, Hospital
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.
Interventions
BEHAVIORALMBSR Referral
Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
OTHERUsual Care Referral
Referral to PCP or Psychiatry
Sponsors
Indiana University Health
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) | Measured at 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder -7 | Measured at 45 days, 6 months, and 12 months | Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe \> 15 |
| ED Utilization | Measured at 45 days, 3 months, 6 months, and 12 months | Return visits to the Emergency Department |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form | Measured at 45 days, 3 months, 6 months, and 12 months | quality of life |
| Cognitive and Affective Mindfulness Scale - Revised | Measured at 45 days, 3 months, 6 months, and 12 months | 12-item measure (each scored 1-4) with total of 48. A higher score is consistent with greater mindfulness qualities. |
| Toronto Mindfulness Scale | Measured at 45 days, 3 months, 6 months, and 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 8 (Depression) | Measured at 45 days, 3 months, 6 months, and 12 months | 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) |
| Patient Health Questionnaire - 15 (Physical Symptoms) | 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 |
| Healthcare Utilization | Measured at 45 days, 3 months, 6 months, and 12 months | Visits to care professionals other then the ED |
| PTSD Screener | Measured at 45 days, 3 months, 6 months, and 12 months | 4 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a PTSD. |
| Panic Screener | Measured at 45 days, 3 months, 6 months, and 12 months | 5 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a panic disorder. |
| Social Anxiety Screener | Measured at 45 days, 3 months, 6 months, and 12 months | 3 item measure (each scored 1-4) with total possible score of 12. Higher score associated with higher social anxiety |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| MBSR Referral MBSR Referral: Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Usual Care Referral | MBSR Referral | Total |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 9.3 | 38.9 years STANDARD_DEVIATION 11.9 | 41.2 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 12 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| GAD-7 at enrollment | 15.9 units on a scale STANDARD_DEVIATION 4.4 | 14.9 units on a scale STANDARD_DEVIATION 3.1 | 15.3 units on a scale STANDARD_DEVIATION 3.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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
Time frame: Measured at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Referral | Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) | 5.3 score on a scale | Standard Deviation 5.4 |
| MBSR Referral | Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) | 3.2 score on a scale | Standard Deviation 8.1 |
p-value: 0.82t-test, 2 sided
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.
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Secondary
ED Utilization
Return visits to the Emergency Department
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Secondary
Generalized Anxiety Disorder -7
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
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form
quality of life
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
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.
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Other Pre-specified
Healthcare Utilization
Visits to care professionals other then the ED
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Other Pre-specified
Panic Screener
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
Other Pre-specified
Patient Health Questionnaire - 15 (Physical Symptoms)
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
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)
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Other Pre-specified
PTSD Screener
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
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
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months