An interventional study of MBSR Referral and Usual Care Referral in Chest Pain, Anxiety and Mindfulness, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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.
388 studies on the registry are indexed under Chest Pain; 64 are open to participants now.
This study's enrollment of 28 is below the median of 129 across 204 interventional studies indexed under Chest Pain.
Browse Chest Pain studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Usual Care Referral
Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP.
Behavioral: MBSR Referral · Other: Usual Care Referral
Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
Also known as: MBSR
Referral to PCP or Psychiatry
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
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
ED Utilization
Return visits to the Emergency Department
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
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
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
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
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
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
Healthcare Utilization
Visits to care professionals other then the ED
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
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.
| Milestone | Usual Care Referral | MBSR Referral |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 9 |
| Not completed | 0 | 5 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 4 |
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
| score on a scale | Usual Care Referral | MBSR Referral |
|---|---|---|
| Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) | 5.3 ± 5.4 | 3.2 ± 8.1 |
Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe \> 15
Results for this outcome have not been posted.
Return visits to the Emergency Department
Results for this outcome have not been posted.
quality of life
Results for this outcome have not been posted.
12-item measure (each scored 1-4) with total of 48. A higher score is consistent with greater mindfulness qualities.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
Somatic symptom severity: Minimal 0-4, Low 5-9, Medium 10-14, High 15-30
Results for this outcome have not been posted.
Visits to care professionals other then the ED
Results for this outcome have not been posted.
4 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a PTSD.
Results for this outcome have not been posted.
5 item measure (each scored 0 or 1). Higher score associated with higher likelihood of a panic disorder.
Results for this outcome have not been posted.
3 item measure (each scored 1-4) with total possible score of 12. Higher score associated with higher social anxiety
Results for this outcome have not been posted.
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care Referral | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| MBSR Referral | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Usual Care Referral | MBSR Referral | Total |
|---|---|---|---|
| Mean | 43.3 ± 9.3 | 38.9 ± 11.9 | 41.2 ± 11.1 |
| Sex: Female, Male(Participants) | Usual Care Referral | MBSR Referral | Total |
|---|---|---|---|
| Female | 11 | 9 | 20 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care Referral | MBSR Referral | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 13 | 12 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Usual Care Referral | MBSR Referral | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 7 | 14 |
| White | 6 | 5 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
| GAD-7 at enrollment(units on a scale) | Usual Care Referral | MBSR Referral | Total |
|---|---|---|---|
| Mean | 15.9 ± 4.4 | 14.9 ± 3.1 | 15.3 ± 3.6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified data from the clinical study report and the study protocol will be shared upon request.
Supporting information: Study protocol, Clinical study report
Time frame: Data will be available for 5 years after study completion date.
Access criteria: email PI at pmusey@iu.edu
Ran from Jan 2018 to primary completion in Aug 2019, 18 months.
Results were first posted in Jan 2024, 4 years 5 months after primary completion.
Of 84 non-industry interventional studies with no phase under Chest Pain, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 18 months is below that.
Counting every sponsor, half of 86 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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