Chest PainMBSRNCT03365375
Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
A study testing MBSR Referral in people with Chest Pain and Anxiety, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chest Pain, Anxiety, Mindfulness
- What is being tested?
- MBSR Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Hemodynamic instability
- Non-English speaking
- Potential issues affecting follow up: Prisoners, homeless patients, out-of-town residences
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot Trial
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).
Read the 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.
- Conditions
- Chest Pain, Anxiety, Mindfulness
- Being tested
- MBSR Referral, Usual Care Referral
- Keywords
- Chest Pain, Anxiety, Mindfulness, Emergency Service, Hospital
- Medical subject headings
- Chest Pain, Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR ReferralBehavioural
Also called MBSR
Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
Usual Care ReferralOther
Referral to PCP or Psychiatry
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Usual Care Referral |
| MBSR Referral | Experimental | Referral to a local mindfulness-based stress reduction course in addition to referral to their PCP. Receives: Behavioral: MBSR Referral; Other: Usual Care Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 3 months
Secondary outcomes (5)
Generalized Anxiety Disorder -7
Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe > 15
Measured: Measured at 45 days, 6 months, and 12 months
ED Utilization
Return visits to the Emergency Department
Measured: 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: 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: 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: Measured at 45 days, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start28 Jan 2018
- Primary completion1 Aug 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Paul Musey, Indiana University
- Investigators
- Paul I Musey, MD, MS, Principal investigator, Indiana University School of Medicine, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365375
- Sponsor's protocol ID
- VFR-447 Musey
- Acronym
- MBSR
- Status last verified
- May 2023
- First submitted
- 27 Nov 2017
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from the clinical study report and the study protocol will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety: A Pilot Trial
- ClinicalTrials.gov ID
- NCT03365375
- Acronym / sponsor ID
- MBSR / VFR-447 Musey
- Conditions
- Chest Pain, Anxiety, Mindfulness
- Keywords
- Chest Pain, Anxiety, Mindfulness, Emergency Service, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Posted 24 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Referral | Active comparator | Other: Usual Care ReferralSubjects 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 | Behavioral: MBSR Referral, Other: Usual Care ReferralReferral to a local mindfulness-based stress reduction course in addition to referral to their PCP. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSR ReferralAlso: MBSRReferral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions. | Behavioural | MBSR Referral |
| Usual Care ReferralReferral to PCP or Psychiatry | Other | MBSR Referral, Usual Care Referral |
Primary outcome
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)
Time frame: 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
5 secondary outcomes
Generalized Anxiety Disorder -7
Time frame: Measured at 45 days, 6 months, and 12 months
ED Utilization
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Cognitive and Affective Mindfulness Scale - Revised
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Toronto Mindfulness Scale
Time frame: Measured at 45 days, 3 months, 6 months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data from the clinical study report and the study protocol will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul I Musey, MD, MS principal investigator
Indiana University School of Medicine, Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR Referral in people with Chest Pain and Anxiety, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7) (time frame: Measured at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.