Cardiac ArrestCALMENCT04589559
The Care After Life-threatening Medical Events Study
A study testing Heart Rate Variability Biofeedback Training in people with Cardiac Arrest and Fear, run by Columbia University at 1 site in United States.
Trial summary
This study tests the feasibility of a home-based heart rate variability biofeedback (HRVB) intervention in survivors of cardiac arrest (CA). Specifically, the primary purpose of this pilot study is to assess feasibility, acceptability, appropriateness, usability, and compliance for an at-home, 3-week HRVB intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Fear
- What is being tested?
- Heart Rate Variability Biofeedback Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2020to 23 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Fluent in English
- A diagnosis of cardiac arrest (CA)
- Time elapsed since their CA is less than 72 months
- Elevated post-traumatic stress disorder (PTSD) symptom total scores on the 17-item Post-Traumatic Stress Disorder Checklist (PCL) of 30 or higher (i.e., greater than the median in a prior sample of cardiac arrest survivors) or elevated PCL-5 scores of 30 or higher or Acute Stress Disorder Scale (ASDS) scores of 34 or higher
- Owns either an iPhone or Android smartphone in order to run the app involved in the intervention
Who cannot join
- Breathing difficulty that does not allow participant to complete the intervention
- Inability to comply with the protocol (either self-selected or indicated during screening that s/he could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia and patients with current alcohol or substance abuse, and patients with severe mental illness (e.g., schizophrenia).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: The Care After Life-threatening Medical Events (CALME) Pilot Study: An Investigation of Heart Rate Variability Biofeedback Training
This study tests the feasibility of a home-based heart rate variability biofeedback (HRVB) intervention in survivors of cardiac arrest (CA). Specifically, the primary purpose of this pilot study is to assess feasibility, acceptability, appropriateness, usability, and compliance for an at-home, 3-week HRVB intervention in 10 participants. The study also tests whether cardiac-related interoceptive fear, trait anxiety, and negative affect decrease among CA survivors completing the HRVB intervention.
Read the detailed description
HRV biofeedback is a technique that combines slow paced breathing with the use of accurate, moment-to-moment physiological monitoring. The goal is to make internal cardiac information available to people in order to help them learn how to increase the beat-to-beat variability in their heart's activity and thereby increase parasympathetic activity of the autonomic nervous system. Apart from active interventions such as exercise training that reliably increase HRV but that may be inappropriate for many cardiac patients, HRV biofeedback is an easy-to-implement technique which allows people to monitor and then ultimately alter their parasympathetic activity.
Research is needed to determine whether HRV biofeedback training has beneficial consequences for mental and cardiovascular health in patients who have experienced serious, life-threatening cardiac events. The investigator believes that cardiac arrest survivors, in particular, may stand to benefit from such an intervention because many of them experience clinically significant psychological distress after their medical event.
Distressed cardiac patients may be especially motivated to learn to influence their own heart activity in order to improve their own HRV, reduce their cardiovascular risk, and lessen their symptoms of psychological distress. Therefore, it may be wise to harness this motivation in the service of helping these patients deliberately learn to alter their own autonomic activity rather than simply breathing at a rate that automatically improves HRV without any learning process. By providing patients with an external (e.g., visual) form of feedback about their otherwise largely inaccessible autonomic physiology (i.e., vagus nerve activity), the investigator will conduct a feasibility study of HRV biofeedback training with the goal of increasing HRV and reducing anxiety symptoms.
The purpose of this pilot study is to examine the feasibility of enrolling 10 participants and assessing the feasibility, acceptability, appropriateness, and usability of the at-home, multi-week HRV biofeedback training as well as participants' compliance with the intervention. Additionally, the purpose of the study is to assess whether participants generally show a decrease in cardiac-related interoceptive fear, a decrease in trait anxiety, a decrease in negative affect, and an increase in HRV during the course of the study. The data collected from participants as part of this feasibility pilot will influence the decision to continue with a larger randomized clinical trial using the methods in this pilot together with a control group. Progress will be monitored with Polar H10 heart rate monitor - a supremely precise heart rate sensor that comes with the Polar Pro chest strap. It will be used with a smartphone app Elite HRV - which is non-experimental.
- Conditions
- Cardiac Arrest, Fear
- Being tested
- Heart Rate Variability Biofeedback Training
- Keywords
- Cardiac arrest, Fear, Psychological distress, Heart Rate Variability Biofeedback
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Variability Biofeedback TrainingBehavioural
Also called HRV Biofeedback
First, participants are taught how to do relaxed, abdominal breathing. Second, they are taught how to breathe at a slow rate of 0.1 Hz (i.e., one completed breath cycle every 10 seconds). Third, they are taught how to monitor their heart rate variability (HRV) in real time using the smartphone app, which receives data wirelessly via Bluetooth from the heart rate monitor. Participants are instructed that their goal is to increase their HRV during the three weeks of at-home practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Heart Rate Variability Biofeedback | Experimental | Participants in this intervention group complete at-home heart rate variability biofeedback (HRVB) training using a chest-worn heart rate monitor and a smartphone app. They complete at least 10 minutes per day of HRVB training on at least 5 days per week for 3 weeks. Receives: Behavioral: Heart Rate Variability Biofeedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Cardiac Arrest (CA) Survivors Whom we Approach Who Ultimately Agree to Participate in the Pilot Study
This is to assess the feasibility of enrollment in the trial. The denominator for this metric is the number of potential participants who were approached and contacted by the study team who were determined to be eligible for the study. The numerator is the number of participants who enrolled in the study (i.e., 10 participants).
Measured: Baseline/Visit 1
Secondary outcomes (10)
Percentage of Enrolled Participants Who Complete the Pilot Study
This is to assess successful program adherence.
Measured: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Percentage of Participants Who Complete a Majority of the At-home HRVB Sessions for the Pilot Study
As a measure of intervention compliance, this is to assess the percentage of participants who complete a majority (>= 8 of 15) of the at-home HRVB sessions.
Measured: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Percentage of Participants Who Report Adequate Feasibility
This is to assess the intervention's feasibility. The percentage of participants who report scores >= 4 for the feasibility total score reflects the percentage of participants who indicated that the intervention is adequately feasible.
Measured: Post-training/Visit 3 (approximately 3 weeks)
Percentage of Participants Who Report Adequate Acceptability
This is to assess the intervention's acceptability. The percentage of participants who report scores >= 4 for the acceptability total score reflects the percentage of participants who indicated that the intervention is adequately acceptable.
Measured: Post-training/Visit 3 (approximately 3 weeks)
Percentage of Participants Who Report Adequate Appropriateness
This is to assess the intervention's appropriateness for reducing anxiety, the proportion of participants who report scores >= 4 would be adequate.
This is to assess the intervention's appropriateness for reducing anxiety. The percentage of participants who report scores >= 4 for the appropriateness-for-reducing-anxiety total score reflects the percentage of participants who indicated that the intervention is adequately appropriate for reducing anxiety.
Measured: Post-training/Visit 3 (approximately 3 weeks)
Percentage of Participants Who Report Adequate Usability
We will assess the percentage of participants who report total scores >= 68 for their rating of the intervention's usability using the System Usability Scale.
Measured: Post-training/Visit 3 (approximately 3 weeks)
Visit-2-to-3 Change in Cardiac-related Interoceptive Fear
This is to assess the Visit-2-to-3 change in cardiac-related interoceptive fear measured as the within-person difference in the sum of the four cardiac-related items from the physical subscale of the Anxiety Sensitivity Index. The total score ranges from a minimum of 0 units on a scale to a maximum of 16 units on a scale. Lower scores indicate lower anxiety.
Measured: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Visit-2-to-3 Change in Trait Anxiety
This is to assess the Visit-2-to-3 change in trait anxiety measured as the within-person difference in the total score of the trait version of the State-Trait Anxiety Inventory. The total score ranges from a minimum of 20 units on a scale to a maximum of 80 units on a scale. Higher scores indicate higher anxiety.
Measured: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Visit-2-to-3 Change in Trait Negative Affect
This is to assess the Visit-2-to-3 change in trait negative affect measured as the within-person difference in the total score of the negative subscale of the Positive and Negative Affect Schedule. The total score ranges from a minimum of 10 units on a scale to a maximum of 50 units on a scale. Lower scores represent lower levels of Negative Affect.
Measured: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Heart Rate Variability (HRV)
This is to assess HRV using participants' exported and deidentified data from the Elite HRV smartphone app. Specifically, HRV is operationalized as the natural log of the root mean square of the successive difference (lnRMSSD), a standard measure of beat-to-beat HRV. This HRV measure is recorded for each at-home training session completed by participants using the app and the heart rate monitor.
Measured: Up to 3 weeks (starting after Visit 2 and extending until Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start23 Nov 2020
- Primary completion23 Jul 2021
- Study completion23 Jul 2021
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 Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention involves heart rate variability biofeedback (HRVB) administered via a smartphone app (Elite HRV) that receives real-time cardiac information from a chest-worn heart rate monitor (Polar H10).
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jeffrey Birk, Columbia University
- Investigators
- Jeffrey L Birk, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589559
- Sponsor's protocol ID
- AAAS9001
- Other IDs
- P30AG064198
- Acronym
- CALME
- Status last verified
- Jul 2022
- First submitted
- 14 Oct 2020
- Last updated
- 19 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Care After Life-threatening Medical Events (CALME) Pilot Study: An Investigation of Heart Rate Variability Biofeedback Training
- ClinicalTrials.gov ID
- NCT04589559
- Acronym / sponsor ID
- CALME / AAAS9001
- Conditions
- Cardiac Arrest, Fear
- Keywords
- Cardiac arrest, Fear, Psychological distress, Heart Rate Variability Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 19 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the feasibility of a home-based heart rate variability biofeedback (HRVB) intervention in survivors of cardiac arrest (CA). Specifically, the primary purpose of this pilot study is to assess feasibility, acceptability, appropriateness, usability, and compliance for an at-home, 3-week HRVB intervention in 10 participants. The study also tests whether cardiac-related interoceptive fear, trait anxiety, and negative affect decrease among CA survivors completing the HRVB intervention.
Detailed description
HRV biofeedback is a technique that combines slow paced breathing with the use of accurate, moment-to-moment physiological monitoring. The goal is to make internal cardiac information available to people in order to help them learn how to increase the beat-to-beat variability in their heart's activity and thereby increase parasympathetic activity of the autonomic nervous system. Apart from active interventions such as exercise training that reliably increase HRV but that may be inappropriate for many cardiac patients, HRV biofeedback is an easy-to-implement technique which allows people to monitor and then ultimately alter their parasympathetic activity.
Research is needed to determine whether HRV biofeedback training has beneficial consequences for mental and cardiovascular health in patients who have experienced serious, life-threatening cardiac events. The investigator believes that cardiac arrest survivors, in particular, may stand to benefit from such an intervention because many of them experience clinically significant psychological distress after their medical event.
Distressed cardiac patients may be especially motivated to learn to influence their own heart activity in order to improve their own HRV, reduce their cardiovascular risk, and lessen their symptoms of psychological distress. Therefore, it may be wise to harness this motivation in the service of helping these patients deliberately learn to alter their own autonomic activity rather than simply breathing at a rate that automatically improves HRV without any learning process. By providing patients with an external (e.g., visual) form of feedback about their otherwise largely inaccessible autonomic physiology (i.e., vagus nerve activity), the investigator will conduct a feasibility study of HRV biofeedback training with the goal of increasing HRV and reducing anxiety symptoms.
The purpose of this pilot study is to examine the feasibility of enrolling 10 participants and assessing the feasibility, acceptability, appropriateness, and usability of the at-home, multi-week HRV biofeedback training as well as participants' compliance with the intervention. Additionally, the purpose of the study is to assess whether participants generally show a decrease in cardiac-related interoceptive fear, a decrease in trait anxiety, a decrease in negative affect, and an increase in HRV during the course of the study. The data collected from participants as part of this feasibility pilot will influence the decision to continue with a larger randomized clinical trial using the methods in this pilot together with a control group. Progress will be monitored with Polar H10 heart rate monitor - a supremely precise heart rate sensor that comes with the Polar Pro chest strap. It will be used with a smartphone app Elite HRV - which is non-experimental.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention involves heart rate variability biofeedback (HRVB) administered via a smartphone app (Elite HRV) that receives real-time cardiac information from a chest-worn heart rate monitor (Polar H10).
| Arm | Type | Receives |
|---|---|---|
| Intervention: Heart Rate Variability Biofeedback | Experimental | Behavioral: Heart Rate Variability Biofeedback TrainingParticipants in this intervention group complete at-home heart rate variability biofeedback (HRVB) training using a chest-worn heart rate monitor and a smartphone app. They complete at least 10 minutes per day of HRVB training on at least 5 days per week for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Fluent in English
- A diagnosis of cardiac arrest (CA)
- Time elapsed since their CA is less than 72 months
- Elevated post-traumatic stress disorder (PTSD) symptom total scores on the 17-item Post-Traumatic Stress Disorder Checklist (PCL) of 30 or higher (i.e., greater than the median in a prior sample of cardiac arrest survivors) or elevated PCL-5 scores of 30 or higher or Acute Stress Disorder Scale (ASDS) scores of 34 or higher
Key exclusion criteria (2 listed)
- Breathing difficulty that does not allow participant to complete the intervention
- Inability to comply with the protocol (either self-selected or indicated during screening that s/he could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia and patients with current alcohol or substance abuse, and patients with severe mental illness (e.g., schizophrenia).
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 |
|---|---|---|
| Heart Rate Variability Biofeedback TrainingAlso: HRV BiofeedbackFirst, participants are taught how to do relaxed, abdominal breathing. Second, they are taught how to breathe at a slow rate of 0.1 Hz (i.e., one completed breath cycle every 10 seconds). Third, they are taught how to monitor their heart rate variability (HRV) in real time using the smartphone app, which receives data wirelessly via Bluetooth from the heart rate monitor. Participants are instructed that their goal is to increase their HRV during the three weeks of at-home practice. | Behavioural | Intervention: Heart Rate Variability Biofeedback |
Primary outcome
Percentage of Eligible Cardiac Arrest (CA) Survivors Whom we Approach Who Ultimately Agree to Participate in the Pilot Study
Time frame: Baseline/Visit 1
This is to assess the feasibility of enrollment in the trial. The denominator for this metric is the number of potential participants who were approached and contacted by the study team who were determined to be eligible for the study. The numerator is the number of participants who enrolled in the study (i.e., 10 participants).
10 secondary outcomes
Percentage of Enrolled Participants Who Complete the Pilot Study
Time frame: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Percentage of Participants Who Complete a Majority of the At-home HRVB Sessions for the Pilot Study
Time frame: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Percentage of Participants Who Report Adequate Feasibility
Time frame: Post-training/Visit 3 (approximately 3 weeks)
Percentage of Participants Who Report Adequate Acceptability
Time frame: Post-training/Visit 3 (approximately 3 weeks)
Percentage of Participants Who Report Adequate Appropriateness
Time frame: Post-training/Visit 3 (approximately 3 weeks)
Percentage of Participants Who Report Adequate Usability
Time frame: Post-training/Visit 3 (approximately 3 weeks)
Visit-2-to-3 Change in Cardiac-related Interoceptive Fear
Time frame: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Visit-2-to-3 Change in Trait Anxiety
Time frame: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Visit-2-to-3 Change in Trait Negative Affect
Time frame: Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Heart Rate Variability (HRV)
Time frame: Up to 3 weeks (starting after Visit 2 and extending until Visit 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jeffrey L Birk, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Rate Variability Biofeedback Training in people with Cardiac Arrest and Fear, run by Columbia 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 6 inclusion and 2 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 19 Aug 2022. 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 19 Aug 2022). 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?
Percentage of Eligible Cardiac Arrest (CA) Survivors Whom we Approach Who Ultimately Agree to Participate in the Pilot Study (time frame: Baseline/Visit 1). 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 19 Aug 2022.