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Heart Rate VariabilityHRV-BFNCT05897580

Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness

A study testing Heart Rate Variability - Biofeedback (HRV-BF) and Health Promotion (HP) in people with Heart Rate Variability, run by University of California, Irvine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this randomized controlled trial was to compare the effectiveness of an HRV-BF intervention versus a health promotion active control intervention focused on improving mental health symptoms among people experiencing homelessness (PEH), who were residing in Skid Row, Los Angeles. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Rate Variability
What is being tested?
Heart Rate Variability - Biofeedback (HRV-BF) and Health Promotion (HP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
22 Feb 2022to 21 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age 18 and older
  • self-reported as residing in a homeless living condition during the previous night
  • self-reported having used illicit substances or alcohol during the past year

Who cannot join

  • Persons who:
  • exclusively spoke languages other than English or Spanish
  • were unable to understand informed consent
  • had cardiac deficiency, arrhythmias or pacemakers or who took medications affecting autonomic function.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Amity Foundation, Los Angeles

    Los Angeles, California, 90007

  • Downtown Women Center, Los Angeles

    Los Angeles, California, 90013

  • Los Angeles Christian Health Centers (LACHC)

    Los Angeles, California, 90013

Other trials in United States

About this study

The purpose of this randomized controlled trial was to compare the effectiveness of an HRV-BF intervention versus a health promotion active control intervention focused on improving mental health symptoms among people experiencing homelessness (PEH), who were residing in Skid Row, Los Angeles. In total, 40 PEH were randomized to either the HRV-BF or an active health promotion control group, and received 8 weekly, 30-minute sessions over a two month period, delivered by a nurse-led community health worker team. Dependent variables of HRV, mental health, anxiety, depression and PTSD were measured at baseline, the 8-week session, and/or 2-month follow up.

Read the detailed description

In this pilot randomized controlled trial, conducted over one year, beginning in April 2021, 40 PEH were recruited from a larger sample of 100 PEH that were participating in a survey on COVID-19. Our outcomes were HRV and symptoms of anxiety, depression and PTSD.

Prior to the intervention, a Community Advisory Board (CAB) met to assess feasibility and acceptability of the HRV-BF program, which was presented in a theater-style approach. The CAB, composed of 6 PEH, and 3 healthcare providers, spoke quite favorably about the program, and provided exceptional feedback in terms of acceptability and feasibility in delivery logistics and cultural sensitivity. PEH shared the high levels of stress and anxiety they were experiencing; how helpful they perceived the program to be, the best timing for delivery, length of time for the intervention (under 60 minutes), and how to minimize attrition. Our study was approved by the Human Subjects Protection Committee at the University of California, Irvine and the University of California, Los Angeles.

Being tested
Heart Rate Variability - Biofeedback (HRV-BF), Health Promotion (HP)
Keywords
heart rate variability, mental health, anxiety, depression, PTSD
Medical subject headings
Psychological Well-Being, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart Rate Variability - Biofeedback (HRV-BF)Behavioural

    The HRV-BF was delivered over 30 minutes once weekly for 8 weeks by our nurse-led Community Health Worker (RN/CHW) team trained to deliver scripted material created by a trained biofeedback practitioner on our study team. The weekly sessions included the use of a tablet device to share a 10-minute video which teaches the basic techniques and breathing practices of HRV-BF and guiding the participant through a 20-minute practice, using the techniques while watching their heart rate data in real time using an HRV-BF device, the EmWave Pro (HeartMath).

    Participants were also asked to complete daily practices on their own, without the HRV-BF device, for 10 minutes, twice a day, to reinforce topics and skills taught in videos. Practices logged by the participant were collected weekly by the CHW and referral to resources were provided.

  • Health Promotion (HP)Behavioural

    The HP active control group was delivered over 30 minutes, once weekly for 8 weeks by our nurse-led Community Health Worker team, trained to deliver scripted materialized content created. In the HP program, PEH were educated on common physical chronic diseases PEH experience, including hypertension, diabetes, heart disease and arthritis, along with referrals provided based on needs expressed by PEH.

Study groups in NCT05897580
Study groupRoleWhat they receive
Heart Rate Variability-Biofeedback (HRV-BF)ExperimentalHeart Rate Variability-Biofeedback (HRV-BF) is a process by which physiological markers such as heart rate, respiration, and HRV are measured and "fed" back to the person on a computer screen. Guided paced slowed breathing, a skill taught in HRV-BF, maximizes the natural acceleration of heart rate with inspiration and deceleration with expiration and produces a rhythmic stimulation of the vagus nerve, providing the basis for the overall increase in parasympathetic/vagal tone over time if practiced regularly.
Receives: Behavioral: Heart Rate Variability - Biofeedback (HRV-BF)
Health Promotion (HP)Active comparatorThe Health Promotion (HP) active control group was originally developed utilizing community-based participatory research elements, including the establishment of a Community Advisory Board (CAB), with community stakeholders, social service providers and academicians and a manualized program was developed for the HP program. The 8-week program focused on the most common physical chronic diseases PEH experience, and included discussions of hypertension, diabetes, heart disease and arthritis; total over eight weeks, along with full discussion and referrals provided based on needs expressed by PEH.
Receives: Behavioral: Health Promotion (HP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Heart Rate Variability

    Commercially available, medical grade photodetector (photoplethysmography or PPG) sensor and accompanying HRV-BF software application (EmWave Pro Plus, HeartMath) will be used to collect interbeat interval data to produce standard measures of HRV including time-domain measures of SDNN (standard deviation of N-to-N intervals) and RMSSD (Root mean square of successive differences between normal heart beats). Both SDNN and RMSSD are measured in milliseconds (ms). RMSSD is most reflective of vagal tone and is our primary outcome measure.

    Measured: Change Assessed during the resting 5-minute period at week 1 and week 8 sessions

Secondary outcomes (7)

  1. Mental Health Status

    Assessed by the Mental Health Inventory-5 (MHI-5) which has well-demonstrated reliability for detecting psychological disorders with reliabilities of .77 and .71 for women/men, respectively. Minimum = 5; Maximum = 30; Higher score means a better outcome.

    Measured: Baseline and 8 weeks

  2. Anxiety Symptoms

    Anxiety Symptoms were measured by the Generalized Anxiety Disorder -7, a self-report 7- item measure. Example items include "worrying too much about different things," and "trouble relaxing" (Endpoints 0=not at all; 3=nearly every day). Scores are summed. Severity of anxiety was determined with cut-off scores 5 (mild anxiety), 10 (moderate anxiety), and 15 (severe anxiety). Reliability α=0.87. Minimum = 0; Maximum = 21; Higher score means a worse outcome.

    Measured: Baseline and 8 weeks

  3. Depression Symptoms

    Depressive Symptoms were assessed by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a brief, 9 question depression module from the full 26-item PHQ. Each of the 9 items address the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria, rating them from "0" (not at all) to "3" (nearly every day). PHQ-9 not only makes criteria-based diagnoses of depressive disorders, but as well can determine severity, with scoring cut-offs for minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27) depression. Reliability of the PHQ-9 is α=0.89. Minimum = 0; Maximum = 27; Higher score means a worse outcome.

    Measured: Baseline and 8 weeks

  4. Post Traumatic Stress Disorder (PTSD)

    PTSD was measured by means of the Post Traumatic Stress Disorder Checklist-5 (PCL-C), a 17-item screener for PTSD with cut points for symptomatic vs non-symptomatic; scores correlate highly with the Clinician Administered PTSD scale, r = .93.70 The PCL-C has high levels of validity,71 test-retest reliability (r = .96), and high internal consistency (α = .97). The self-report rating scale is 0-4 for each symptom: "Not at All" to "Extremely" (0-80). 5-point change is a minimum threshold for determining a treatment response, while a 10-point change is a minimum threshold for determining a clinically meaningful treatment response. Minimum = 17; Maximum = 85; Higher score means a worse outcome.

    Measured: Baseline and 8 weeks

  5. Drug and Alcohol Use

    Drug and Alcohol Use was assessed by the Texas Christian University (TCU) Drug History Form. It records the frequency of use of 16 drugs used over 12 months, such as heroin and other opiates, street methadone, cocaine, crack, methamphetamine, etc. Yes/No to each drug was assessed for use vs dependency. The total score ranges from 0 - 9; higher scores (> 3) correspond to the DSM 4 drug dependence diagnosis. Minimum = 0; Maximum = 11; Higher score means a worse outcome.

    Measured: Baseline and 8 weeks

  6. Physical Disease

    Physical Diseases was assessed by the self-reported comorbidity index (SCQ) for medical problem, treatment, and limitations. PEH were asked to respond if they have chronic health conditions (e.g., heart disease, high blood pressure, diabetes, osteoarthritis). Responses include "yes or no". In a previous PEH sample (N=150), Cronbach's α = .91.

    Physical Diseases was assessed by the self-reported comorbidity index (SCQ) for medical problem, treatment, and limitations. PEH were asked to respond if they have chronic health conditions (e.g., heart disease, high blood pressure, diabetes, osteoarthritis. Responses include "yes or no". In a previous PEH sample (N=150), Cronbach's α = .91. Minimum = 0; Maximum = 36; Higher score means a worse outcome.

    Measured: Baseline and 8 weeks

  7. Assessing Evidence of Drug Use in Urine

    Urinalysis: In addition, we conducted a urine assay which measures cannabis, methamphetamine, cocaine, and amphetamines. A five-panel Food and Drug Administration-approved urine test cup was used at baseline and 8 week follow-up. The test cup screened for metabolites of Amphetamines (1000 ng/mL), Cocaine (300 ng/mL), Methamphetamines (500 ng/mL), Opiates (2000 ng/mL), and Cannabis (THC) (50 ng/mL).

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start22 Feb 2022
  3. Primary completion21 Jun 2022
  4. Study completion21 Oct 2022

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Heart rate variability-biofeedback (HRV-BF) has been shown to decrease symptoms of stress, anxiety, depression, and PTSD, however HRV-BF has not been tested with the most vulnerable of populations, homeless adults
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897580
Sponsor's protocol ID
20216820
Acronym
HRV-BF
Status last verified
Jun 2023
First submitted
12 May 2023
Last updated
9 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Berwick DM, Murphy JM, Goldman PA, Ware JE Jr, Barsky AJ, Weinstein MC. Performance of a five-item mental health screening test. Med Care. 1991 Feb;29(2):169-76. doi: 10.1097/00005650-199102000-00008.

    PubMed 1994148

  • Blackburn L, Owens GP. The effect of self efficacy and meaning in life on posttraumatic stress disorder and depression severity among veterans. J Clin Psychol. 2015 Mar;71(3):219-28. doi: 10.1002/jclp.22133. Epub 2014 Sep 30.

    PubMed 25270887

  • Forbes D, Creamer M, Biddle D. The validity of the PTSD checklist as a measure of symptomatic change in combat-related PTSD. Behav Res Ther. 2001 Aug;39(8):977-86. doi: 10.1016/s0005-7967(00)00084-x.

    PubMed 11480838

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.

    PubMed 28265249

  • Leake B, Nyamathi A, Gelberg L. Reliability, validity, and composition of a subset of the Centers for Disease Control and Prevention acquired immunodeficiency syndrome knowledge questionnaire in a sample of homeless and impoverished adults. Med Care. 1997 Aug;35(8):747-55. doi: 10.1097/00005650-199708000-00001.

    PubMed 9268248

  • Lehrer P, Kaur K, Sharma A, Shah K, Huseby R, Bhavsar J, Sgobba P, Zhang Y. Heart Rate Variability Biofeedback Improves Emotional and Physical Health and Performance: A Systematic Review and Meta Analysis. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):109-129. doi: 10.1007/s10484-020-09466-z.

    PubMed 32385728

  • McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD checklist: a critical review. Clin Psychol Rev. 2010 Dec;30(8):976-87. doi: 10.1016/j.cpr.2010.06.012. Epub 2010 Jul 6.

    PubMed 20705376

  • Nyamathi A. Comprehensive health seeking and coping paradigm. J Adv Nurs. 1989 Apr;14(4):281-90. doi: 10.1111/j.1365-2648.1989.tb03415.x.

    PubMed 2661620

  • Porges SW. The polyvagal perspective. Biol Psychol. 2007 Feb;74(2):116-43. doi: 10.1016/j.biopsycho.2006.06.009. Epub 2006 Oct 16.

    PubMed 17049418

  • Salem BE, Ma-Pham J. Understanding Health Needs and Perspectives of Middle-Aged and Older Women Experiencing Homelessness. Public Health Nurs. 2015 Nov-Dec;32(6):634-44. doi: 10.1111/phn.12195. Epub 2015 Mar 31.

    PubMed 25832775

  • Samuelson KW, Bartel A, Valadez R, Jordan JT. PTSD symptoms and perception of cognitive problems: The roles of posttraumatic cognitions and trauma coping self-efficacy. Psychol Trauma. 2017 Sep;9(5):537-544. doi: 10.1037/tra0000210. Epub 2016 Oct 13.

    PubMed 27736138

  • Sangha O, Stucki G, Liang MH, Fossel AH, Katz JN. The Self-Administered Comorbidity Questionnaire: a new method to assess comorbidity for clinical and health services research. Arthritis Rheum. 2003 Apr 15;49(2):156-63. doi: 10.1002/art.10993.

    PubMed 12687505

  • Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.

    PubMed 2035047

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

Questions about this trial

What is this clinical trial studying?

A study testing Heart Rate Variability - Biofeedback (HRV-BF) and Health Promotion (HP) in people with Heart Rate Variability, run by University of California, Irvine at 3 sites 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 4 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Heart Rate Variability (time frame: Change Assessed during the resting 5-minute period at week 1 and week 8 sessions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897580, which also lists 17 linked publications.

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 9 Jun 2023.

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