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

June 8, 2023 updated by: Adeline Nyamathi, University of California, Irvine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90013
        • Los Angeles Christian Health Centers (LACHC)
      • Los Angeles, California, United States, 90007
        • Amity Foundation, Los Angeles
      • Los Angeles, California, United States, 90013
        • Downtown Women Center, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heart Rate Variability-Biofeedback (HRV-BF)
Heart 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.
Behavioral: Heart Rate Variability - Biofeedback (HRV-BF)

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.
Active Comparator: Health Promotion (HP)
The 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.
Behavioral: Health Promotion (HP)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability
Time Frame: Change Assessed during the resting 5-minute period at week 1 and week 8 sessions
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.
Change Assessed during the resting 5-minute period at week 1 and week 8 sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health Status
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
Anxiety Symptoms
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
Depression Symptoms
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
Post Traumatic Stress Disorder (PTSD)
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
Drug and Alcohol Use
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
Physical Disease
Time Frame: Baseline and 8 weeks

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.
Baseline and 8 weeks
Assessing Evidence of Drug Use in Urine
Time Frame: Baseline and 8 weeks
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).
Baseline and 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Support
Time Frame: Baseline and 8 weeks
Social support was measured by the Medical Outcome Study (MOS) Social Support Survey. The MOS is a 19-item instrument and includes four subscales: emotional and informational support; tangible support; positive social interaction; and affectionate support. The MOS uses a Likert-scale, with endpoints 1 (none of the time) to 5 (all of the time) that assesses availability of social support, with higher scores indicating more social support. An overall support index was also calculated.• Minimum = 0; Maximum = 100; Higher score means a better outcome.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Actual)

June 21, 2022

Study Completion (Actual)

October 21, 2022

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20216820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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