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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Rate Variability

Intervention / Treatment
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* Behavioral: Heart Rate Variability - Biofeedback (HRV-BF)
* Behavioral: Health Promotion (HP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart Rate Variability-Biofeedback (HRV-BF)<br>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)<br>* 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.<br>|
| Active Comparator: Health Promotion (HP)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart rate variability, mental health, anxiety, depression, PTSD