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

University of California Irvine (UCI)

Status: Completed

Conditions: Heart Rate Variability

Treatments: Behavioral: Heart Rate Variability - Biofeedback (HRV-BF); Behavioral: Health Promotion (HP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05897580

20216820

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Heart Rate Variability-Biofeedback (HRV-BF)

Experimental group

Description:

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.

Treatment:

Behavioral: Heart Rate Variability - Biofeedback (HRV-BF)

Health Promotion (HP)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Promotion (HP)