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

Heart Rate Variability Clinical Trial

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

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Rate Variability

• NCT number: NCT05897580
• Study type: Interventional
• Source: University of California, Irvine
• Status: Completed
• Phase: N/A
• Start date: February 22, 2022
• Completion date: October 21, 2022