Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness
Condition: Heart Rate Variability
Study type: Interventional

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.
    

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.
    

Intervention name(s): Heart Rate Variability - Biofeedback (HRV-BF); Health Promotion (HP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: heart rate variability; mental health; anxiety; depression; PTSD