Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness
NCT ID: NCT05897580
Last Updated: 2023-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-02-22
2022-10-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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University of California, Irvine
OTHER
Responsible Party
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Adeline Nyamathi
Distinguished Professor
Locations
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Amity Foundation, Los Angeles
Los Angeles, California, United States
Downtown Women Center, Los Angeles
Los Angeles, California, United States
Los Angeles Christian Health Centers (LACHC)
Los Angeles, California, United States
Countries
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References
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Lehrer P, Kaur K, Sharma A, Shah K, Huseby R, Bhavsar J, Sgobba P, Zhang Y. Heart Rate Variability Biofeedback Improves Emotional and Physical Health and Performance: A Systematic Review and Meta Analysis. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):109-129. doi: 10.1007/s10484-020-09466-z.
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Sangha O, Stucki G, Liang MH, Fossel AH, Katz JN. The Self-Administered Comorbidity Questionnaire: a new method to assess comorbidity for clinical and health services research. Arthritis Rheum. 2003 Apr 15;49(2):156-63. doi: 10.1002/art.10993.
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Other Identifiers
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20216820
Identifier Type: -
Identifier Source: org_study_id
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