Clinical trial NCT05897580: Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness
Official title: Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Rate Variability
Keywords: heart rate variability
mental health
anxiety
depression
PTSD
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Heart Rate Variability
timeFrame: Change Assessed during the resting 5-minute period at week 1 and week 8 sessions
Secondary outcomes:
measure: Mental Health Status
timeFrame: Baseline and 8 weeks
measure: Anxiety Symptoms
timeFrame: Baseline and 8 weeks
measure: Depression Symptoms
timeFrame: Baseline and 8 weeks
measure: Post Traumatic Stress Disorder (PTSD)
timeFrame: Baseline and 8 weeks
measure: Drug and Alcohol Use
timeFrame: Baseline and 8 weeks
measure: Physical Disease
timeFrame: Baseline and 8 weeks
measure: Assessing Evidence of Drug Use in Urine
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Social Support
timeFrame: Baseline and 8 weeks
Locations:
city: Los Angeles
country: United States
facility: Amity Foundation, Los Angeles
state: California
city: Los Angeles
country: United States
facility: Downtown Women Center, Los Angeles
state: California
city: Los Angeles
country: United States
facility: Los Angeles Christian Health Centers (LACHC)
state: California
Study officials:
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