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

NCT05897580 | Completed

• 1 other identifier: 20216820
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Rate Variability

Keywords

heart rate variability; mental health; anxiety; depression; PTSD

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate Variability

  Commercially available, medical grade photodetector (photoplethysmography or PPG) sensor and accompanying HRV-BF software application (EmWave Pro Plus, HeartMath) will be used to collect interbeat interval data to produce standard measures of HRV including time-domain measures of SDNN (standard deviation of N-to-N intervals) and RMSSD (Root mean square of successive differences between normal heart beats). Both SDNN and RMSSD are measured in milliseconds (ms). RMSSD is most reflective of vagal tone and is our primary outcome measure.

  Change Assessed during the resting 5-minute period at week 1 and week 8 sessions

Secondary Outcomes (7)

• Mental Health Status

  Baseline and 8 weeks

• Anxiety Symptoms

  Baseline and 8 weeks

• Depression Symptoms

  Baseline and 8 weeks

• Post Traumatic Stress Disorder (PTSD)

  Baseline and 8 weeks

• Drug and Alcohol Use

  Baseline and 8 weeks

Other Outcomes (1)

• Social Support

  Baseline and 8 weeks

Study Arms (2)

Heart Rate Variability-Biofeedback (HRV-BF)

EXPERIMENTAL

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.

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

Health Promotion (HP)

ACTIVE COMPARATOR

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.

Behavioral: Health Promotion (HP)

Interventions

Heart Rate Variability - Biofeedback (HRV-BF) BEHAVIORAL

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.

Heart Rate Variability-Biofeedback (HRV-BF)

Health Promotion (HP) BEHAVIORAL

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.

Health Promotion (HP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (3)

Amity Foundation, Los Angeles

Los Angeles, California, 90007, United States

Location

Downtown Women Center, Los Angeles

Los Angeles, California, 90013, United States

Location

Los Angeles Christian Health Centers (LACHC)

Los Angeles, California, 90013, United States

Location

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MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: 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

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 9, 2023
• Study Start: February 22, 2022
• Primary Completion: June 21, 2022
• Study Completion: October 21, 2022
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)