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

Heart Rate Variability Clinical Trial

— HRV-BF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897580
• Other study ID #: 20216820
• Status: Completed
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: October 21, 2022

Study information

• Verified date: June 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Rate Variability

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (17)

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Support	Social support was measured by the Medical Outcome Study (MOS) Social Support Survey. The MOS is a 19-item instrument and includes four subscales: emotional and informational support; tangible support; positive social interaction; and affectionate support. The MOS uses a Likert-scale, with endpoints 1 (none of the time) to 5 (all of the time) that assesses availability of social support, with higher scores indicating more social support. An overall support index was also calculated.• Minimum = 0; Maximum = 100; Higher score means a better outcome.	Baseline and 8 weeks
Primary	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	Mental Health Status	Assessed by the Mental Health Inventory-5 (MHI-5) which has well-demonstrated reliability for detecting psychological disorders with reliabilities of .77 and .71 for women/men, respectively. Minimum = 5; Maximum = 30; Higher score means a better outcome.	Baseline and 8 weeks
Secondary	Anxiety Symptoms	Anxiety Symptoms were measured by the Generalized Anxiety Disorder -7, a self-report 7- item measure. Example items include "worrying too much about different things," and "trouble relaxing" (Endpoints 0=not at all; 3=nearly every day). Scores are summed. Severity of anxiety was determined with cut-off scores 5 (mild anxiety), 10 (moderate anxiety), and 15 (severe anxiety). Reliability a=0.87. Minimum = 0; Maximum = 21; Higher score means a worse outcome.	Baseline and 8 weeks
Secondary	Depression Symptoms	Depressive Symptoms were assessed by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a brief, 9 question depression module from the full 26-item PHQ. Each of the 9 items address the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria, rating them from "0" (not at all) to "3" (nearly every day). PHQ-9 not only makes criteria-based diagnoses of depressive disorders, but as well can determine severity, with scoring cut-offs for minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27) depression. Reliability of the PHQ-9 is a=0.89. Minimum = 0; Maximum = 27; Higher score means a worse outcome.	Baseline and 8 weeks
Secondary	Post Traumatic Stress Disorder (PTSD)	PTSD was measured by means of the Post Traumatic Stress Disorder Checklist-5 (PCL-C), a 17-item screener for PTSD with cut points for symptomatic vs non-symptomatic; scores correlate highly with the Clinician Administered PTSD scale, r = .93.70 The PCL-C has high levels of validity,71 test-retest reliability (r = .96), and high internal consistency (a = .97). The self-report rating scale is 0-4 for each symptom: "Not at All" to "Extremely" (0-80). 5-point change is a minimum threshold for determining a treatment response, while a 10-point change is a minimum threshold for determining a clinically meaningful treatment response. Minimum = 17; Maximum = 85; Higher score means a worse outcome.	Baseline and 8 weeks
Secondary	Drug and Alcohol Use	Drug and Alcohol Use was assessed by the Texas Christian University (TCU) Drug History Form. It records the frequency of use of 16 drugs used over 12 months, such as heroin and other opiates, street methadone, cocaine, crack, methamphetamine, etc. Yes/No to each drug was assessed for use vs dependency. The total score ranges from 0 - 9; higher scores (> 3) correspond to the DSM 4 drug dependence diagnosis. Minimum = 0; Maximum = 11; Higher score means a worse outcome.	Baseline and 8 weeks
Secondary	Physical Disease	Physical Diseases was assessed by the self-reported comorbidity index (SCQ) for medical problem, treatment, and limitations. PEH were asked to respond if they have chronic health conditions (e.g., heart disease, high blood pressure, diabetes, osteoarthritis). Responses include "yes or no". In a previous PEH sample (N=150), Cronbach's a = .91.; Physical Diseases was assessed by the self-reported comorbidity index (SCQ) for medical problem, treatment, and limitations. PEH were asked to respond if they have chronic health conditions (e.g., heart disease, high blood pressure, diabetes, osteoarthritis. Responses include "yes or no". In a previous PEH sample (N=150), Cronbach's a = .91. Minimum = 0; Maximum = 36; Higher score means a worse outcome.	Baseline and 8 weeks
Secondary	Assessing Evidence of Drug Use in Urine	Urinalysis: In addition, we conducted a urine assay which measures cannabis, methamphetamine, cocaine, and amphetamines. A five-panel Food and Drug Administration-approved urine test cup was used at baseline and 8 week follow-up. The test cup screened for metabolites of Amphetamines (1000 ng/mL), Cocaine (300 ng/mL), Methamphetamines (500 ng/mL), Opiates (2000 ng/mL), and Cannabis (THC) (50 ng/mL).	Baseline and 8 weeks