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NCT05897580 · ClinicalTrials.gov registry record · NA
Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness
A NA study, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05897580: Completed NA study, sponsored by University of California, Irvine.
NCT05897580 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05897580, a NA study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
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 t
Interventions
- BEHAVIORAL Heart Rate Variability - Biofeedback (HRV-BF)
- BEHAVIORAL Health Promotion (HP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-02-22 |
| Est. Completion | 2022-10-21 |
| Phase | NA |
What the finished NCT05897580 record still lists
NCT05897580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Heart Rate Variability - Biofeedback (HRV-BF) is the first listed.
NCT05897580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05897580 about?
NCT05897580 is a clinical study titled "Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness". 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 to...
What is the current status of trial NCT05897580?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-02-22. Estimated completion is 2022-10-21.
What interventions are being tested in trial NCT05897580?
The interventions under investigation include: Heart Rate Variability - Biofeedback (HRV-BF) (BEHAVIORAL), Health Promotion (HP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05897580?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05897580's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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