Last reviewed · How we verify
NCT05897580: HRV-BF
Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness
NA trial testing Heart Rate Variability - Biofeedback (HRV-BF) in Heart Rate Variability in 40 participants. Completed in 21 October 2022.
21 June 2022
Quick facts
| Lead sponsor | University of California, Irvine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 22 February 2022 |
| Primary completion | 21 June 2022 |
| Estimated completion | 21 October 2022 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Heart Rate Variability - Biofeedback (HRV-BF)
- Health Promotion (HP)
Conditions studied
- Heart Rate Variability — all drugs for Heart Rate Variability →
Sponsor
University of California, Irvine
Who can join
Adults 18 to 75, any sex, with Heart Rate Variability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05897580
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of California, Irvine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05897580 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, Irvine
- Last refreshed: 9 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05897580.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing