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NCT05454657 · ClinicalTrials.gov registry record · NA
Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT05454657: Completed NA study, sponsored by Massachusetts General Hospital.
NCT05454657 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05454657, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
Heart rate variability biofeedback (HRVB) is an biobehavioral intervention involving rhythmic breathing at resonance frequency that stimulates cardiovascular regulatory systems to help individuals better regulate affect and bolster cognitive control. This intervention has already shown its potential as a substance use disorder (SUD) treatment tool, but practical limitations of its accessibility, labor intensiveness, and cost have previously prevented this intervention from going to scale. Second-generation, ambulatory HRVB technology, however, has overcome these limitations and now allows patients to practice HRVB in-the-moment when its needed most. This study is testing the efficacy of second-generation, ambulatory HRVB for the first time with individuals with SUD.
Primary Outcome
Number of participants with ≥50% daily-practice adherence to the study practice target of 15 minutes per day, inclusive of scheduled and self-initiated HRVB practice
Interventions
- DEVICE Heart rate variability biofeedback + treatment as usual
- BEHAVIORAL Treatment as usual only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-01-04 |
| Est. Completion | 2025-07-31 |
| Phase | NA |
What the finished NCT05454657 record still lists
NCT05454657 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Heart rate variability biofeedback + treatment as usual is the first listed.
NCT05454657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05454657 about?
NCT05454657 is a clinical study titled "Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial". Heart rate variability biofeedback (HRVB) is an biobehavioral intervention involving rhythmic breathing at resonance frequency that stimulates cardiovascular regulatory systems to help individuals better regulate affect and bolster cognitive control. This intervention has already shown its potential...
What is the current status of trial NCT05454657?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2023-01-04. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT05454657?
The interventions under investigation include: Heart rate variability biofeedback + treatment as usual (DEVICE), Treatment as usual only (BEHAVIORAL).
Who is sponsoring clinical trial NCT05454657?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05454657's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 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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