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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DEVICE Heart rate variability biofeedback + treatment as usual
  • BEHAVIORAL Treatment as usual only

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-01-04
Est. Completion 2025-07-31
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT05454657

The ClinicalTrials.gov registry entry for NCT05454657 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Heart rate variability biofeedback + treatment as usual is the first listed.

NCT05454657 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.