Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial
NCT ID: NCT05454657
Last Updated: 2025-12-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2023-01-04
2025-07-31
Brief Summary
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Detailed Description
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Heart rate variability biofeedback (HRVB) is a biobehavioral intervention involving rhythmic breathing at resonance frequency (RF) that stimulates the body's baroreflex mechanism to offset these psychophysiological deficits. The autonomic normalization effected by RF breathing is thought to bolster cognitive control efforts by interrupting or dampening automatic-visceral reactions that can undermine treatment gains, and in doing so support better decision-making, motivation, reductions in craving, and shifts in attention allocation.
Previous studies of HRVB have focused on positive behavioral effects that accrue over a series of weeks or months, rather than 'in-the-moment'. These chronic behavior changes, although clinically valuable, are labor and time intensive to elicit, reducing the likelihood of large-scale uptake of the intervention. Further, first-generation HRVB's regular daily practice model is likely to only partially mitigate the intense momentary bouts of emotion dysregulation that are triggers for AOD use in those in early SUD recovery. In contrast, recent studies have demonstrated that a brief exposure to RF breathing in anticipation of psychosocial stress, or during induced stress, helps to control physiological arousal, reduce state anxiety, and improve cognitive performance. It is posited that such bursts of in-the-moment HRVB practice could serve as a potent SUD treatment tool that helps individuals self-regulate emotions when needed most.
Recent advances in the field have given rise to small, lightweight, wearable biosensors that can allow wearers to do HRVB on-the-go. These devices also have the capacity to function as a just-in-time intervention by prompting in-the-moment HRVB practice when autonomic hyperarousal is detected, to buffer salient triggers and urges to use AOD. This research builds on a body of preliminary work speaking to HRVB's potential as an addendum to first-line SUD treatments by exploring for the first time in this disorder this second-generation, ambulatory, HRVB technology. Specific aims of this research include, 1) assessing ambulatory HRVB's uptake by individuals with SUD, 2) testing day-level effects of in-the-moment HRVB practice on affective states and substance use, and 3) testing the accumulative effects of scheduled daily HRVB practice, in-the-moment HRVB practice, and their combination, on substance use.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Heart rate variability biofeedback + treatment as usual
The experimental group participated in 8 weeks of Heart Rate Variability Biofeedback (HRVB) practice using the Lief HRVB Smart Patch and smartphone app + treatment as usual. Participants were asked to, 1) wear the Lief Smart Patch for at least 8 hours per day, 2) do 10mins of scheduled HRVB practice daily, and 3) do at least 5mins per day of HRVB practice in-the-moment when negative affect/craving arose, or in response to just-in-time prompts to do brief bursts of HRVB when the device sensed autonomic arousal indicative of stress.
Heart rate variability biofeedback + treatment as usual
Heart rate variability biofeedback is a biobehavioral intervention involving rhythmic breathing at resonance frequency (RF) that stimulates the baroreflex and increases heart rate variability.
Treatment as usual only
Treatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation.
Treatment as usual only
The control group participated in 8 weeks of treatment as usual only.
Treatment as usual only
Treatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation.
Interventions
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Heart rate variability biofeedback + treatment as usual
Heart rate variability biofeedback is a biobehavioral intervention involving rhythmic breathing at resonance frequency (RF) that stimulates the baroreflex and increases heart rate variability.
Treatment as usual only
Treatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation.
Eligibility Criteria
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Inclusion Criteria
* Own a smartphone
* English proficiency
* DSM 5 diagnosis of substance use disorder
* In the first year of a current substance use disorder recovery attempt with a goal of total alcohol and other drug abstinence
Exclusion Criteria
* Active psychosis
18 Years
ALL
No
Sponsors
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Colorado State University
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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David Eddie
Assistant Professor
Principal Investigators
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David Eddie, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Eddie D, Nguyen M, Zeng K, Mei S, Emery N. Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1177-1185. doi: 10.1001/jamapsychiatry.2025.2700.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2022P001496
Identifier Type: -
Identifier Source: org_study_id