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Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial

A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05454657
Enrollment
120
Registered
2022-07-12
Start date
2023-01-04
Completion date
2025-07-31
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

Keywords

Heart rate variability biofeedback, Just in time, Autonomic nervous system, Substance use disorder, Addiction recovery

Brief 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.

Detailed description

Alcohol and other drug use (AOD) lapses in early substance use disorder (SUD) recovery typically arise from interactions between aversive affective states and stressors that together elicit urges to use. A central goal of first-line cognitive-behavioral SUD treatments is to strengthen affective and cognitive control to increase individuals' ability to override impulses to use AOD. Yet certain automatic physiological processes compromised by SUD dynamically interact with internal affective states and environmental cues to undermine effortful cognitive control and outcompete cognitive goals to avoid substance use. 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.

Interventions

DEVICEHeart 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 may include any outpatient substance use disorder treatment or mutual-help group participation.

Sponsors

Colorado State University
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Heart rate variability biofeedback + treatment as usual vs. treatment as usual only

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥18 years of age * 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

* Medical history of severe cardiac arrhythmia * Active psychosis

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate Variability Biofeedback Engagement8 weeksNumber 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
Day-level Negative Affect8 weeksAverage day-level score reported; Range = 0-10; higher values denote greater negative affect
Day-level Positive Affect8 weeksAverage day-level score reported; Range = 0-10; higher values denote greater positive affect
Day-level Craving8 weeksAverage day-level score reported; Range = 0-10; higher values denote greater craving
Day-level Substance Use8 weeksPercent participants reporting any day-level substance use
8-week Substance Use8 weeksMean percent days abstinent over the 8-week intervention period
Odds Ratio of Within-day Association Between AOD Craving and AOD Use8 weeksWithin-day association between alcohol and other drug (AOD) craving earlier in the day and the odds of AOD use later that same day

Secondary

MeasureTime frameDescription
Change Craving8 weeksChange in craving measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).
Change Positive Affect8 weeksChange in positive affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).
Change Negative Affect8 weeksChange in negative affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).

Countries

United States

Participant flow

Recruitment details

This was a phase II, randomized clinical trial involving 8 weeks of outpatient treatment. Enrollment occurred virtually in the US from January 4 2023 to June 2024. Of 238 potential participants assessed, 120 treatment-seeking participants with an SUD were randomized.

Pre-assignment details

All enrolled participants were assigned to a group.

Participants by arm

ArmCount
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.
65
Treatment as Usual Only
The control group participated in 8 weeks of treatment as usual only.
50
Total115

Baseline characteristics

CharacteristicTotalTreatment as Usual OnlyHeart Rate Variability Biofeedback + Treatment as Usual
Age, Continuous46.18 Years
STANDARD_DEVIATION 11.59
46.18 Years
STANDARD_DEVIATION 11.04
46.18 Years
STANDARD_DEVIATION 12.08
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants6 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
105 Participants44 Participants61 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety 6a16.26 Units on a scale
STANDARD_DEVIATION 5.5
16.35 Units on a scale
STANDARD_DEVIATION 5.19
16.20 Units on a scale
STANDARD_DEVIATION 5.76
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression 6a14.28 Units on a scale
STANDARD_DEVIATION 6.06
13.72 Units on a scale
STANDARD_DEVIATION 5.47
14.71 Units on a scale
STANDARD_DEVIATION 6.48
Perceived Stress Scale14.56 Units on a scale
STANDARD_DEVIATION 3.12
14.20 Units on a scale
STANDARD_DEVIATION 3.3
14.83 Units on a scale
STANDARD_DEVIATION 2.97
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants2 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
11 Participants4 Participants7 Participants
Race (NIH/OMB)
More than one race
4 Participants0 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
95 Participants44 Participants51 Participants
Sex: Female, Male
Female
69 Participants29 Participants40 Participants
Sex: Female, Male
Male
46 Participants21 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 700 / 50
other
Total, other adverse events
0 / 700 / 50
serious
Total, serious adverse events
0 / 700 / 50

Outcome results

Primary

8-week Substance Use

Mean percent days abstinent over the 8-week intervention period

Time frame: 8 weeks

Population: An additional three participants were excluded from the within-treatment EMA analyses because they completed \<10% of surveys (final within treatment n=112; 64 experimental; 48 controls).

ArmMeasureValue (MEAN)Dispersion
Heart Rate Variability Biofeedback + Treatment as Usual8-week Substance Use91.79 percentage of days abstinentStandard Deviation 18.03
Treatment as Usual Only8-week Substance Use90.33 percentage of days abstinentStandard Deviation 16.99
Comparison: Two-sample t test with unequal variancesp-value: 0.6695% CI: [-8.07, 5.13]t-test, 2 sided
Primary

Day-level Craving

Average day-level score reported; Range = 0-10; higher values denote greater craving

Time frame: 8 weeks

Population: An additional three participants were excluded from the within-treatment EMA analyses because they completed \<10% of surveys (final within treatment n=112; 64 experimental; 48 controls).

ArmMeasureValue (MEAN)Dispersion
Heart Rate Variability Biofeedback + Treatment as UsualDay-level Craving2.32 Scores on a scaleStandard Deviation 2.65
Treatment as Usual OnlyDay-level Craving2.25 Scores on a scaleStandard Deviation 2.77
Comparison: To test the effect of HRVB vs. control on craving, a multilevel model was estimated where study day predicted mean craving that same day (L1; within-person), while controlling for day-of-the-week. At Level 2 (between-person), treatment condition and sex were included as predictors of craving. The focal effects were the main effect of treatment condition (L2) and cross-level interactions between study day (L1) and treatment condition (L2) predicting daily craving.p-value: <0.0595% CI: [-0.026, -0.014]Mixed Models Analysis
Primary

Day-level Negative Affect

Average day-level score reported; Range = 0-10; higher values denote greater negative affect

Time frame: 8 weeks

Population: An additional three participants were excluded from the within-treatment EMA analyses because they completed \<10% of surveys (final within treatment n=112; 64 experimental; 48 controls).

ArmMeasureValue (MEAN)Dispersion
Heart Rate Variability Biofeedback + Treatment as UsualDay-level Negative Affect2.96 Scores on a scaleStandard Deviation 2.07
Treatment as Usual OnlyDay-level Negative Affect3.36 Scores on a scaleStandard Deviation 2.13
Comparison: To test the effect of HRVB vs control on negative affect, a multilevel model was estimated where study day predicted mean negative affect that same day (L1; within-person), while controlling for day-of-the-week. At Level 2 (between-person), treatment condition and sex were included as predictors of negative affect. The focal effects were the main effect of treatment condition (L2) and cross-level interactions between study day (L1) and treatment condition (L2) predicting daily negative affect.p-value: <0.0595% CI: [-0.015, -0.008]Mixed Models Analysis
Primary

Day-level Positive Affect

Average day-level score reported; Range = 0-10; higher values denote greater positive affect

Time frame: 8 weeks

Population: An additional three participants were excluded from the within-treatment EMA analyses because they completed \<10% of surveys (final within treatment n=112; 64 experimental; 48 controls).

ArmMeasureValue (MEAN)Dispersion
Heart Rate Variability Biofeedback + Treatment as UsualDay-level Positive Affect5.26 Scores on a scaleStandard Deviation 1.97
Treatment as Usual OnlyDay-level Positive Affect5.02 Scores on a scaleStandard Deviation 1.92
Comparison: To test the effect of HRVB vs. control on positive affect, a multilevel model was estimated where study day predicted mean positive affect that same day (L1; within-person), while controlling for day-of-the-week. At Level 2 (between-person), treatment condition and sex were included as predictors of positive affect. The focal effects were the main effect of treatment condition (L2) and cross-level interactions between study day (L1) and treatment condition (L2) predicting daily positive affect.p-value: <0.0595% CI: [-0.677, 0.857]Mixed Models Analysis
Primary

Day-level Substance Use

Percent participants reporting any day-level substance use

Time frame: 8 weeks

Population: An additional three participants were excluded from the within-treatment EMA analyses because they completed \<10% of surveys (final within treatment n=112; 64 experimental; 48 controls).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Heart Rate Variability Biofeedback + Treatment as UsualDay-level Substance Use6 Participants
Treatment as Usual OnlyDay-level Substance Use5 Participants
Comparison: To test the effect of HRVB vs. control on AOD use A Bayesian logistic multilevel model was estimated where study day predicted AOD use that same day (L1; within-person), while controlling for day-of-the-week. At Level 2 (between-person), treatment condition and sex were included as predictors of AOD use. The focal effects were the main effect of treatment condition (L2) and cross-level interactions between study day (L1) and treatment condition (L2) predicting daily AOD use.p-value: <0.0595% CI: [0.245, 0.543]Mixed Models Analysis
Primary

Heart Rate Variability Biofeedback Engagement

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

Time frame: 8 weeks

Population: An additional three participants were excluded from the within-treatment EMA analyses because they completed \<10% of surveys (final within treatment n=112; 64 experimental; 48 controls).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Heart Rate Variability Biofeedback + Treatment as UsualHeart Rate Variability Biofeedback Engagement15 Participants
Treatment as Usual OnlyHeart Rate Variability Biofeedback Engagement0 Participants
Primary

Odds Ratio of Within-day Association Between AOD Craving and AOD Use

Within-day association between alcohol and other drug (AOD) craving earlier in the day and the odds of AOD use later that same day

Time frame: 8 weeks

Population: To test the moderating effects of HRVB on the within-day associations between craving and AOD use, we estimated a Bayesian logistic multilevel model with an unstructured variance-covariance matrix where craving earlier in the day predicted AOD use later that same day (L1; lagged within-person). The focal effect of interest was a cross-level interaction between craving earlier in the day (L1) and treatment condition (L2) predicting AOD use later that same day.

ArmMeasureValue (NUMBER)
Heart Rate Variability Biofeedback + Treatment as UsualOdds Ratio of Within-day Association Between AOD Craving and AOD Use0.84 Odds ratio
Treatment as Usual OnlyOdds Ratio of Within-day Association Between AOD Craving and AOD Use1.00 Odds ratio
Secondary

Change Craving

Change in craving measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).

Time frame: 8 weeks

Secondary

Change Negative Affect

Change in negative affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).

Time frame: 8 weeks

Secondary

Change Positive Affect

Change in positive affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).

Time frame: 8 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026