Substance Use Disorders
Conditions
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
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
Study design
Intervention model description
Heart rate variability biofeedback + treatment as usual vs. treatment as usual only
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability Biofeedback Engagement | 8 weeks | 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 |
| Day-level Negative Affect | 8 weeks | Average day-level score reported; Range = 0-10; higher values denote greater negative affect |
| Day-level Positive Affect | 8 weeks | Average day-level score reported; Range = 0-10; higher values denote greater positive affect |
| Day-level Craving | 8 weeks | Average day-level score reported; Range = 0-10; higher values denote greater craving |
| Day-level Substance Use | 8 weeks | Percent participants reporting any day-level substance use |
| 8-week Substance Use | 8 weeks | Mean percent days abstinent over the 8-week intervention period |
| Odds Ratio of Within-day Association Between AOD Craving and AOD Use | 8 weeks | Within-day association between alcohol and other drug (AOD) craving earlier in the day and the odds of AOD use later that same day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Craving | 8 weeks | Change in craving measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM). |
| Change Positive Affect | 8 weeks | Change in positive affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM). |
| Change Negative Affect | 8 weeks | Change 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
| Arm | Count |
|---|---|
| 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 |
| Total | 115 |
Baseline characteristics
| Characteristic | Total | Treatment as Usual Only | Heart Rate Variability Biofeedback + Treatment as Usual |
|---|---|---|---|
| Age, Continuous | 46.18 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 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants | 44 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety 6a | 16.26 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 6a | 14.28 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 Scale | 14.56 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 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 95 Participants | 44 Participants | 51 Participants |
| Sex: Female, Male Female | 69 Participants | 29 Participants | 40 Participants |
| Sex: Female, Male Male | 46 Participants | 21 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 50 |
| other Total, other adverse events | 0 / 70 | 0 / 50 |
| serious Total, serious adverse events | 0 / 70 | 0 / 50 |
Outcome results
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Rate Variability Biofeedback + Treatment as Usual | 8-week Substance Use | 91.79 percentage of days abstinent | Standard Deviation 18.03 |
| Treatment as Usual Only | 8-week Substance Use | 90.33 percentage of days abstinent | Standard Deviation 16.99 |
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Rate Variability Biofeedback + Treatment as Usual | Day-level Craving | 2.32 Scores on a scale | Standard Deviation 2.65 |
| Treatment as Usual Only | Day-level Craving | 2.25 Scores on a scale | Standard Deviation 2.77 |
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Rate Variability Biofeedback + Treatment as Usual | Day-level Negative Affect | 2.96 Scores on a scale | Standard Deviation 2.07 |
| Treatment as Usual Only | Day-level Negative Affect | 3.36 Scores on a scale | Standard Deviation 2.13 |
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Rate Variability Biofeedback + Treatment as Usual | Day-level Positive Affect | 5.26 Scores on a scale | Standard Deviation 1.97 |
| Treatment as Usual Only | Day-level Positive Affect | 5.02 Scores on a scale | Standard Deviation 1.92 |
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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Rate Variability Biofeedback + Treatment as Usual | Day-level Substance Use | 6 Participants |
| Treatment as Usual Only | Day-level Substance Use | 5 Participants |
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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heart Rate Variability Biofeedback + Treatment as Usual | Heart Rate Variability Biofeedback Engagement | 15 Participants |
| Treatment as Usual Only | Heart Rate Variability Biofeedback Engagement | 0 Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heart Rate Variability Biofeedback + Treatment as Usual | Odds Ratio of Within-day Association Between AOD Craving and AOD Use | 0.84 Odds ratio |
| Treatment as Usual Only | Odds Ratio of Within-day Association Between AOD Craving and AOD Use | 1.00 Odds ratio |
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
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
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