Clinical trial NCT05454657: A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder
Official title: A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use Disorders
Keywords: Heart rate variability biofeedback
Just in time
Autonomic nervous system
Substance use disorder
Addiction recovery
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Colorado State University
First posted: 2022-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Heart rate variability biofeedback + treatment as usual vs. treatment as usual only
Primary purpose: TREATMENT

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 interaction, on substance use.

Eligibility criteria: 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

Primary outcomes:
measure: Heart rate variability biofeedback engagement
timeFrame: 8 weeks
measure: Day-level substance use
timeFrame: 8 weeks
measure: Day-level negative affect
timeFrame: 8 weeks
measure: Day-level craving
timeFrame: 8 weeks
measure: Day-level positive affect
timeFrame: 8 weeks
measure: 8-week substance use
timeFrame: 8 weeks
measure: Change negative affect
timeFrame: 8 weeks
measure: Change craving
timeFrame: 8 weeks
measure: Change positive affect
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David Eddie, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: