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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454657
• Other study ID #: 2022P001496
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: July 2024

Study information

• Verified date: January 2023
• Source: Massachusetts General Hospital
• Contact: David Eddie, Ph.D.
• Phone: 617-643-9194
• Email: deddie[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Disease
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Device:
• 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 may include any outpatient substance use disorder treatment or mutual-help group participation.

Behavioral:
• Treatment as usual only
Treatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability biofeedback engagement	Heart rate variability biofeedback (HRVB) engagement reflected by HRVB practice time.; As a general benchmark of intervention uptake success, we will accept =50% engagement/adherence to scheduled practice (i.e., 15mins daily) with consideration given to both number of days practiced and time practiced each day.; We will also accept =50% in-the-moment practice as indicative of engagement/adherence, based on the ratio of just-in-time practice prompts responded to vs. ignored and the number of days participants engaged in in-the-moment HRVB practice.	8 weeks
Primary	Day-level substance use	Day-level substance use measured by ecological momentary assessment	8 weeks
Primary	Day-level negative affect	Day-level negative affect measured by ecological momentary assessment	8 weeks
Primary	Day-level craving	Day-level craving measured by ecological momentary assessment	8 weeks
Primary	Day-level positive affect	Day-level positive affect measured by ecological momentary assessment	8 weeks
Primary	8-week substance use	Substance use over the 8-week intervention period expressed as percent days abstinent measured by ecological momentary assessment	8 weeks
Primary	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).	8 weeks
Primary	Change craving	Change in craving measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).	8 weeks
Primary	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).	8 weeks