- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05454657
A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Eddie, Ph.D.
- Phone Number: 617-643-9194
- Email: deddie@mgh.harvard.edu
Study Contact Backup
- Name: Marina Nguyen, B.A.
- Phone Number: 617-732-8140
- Email: mnguyen64@mgh.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114-4714
- Recruiting
- Massachusetts General Hospital
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Contact:
- Phone Number: 617-643-9194
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heart rate variability biofeedback + treatment as usual
The experimental group will participate in 8 weeks of heart rate variability biofeedback practice using the Lief heart rate variability biofeedback Smart Patch and smartphone app + treatment as usual.
Participants will be asked to, 1) wear the Lief Smart Patch for at least 8 hours per day, 2) do 15mins of scheduled heart rate variability biofeedback practice daily, and 3) use it as needed in response to negative affect in-the-moment.
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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.
Treatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation.
|
Active Comparator: Treatment as usual only
The control group will participate in 8 weeks of treatment as usual only.
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Treatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability biofeedback engagement
Time Frame: 8 weeks
|
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
|
Day-level substance use
Time Frame: 8 weeks
|
Day-level substance use measured by ecological momentary assessment
|
8 weeks
|
Day-level negative affect
Time Frame: 8 weeks
|
Day-level negative affect measured by ecological momentary assessment
|
8 weeks
|
Day-level craving
Time Frame: 8 weeks
|
Day-level craving measured by ecological momentary assessment
|
8 weeks
|
Day-level positive affect
Time Frame: 8 weeks
|
Day-level positive affect measured by ecological momentary assessment
|
8 weeks
|
8-week substance use
Time Frame: 8 weeks
|
Substance use over the 8-week intervention period expressed as percent days abstinent measured by ecological momentary assessment
|
8 weeks
|
Change negative affect
Time Frame: 8 weeks
|
Change in negative affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).
|
8 weeks
|
Change craving
Time Frame: 8 weeks
|
Change in craving measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).
|
8 weeks
|
Change positive affect
Time Frame: 8 weeks
|
Change in positive affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Eddie, Ph.D., Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022P001496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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