跳至主要内容
临床试验/NCT05454657
NCT05454657已完成不适用

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

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Heart Rate Variability Biofeedback Engagement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥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

排除标准

  • Medical history of severe cardiac arrhythmia
  • Active psychosis

结局指标

主要结局

Heart Rate Variability Biofeedback Engagement

时间窗: 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

时间窗: 8 weeks

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

Day-level Positive Affect

时间窗: 8 weeks

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

Day-level Craving

时间窗: 8 weeks

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

Day-level Substance Use

时间窗: 8 weeks

Percent participants reporting any day-level substance use

8-week Substance Use

时间窗: 8 weeks

Mean percent days abstinent over the 8-week intervention period

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

时间窗: 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

次要结局

  • Change Negative Affect(8 weeks)
  • Change Craving(8 weeks)
  • Change Positive Affect(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Eddie

Assistant Professor

Massachusetts General Hospital

研究点 (2)

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