Open Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Intervention Feasibility: Participant Attendance
研究概览
简要总结
The purpose of the study is to conduct an open trial examining the feasibility and acceptability of an adapted heart rate variability biofeedback and smoking cessation treatment that was using a primarily virtual remote intervention.
详细描述
The present investigation is an open trial investigating the feasibility and acceptability of heart rate variability biofeedback smoking cessation treatment (HRVB-SCT) for individuals who smoke cigarettes. Significant findings will also support the expansion of HRVB as a transdiagnostic treatment adjunct that alters cardiac vagal functioning to promote emotional and behavioral regulation, changing the status quo of cognitive-behavioral intervention approaches and decreasing the health and economic burden of smokers who suffer from emotional distress.
The goals are to: (a) assess the feasibility and acceptability of the HRVB-SCT intervention (b) assess the efficacy of the intervention in modifying smoking behavior and emotional distress; and (c) collect additional information to inform a subsequent randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open trial with all participants receiving the experimental intervention (HRVB) in addition to smoking cessation therapy and nicotine replacement therapy patch.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-50
- •Smoking ≥ 5 cigarettes, daily, for at least two years
- •Expired carbon monoxide analysis of breath sample ≥8 ppm
- •A score of > 5 on the Readiness to Quit Ladder (i.e., desire to quit smoking within the next 6 months)
- •Ability to read and speak English fluently
- •Computer and Smartphone proficient
排除标准
- •Use of other tobacco or nicotine products for recreation or to aid in cessation or use of medication to aid in smoking cessation or currently receiving counseling for smoking cessation
- •Endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation
- •Self-reported pending legal issue with potential to result in incarceration
- •Plan to move from the New Brunswick, New Jersey area within the next 6 months
- •Inability to provide written informed consent
- •Current evidence of another substance use disorder
- •Severe visual or hearing impairments
- •Self-reported medical condition or medication use that may be contraindicated for participation in heart rate variability biofeedback training or confound autonomic parameters: Being overweight or obese (i.e., body mass index > 35); Severe asthma or breathing problems (e.g., chronic obstructive pulmonary disease, emphysema, bronchitis); currently pregnant or lactating or plans to become pregnant in the next 4 months; Autoimmune disorder (e.g., multiple sclerosis; under or overactive thyroid); Neurodegenerative disorder (e.g., Alzheimer's disease, Parkinson's disease); Current use of a psychotropic medication or use of other medication that may affect the cardiovascular system (e.g., mood stabilizers, anti-psychotics, monoamine oxidase inhibitors, tricyclics, beta blockers, benzodiazepines; patients taking selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors will be enrolled if on a stable regimen for at least 6 weeks); History of heart murmur or arrhythmia; Pacemaker or other implanted cardiac devices; Heart disease; or Abnormal heart or respiratory parameters including respiration rate > 20 breaths per minute, extra systoles, or hypertension (e.g., blood pressure reading ≥ 140/90; this may be determined following baseline assessment. Importantly, the presence of any of these exclusion factors, if unknown to the participant would not put them at any risk if they participated in the study, it would simply make the cardiovascular data more difficult (if not impossible) to process and interpret, and
- •Self-reported medical issues of potential concern to nicotine patch users (i.e., unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days
研究组 & 干预措施
Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)
All participants in this open trial will receive individualized training in resonance breathing using biofeedback to help improve self-regulation (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT).
干预措施: Cognitive-Behavioral Smoking Cessation (Behavioral)
Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)
All participants in this open trial will receive individualized training in resonance breathing using biofeedback to help improve self-regulation (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT).
干预措施: Heart Rate Variability Biofeedback (Biological)
Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)
All participants in this open trial will receive individualized training in resonance breathing using biofeedback to help improve self-regulation (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT).
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Intervention Feasibility: Participant Attendance
时间窗: 6 weeks
Number of intervention sessions attended out of 7 possible sessions.
Intervention Feasibility: Participant Practice Adherence
时间窗: 6 weeks
Time (in minutes) spent practicing the breathing intervention
Intervention Feasibility: Participant Ratings of Effectiveness
时间窗: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)
Effectiveness was assessed via self-report ratings on four items assessing the intervention in terms of helping them quit and manage emotional distress, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived intervention efficacy.
Intervention Feasibility: Participant Ratings of Ease of the Intervention
时间窗: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)
Ease of the Intervention was assessed via self-report ratings on three items assessing ease of use and fit into daily lifestyle, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived ease of the intervention and fit into daily lifestyle.
Intervention Feasibility: Interventionist Ratings of Technical Issues
时间窗: 6 weeks
The intervention used several pieces of technology, including remote session delivery via Zoom, smartphone assisted carbon monoxide (CO) monitor and HRVB devices, remote survey administration, as well as in-person use of biofeedback and physiological monitoring equipment. Technological limitations were assessed via self-report items documenting incidences of technical issues during intervention sessions and their related effects on intervention delivery. Items include Yes/No and open-text responses.
Intervention Acceptability: Participant Rating of Satisfaction and Liking
时间窗: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)
Satisfaction and liking will be assessed via self-report items regarding satisfaction with learning the intervention, liking the intervention, breathing techniques, nicotine replacement, and recommending the intervention to others. Items are rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater satisfaction and liking of the intervention and greater perceived intervention acceptability.
Intervention Feasibility: Participant Ratings of Appropriateness
时间窗: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)
Appropriateness was assessed via self-report ratings on two items assessing the intervention in terms of comprehension and fit, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived intervention appropriateness.
次要结局
- Changes in Total Emotional Distress(Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU))
- Changes in Smoking Behavior: Quit Day Abstinence(Week 3 (i.e., Quit Date))
- Changes in Smoking Behavior: Sustained Smoking Cessation(Week 16 (i.e., 3-MFU))
- Changes in Smoking Behavior: Reduced Smoking Rate(Week 0, Week 3, Week 5, Week 6, and Week 16 (i.e., Baseline, Quit Date, 2-Weeks Post-Quit, 1-Month Post-Quit, 3-Month follow up))
研究者
Teresa M. Leyro, Ph.D.
Principal Investigator
Rutgers, The State University of New Jersey