Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intervention Feasibility: Participant Attendance
研究概览
简要总结
Open trial of heart rate variability biofeedback as an adjunct to individualized smoking cessation counseling (SCT) plus transdermal nicotine replacement patch (NRT) in smokers with elevated emotional distress.
详细描述
The investigators propose to develop and pilot test heart rate variability biofeedback (HRVB) for smokers with elevated emotional distress as an adjunct to individual smoking cessation counseling (SCT) and transdermal nicotine patch (NRT). In this open trial, all participants received the active intervention. Findings will be used to refine the protocol in advance of a subsequent Phase III 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 what will become the 'active intervention' in a subsequent randomized clinical trial.
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
- •Smoking ≥5 cigarettes, daily, for at least two years
- •expired carbon monoxide analysis of breath sample ≥8 ppm
- •elevated affective distress
- •motivation to quit
- •computer proficient
排除标准
- •current use of other tobacco or nicotine products for recreation or to aid in cessation, use of pharmacological intervention for cessation, or current enrollment in a psychosocial intervention 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
- •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 a HRVB or confound autonomic parameters:
- •self-reported medical issues of potential concern to nicotine patch users
研究组 & 干预措施
Heart Rate Variability Biofeedback-Smoking Cessation Therapy
All participants in this open trial received individualized cognitive-behavioral smoking cessation treatment (SCT), up to 8 weeks of the transdermal nicotine patch (NRT) and individualized heart rate variability biofeedback (HRVB).
干预措施: Cognitive-Behavioral Smoking Cessation (Behavioral)
Heart Rate Variability Biofeedback-Smoking Cessation Therapy
All participants in this open trial received individualized cognitive-behavioral smoking cessation treatment (SCT), up to 8 weeks of the transdermal nicotine patch (NRT) and individualized heart rate variability biofeedback (HRVB).
干预措施: Heart Rate Variability Biofeedback (HRVB) (Behavioral)
Heart Rate Variability Biofeedback-Smoking Cessation Therapy
All participants in this open trial received individualized cognitive-behavioral smoking cessation treatment (SCT), up to 8 weeks of the transdermal nicotine patch (NRT) and individualized heart rate variability biofeedback (HRVB).
干预措施: Transdermal Nicotine patch (Drug)
结局指标
主要结局
Intervention Feasibility: Participant Attendance
时间窗: 7 weeks
Number of intervention sessions attended out of 10 possible sessions.
Intervention Feasibility: Participant Ratings of Effectiveness
时间窗: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
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. Higher scores on this scale are indicative of greater perceived intervention efficacy. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Intervention Feasibility: Participant Ratings of Appropriateness
时间窗: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
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. Higher scores on this scale are indicative of greater perceived intervention appropriateness. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Intervention Feasibility: Participant Ratings of Ease of the Intervention
时间窗: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
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. Higher scores on this scale are indicative of greater perceived ease of the intervention and fit into daily lifestyle. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Intervention Acceptability: Participant Ratings of Satisfaction and Liking
时间窗: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Satisfaction and liking were assessed via self-report ratings on five items assessing satisfaction with learning the intervention, liking the intervention, breathing techniques, nicotine replacement, and recommending the intervention to friends, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater intervention acceptability. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
次要结局
- Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)(Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up))
- Cigarettes Smoked Per Day(Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up))
- Change in Total Emotional Distress(Week 0 (i.e., baseline), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit) and Week 16 (i.e., 3-month follow-up))
研究者
Teresa M. Leyro, Ph.D.
Associate Professor
Rutgers, The State University of New Jersey