Heart Rate Variability Biofeedback for Smoking Cessation

Phase 2

Completed

Conditions: Tobacco Smoking

Interventions: Behavioral: Cognitive-Behavioral Smoking Cessation
Behavioral: Heart Rate Variability Biofeedback (HRVB)
Drug: Transdermal Nicotine patch

Registration Number: NCT03972137

Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heart Rate Variability Biofeedback-Smoking Cessation Therapy	Cognitive-Behavioral Smoking Cessation	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).
Heart Rate Variability Biofeedback-Smoking Cessation Therapy	Heart Rate Variability Biofeedback (HRVB)	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).
Heart Rate Variability Biofeedback-Smoking Cessation Therapy	Transdermal Nicotine patch	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).

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility: Participant Attendance	7 weeks	Number of intervention sessions attended out of 10 possible sessions.
Intervention Feasibility: Participant Ratings of Effectiveness	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
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)	Quit status was assessed on Quit day via self-reported abstinence and carbon monoxide analysis of breath sample (CO \<8 ppm). Given carbon monoxide analysis of breath may not be a valid indicator of cessation within the first 24 hours, we suggest interpretation of this outcome on Quit day with caution. Sustained smoking cessation was evaluated at study termination (i.e., 3-month follow-up) via self-reported abstinence, carbon monoxide analysis ( CO \<8 ppm), and salivary cotinine (\<10 ng/mL).
Cigarettes Smoked Per Day	Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)	Cigarettes Smoked Per Day (CPD) assessed via the well established Timeline Followback calendar interview were used to measure changes in smoking behavior from Week 0 (i.e., Baseline) through 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)	Self-reported change in emotional distress was evaluated via the 21-item, Depression, Anxiety and Stress Scale (DASS-21). The DASS-21 is composed of three self-report scales that measure the emotional states of depression, anxiety and stress. Items are rated on a Likert-type scale (0=Did not apply to me at all, to 3=Applied to me very much, or most of the time). Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. The severity ratings are as follows Depression: Normal 0-4, Mild: 5-6, Moderate: 7-10, Severe: 11-13, Extremely Severe: 14-21. Stress: Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, Extremely Severe: 17-21. Anxiety: Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, Extremely Severe: 10-21. Total scores are computed by summing the subscales. Total scores for the DASS-21 range from 0-63. For all scales, higher scores are indicative of greater emotional distress and less change in total distress symptoms over time.