Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Phase 2

Completed

Conditions: Tobacco Smoking

Interventions: Behavioral: Cognitive-Behavioral Smoking Cessation
Biological: Heart Rate Variability Biofeedback
Drug: Nicotine patch

Registration Number: NCT05224050

Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility: Participant Attendance	6 weeks	Number of intervention sessions attended out of 7 possible sessions.
Intervention Feasibility: Participant Practice Adherence	6 weeks	Time (in minutes) spent practicing the breathing intervention
Intervention Feasibility: Participant Ratings of Effectiveness	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
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)	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. Anxiety: Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, Extremely Severe: 10-21. Stress: Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, Extremely Severe: 17-21. 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.
Changes in Smoking Behavior: Quit Day Abstinence	Week 3 (i.e., Quit Date)	Quit day abstinence was assessed via self-reported smoking abstinence on Quit Day and verified via carbon monoxide (CO) analysis of breath sample (CO \< 8ppm).
Changes in Smoking Behavior: Sustained Smoking Cessation	Week 16 (i.e., 3-MFU)	Sustained smoking cessation was assessed via self-reported abstinence at 3-months post-quit) and verified via carbon monoxide (CO) analysis (CO \< 8ppm) and salivary cotinine levels (\<10 ng/mL).
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)	Cigarettes smoked per day (CPD) assessed via self-report responses on the Timeline Followback interview were used to measure changes in smoking behavior from Baseline through Quit Date, 2-weeks post-quit, 1-month post-quit, and 3-months follow up.