Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Study Overview
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Brief Summary
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The purpose of the study is to conduct an open trial examining the feasibility and acceptability of a refined heart rate variability biofeedback and smoking cessation treatment using a hybrid model wherein individuals receive the majority of the intervention virtually.

Detailed Description
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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 assist in further refining the intervention for a larger R01 RCT.

Official Title
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Open Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Smoking Cessation
* Biological: Heart Rate Variability Biofeedback
* Drug: Nicotine patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)<br>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). | Behavioral: Cognitive-Behavioral Smoking Cessation<br>* Participants will be provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.<br>* Other names: Smoking cessation counseling;Biological: Heart Rate Variability Biofeedback<br>* Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.<br>* Other names: Respiratory biofeedback;Drug: Nicotine patch<br>* All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.<br>* Other names: Nicotine replacement therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Feasibility: Participant Attendance | Number of intervention sessions attended out of 7 possible sessions | 7 weeks | 
| Intervention Feasibility: Participant Practice Adherence | Time (in minutes) spent practicing the breathing intervention | 7 weeks | 
| Intervention Feasibility: Participant Ratings of Effectiveness | Effectiveness will be 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. | Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-MFU) | 
| Intervention Feasibility: Participant Ratings of Appropriateness | Appropriateness will be 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. | Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-MFU) | 
| Intervention Feasibility: Participant Ratings of Ease of the Intervention | Ease of the Intervention will be 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. | Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-MFU) | 
| Intervention Feasibility: Interventionist Ratings of Technological Limitations | Technological limitations will be 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. | 7 weeks | 
| Intervention Acceptability: Participant Rating of Satisfaction and Liking | 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. Higher scores on this scale are indicative of greater satisfaction and liking of the intervention and greater perceived intervention acceptability. | Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-MFU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in emotional distress | Changes in emotional distress over the course of the intervention will be assessed via participant self-reported responses on the Depression, Anxiety, and Stress Scale-21 (DASS-21). The DASS-21 is composed of three self-report scales that measure 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). An outcome score for each depression, anxiety and stress scale (7-items each) is calculated by summing the scores for the relevant scale items (range of possible scores for each scale at each time point is 0-21, with higher scores indicating greater emotional distress or a worse outcome). | Week 0, Week 5, Week 7, and Week 16 (i.e., Baseline, 2-WFU, 1-MFU, 3-MFU) | 
| Changes in smoking behavior: Quit Day Abstinence | Quit day abstinence will be assessed via self-reported smoking abstinence on Quit Day and verified via carbon monoxide (CO) analysis of breath sample (CO < 8ppm). | Week 3 (i.e., Quit Date) | 
| Changes in smoking behavior: Sustained Smoking Cessation | Sustained smoking cessation will be 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). | Week 16 (i.e., 3-MFU) | 
| Changes in smoking behavior: Reduced Smoking Rate | Reductions in smoking rate will be assessed via self-report responses on the Timeline Followback interview. | Week 0, Week 3, Week 5, Week 7, and Week 16 (i.e., Baseline, Quit Date, 2-WFU, 1-MFU, 3-MFU) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Heart Rate Variability Biofeedback