Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2023-06-15

Brief Summary

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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.

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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 inform a subsequent randomized clinical trial.

Conditions

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Tobacco Smoking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open trial with all participants receiving the experimental intervention (HRVB) in addition to smoking cessation therapy and nicotine replacement therapy patch.

Study Groups

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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).

Group Type EXPERIMENTAL

Cognitive-Behavioral Smoking Cessation

Intervention Type BEHAVIORAL

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.

Heart Rate Variability Biofeedback

Intervention Type BIOLOGICAL

Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.

Nicotine patch

Intervention Type DRUG

All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.

Interventions

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Cognitive-Behavioral Smoking Cessation

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.

Intervention Type BEHAVIORAL

Heart Rate Variability Biofeedback

Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.

Intervention Type BIOLOGICAL

Nicotine patch

All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.

Intervention Type DRUG

Other Intervention Names

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Cognitive-behavioral therapy Smoking cessation counseling Biofeedback Respiratory biofeedback Transdermal nicotine patch Nicotine replacement therapy

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes