HRVB-SCT-RCT: Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Recruiting
CT.gov ID
NCT05224050
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
60
1
2
20
3

Study Details

Study Description

Brief Summary

The purpose of the study is to conduct a pilot randomized controlled trial to examine the efficacy of heart rate variability biofeedback versus breath awareness training as a smoking cessation treatment adjunct for smokers with moderate emotional distress.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive-Behavioral Smoking Cessation
  • Biological: Heart Rate Variability Biofeedback
  • Drug: Nicotine patch
  • Biological: Breathing Awareness Training
Phase 2

Detailed Description

The present investigation is a pilot randomized controlled trial (RCT) of investigating heart rate variability biofeedback (HRVB) smoking cessation treatment for smokers with moderate levels of emotional distress. Significant findings will 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) compare the efficacy of HRVB versus a time-matched, control (e.g., Breath Awareness Training), as smoking cessation adjunct and assess transdiagnostic mechanisms of interest and (b) collect additional information to assist in further refining the intervention for a larger R01 RCT.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment
Actual Study Start Date :
Nov 29, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Heart Rate Variability Biofeedback (HRVB)

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

Behavioral: 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.
Other Names:
  • Cognitive-behavioral therapy
  • Smoking cessation counseling
  • Biological: Heart Rate Variability Biofeedback
    Participants will be provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.
    Other Names:
  • Biofeedback
  • Respiratory biofeedback
  • Drug: Nicotine patch
    All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
    Other Names:
  • Transdermal nicotine patch
  • Nicotine replacement therapy
  • Sham Comparator: Breathing awareness training (BAT)

    The sham condition will consist of the exact same treatment; however, instead of engaging in resonance breathing, participants will be asked to follow a pacer, which will be set at pace of a 9-17 breaths per minute, consistent with typical breathing.

    Behavioral: 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.
    Other Names:
  • Cognitive-behavioral therapy
  • Smoking cessation counseling
  • Drug: Nicotine patch
    All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
    Other Names:
  • Transdermal nicotine patch
  • Nicotine replacement therapy
  • Biological: Breathing Awareness Training
    Participants will be asked to follow a breathing pacer, which will be set at pace of 9-17 breaths per minute, consistent with typical breathing.

    Outcome Measures

    Primary Outcome Measures

    1. Point Prevalence Abstinence as determined by self-report, carbon monoxide (CO) analysis of breath sample, and cotinine assay. [Measured at 3-month follow up]

      To compare the efficacy of Heart Rate Variability Biofeedback versus Breath Awareness Training in terms of cotinine verified point prevalence smoking abstinence at 3-months post cessation.

    Secondary Outcome Measures

    1. Nicotine withdrawal ratings as indexed by the Minnesota Nicotine Withdrawal Scale (MNWS) [Week 0, Week 2, Week 4, Week 6, Week 15 (i.e.baseline, quit week, 2 weeks, 1 month, 3 months post-quit)]

      To examine whether smokers assigned to Heart Rate Variability Biofeedback versus Breath Awareness Training evidence greater improvements in continuous smoking outcomes as indexed by self-reported nicotine withdrawal on the MNWS. The MNWS is a 15-item questionnaire, where each item is rated on a Likert scale ranging from 0=Not at all to 4=Severe. An outcome MNWS score for each time point is calculated as the sum of all items (range of possible scores for MNWS at each timepoint is 0-60, with higher MNWS scores at each timepoint indicating more withdrawal symptoms or a worse outcome).

    2. Smoking urges as indexed by the Brief Questionnaire of Smoking Urges (QSU-B) [Week 0, Week 2, Week 4, Week 6, Week 15 (i.e.baseline, quit week, 2 weeks, 1 month, 3 months post-quit)]

      To examine whether smokers assigned to Heart Rate Variability Biofeedback versus Breath Awareness Training evidence greater improvements in continuous smoking outcomes as indexed by self-reported smoking urges on the QSU-B. The QSU-B is a 10-item questionnaire, where each item is rated on a scale ranging from 0=Strongly Disagree to 100=Strongly Agree. An outcome QSU-B score for each time point is calculated as the sum of all items (range of possible scores for QSU-B at each time point is 0-1000, with higher QSU-B scores at each time point indicating greater smoking urges or a worse outcome).

    3. Emotional distress as indexed by the Depression, Anxiety, and Stress Scale-21 (DASS-21) [Week 0, Week 2, Week 4, Week 6, Week 15 (i.e.baseline, quit week, 2 weeks, 1 month, 3 months post-quit)]

      To examine whether smokers assigned to Heart Rate Variability Biofeedback versus Breath Awareness Training evidence greater improvements in emotional distress as indexed by self-reported anxiety, mood, and stress ratings on the DASS-21. The DASS-21 is composed of three self-report scales that measures 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). 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).

    Other Outcome Measures

    1. Vagal Functioning as indexed by High Frequency Heart Rate Variability Data [Week 0, Week 6, Week 15]

      To identify candidate treatment mechanisms by examining whether changes in cardiac vagal control account for treatment effects. Cardiac vagal control will be indexed as heart rate variability data in the high frequency range (HF-HRV). HF-HRV data will be collected continuously in 5-minute epochs at rest and in response to a task that requires attentional and cognitive demand using BIOPAC psychophysiological assessment equipment. For the current study, we will specifically assess changes in HF-HRV that correspond with respiratory sinus arrythmia, defined as the natural log of the variance occurring between 0.12 and 0.40 Hz. To specifically examine cardiac vagal control as a mechanism, we will examine whether changes in HF-HRV over time (i.e., Week 0, Week 6, Week 15) account for any treatment effects, where greater values (i.e., greater change) indicate improved cardiac vagal modulation of heart rate over time.

    2. Distress Tolerance as indexed by the Distress Tolerance Scale (DTS) [Week 0, Week 6, Week 15]

      To clarify candidate treatment mechanisms by examining whether changes in the perceived ability to tolerate distress accounts for the effects of heart rate variability biofeedback. Distress tolerance will be indexed via the DTS a 15-item self-report questionnaire. The DTS has four subscales: Tolerance, Absorption, Appraisal, and Regulation. Items for each subscale are ranked on a Likert-type scale ranging from 1=Strongly Agree to 5=Strongly Disagree. An outcome DTS score for each time point is calculated by averaging the items on each subscale and then averaging the four subscale scores (range of possible scores for the DTS at each time point is 1-5, with lower scores indicative of less distress tolerance or worse outcome).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 21-50

    • Smoking ≥ 5 cigarettes, daily, for at least two years

    • Expired carbon monoxide analysis of breath sample ≥8 ppm

    • DASS scores ≥ 14 on depression and/or ≥ 10 on anxiety and/or ≥ 19 on stress

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rutgers, School of Arts and Sciences, One Spring Street New Brunswick New Jersey United States 08901

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Teresa M, Leyro, Ph.D., Rutgers, The State University of New Jersey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Teresa M. Leyro, Ph.D., Principal Investigator, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT05224050
    Other Study ID Numbers:
    • Pro2019001539
    • 5R34DA043751-03
    First Posted:
    Feb 4, 2022
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 9, 2022