Heart Rate Variability Biofeedback for Smoking Cessation (HRVB-SCT)

Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Smoking Cessation; Behavioral: Heart Rate Variability Biofeedback (HRVB); Drug: Transdermal Nicotine patch

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers, School of Arts and Sciences, One Spring Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Heart Rate Variability Biofeedback-Smoking Cessation Therapy; 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).

Behavioral: Cognitive-Behavioral Smoking Cessation; Participants were 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 (SCT); Behavioral: Heart Rate Variability Biofeedback (HRVB); All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.; Other Names: Biofeedback; Respiratory biofeedback; Drug: Transdermal Nicotine patch; All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.; Other Names: Nicotine patch; Nicotine replacement therapy (NRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility: Participant Attendance	Number of intervention sessions attended out of 10 possible sessions.	7 weeks
Intervention Feasibility: Participant Ratings of Effectiveness	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.	Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Intervention Feasibility: Participant Ratings of Appropriateness	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.	Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Intervention Feasibility: Participant Ratings of Ease of the Intervention	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.	Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Intervention Acceptability: Participant Ratings of Satisfaction and Liking	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.	Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)	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).	Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
Cigarettes Smoked Per Day	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).	Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
Change in Total Emotional Distress	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.	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)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Teresa Leyro, Ph.D., Rutgers, The State University of New Jersey

Publications and helpful links

General Publications

• Leyro TM, Buckman JF, Bates ME. Theoretical implications and clinical support for heart rate variability biofeedback for substance use disorders. Curr Opin Psychol. 2019 Dec;30:92-97. doi: 10.1016/j.copsyc.2019.03.008. Epub 2019 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Smoking Cessation; Heart rate variability biofeedback
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2018001848; R34DA043751 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We currently have no plans to share individual participant data from this small open trial as it will be used to guide refinement of a subsequent larger randomized controlled trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No