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OpenTrials
Completed

NCT Number: NCT03972137

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.

Completed

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rutgers, School of Arts and Sciences, One Spring Street

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Smoking Cessation

Behavioral

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)

Heart Rate Variability Biofeedback (HRVB)

Behavioral

All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.

Other names: Biofeedback, Respiratory biofeedback

Transdermal Nicotine Patch

Drug

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)

Primary outcomes

  1. Intervention Feasibility: Participant Attendance

    Time frame: 7 weeks

    Number of intervention sessions attended out of 10 possible sessions.

  2. Intervention Feasibility: Participant Ratings of Effectiveness

    Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

    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.

  3. Intervention Feasibility: Participant Ratings of Appropriateness

    Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

    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.

  4. Intervention Feasibility: Participant Ratings of Ease of the Intervention

    Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

    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.

  5. Intervention Acceptability: Participant Ratings of Satisfaction and Liking

    Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

    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.

Secondary outcomes

  1. Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)

    Time frame: Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)

    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).

  2. Cigarettes Smoked Per Day

    Time frame: Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)

    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).

  3. Change in Total Emotional Distress

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: HRVB-SCT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 3, 2019
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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