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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03972137
Recruitment Status : Completed
First Posted : June 3, 2019
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Teresa M. Leyro, Ph.D., Rutgers, The State University of New Jersey

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Smoking Behavioral: Cognitive-Behavioral Smoking Cessation Behavioral: Heart Rate Variability Biofeedback (HRVB) Drug: Transdermal Nicotine patch Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants received individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB).
Masking: None (Open Label)
Masking Description: This is an open trial with all participants receiving what will become the 'active intervention' in a subsequent randomized clinical trial.
Primary Purpose: Treatment
Official Title: Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation
Actual Study Start Date : April 24, 2019
Actual Primary Completion Date : February 20, 2020
Actual Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972137


Locations
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United States, New Jersey
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
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Principal Investigator: Teresa Leyro, Ph.D. Rutgers, The State University of New Jersey
  Study Documents (Full-Text)

Documents provided by Teresa M. Leyro, Ph.D., Rutgers, The State University of New Jersey:
Informed Consent Form  [PDF] October 3, 2018

Publications:
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Responsible Party: Teresa M. Leyro, Ph.D., Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03972137    
Other Study ID Numbers: 2018001848
R34DA043751 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2019    Key Record Dates
Results First Posted: August 25, 2020
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teresa M. Leyro, Ph.D., Rutgers, The State University of New Jersey:
Smoking Cessation
Heart rate variability biofeedback
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action