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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

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE June 3, 2019
Results First Submitted Date  ICMJE June 5, 2020
Results First Posted Date  ICMJE August 25, 2020
Last Update Posted Date August 25, 2020
Actual Study Start Date  ICMJE April 24, 2019
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2020)
  • Intervention Feasibility: Participant Attendance [ Time Frame: 7 weeks ]
    Number of intervention sessions attended out of 10 possible sessions.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Intervention Feasibility: Participant Attendance and Adherence [ Time Frame: Weekly from Week 1 through Week 7 ]
    A composite index of attendance and adherence (e.g., homework completion) will be used to index intervention feasibility, from Week 1 through Week 7 (i.e., end-of-treatment).
  • Intervention Feasibility, Treatment Initiation: Participant Ratings of Perceived Effectiveness and Appropriateness [ Time Frame: Week 1 ]
    Feasibility will be assessed via participant ratings of perceived effectiveness of the intervention in terms of helping them quit and manage emotional distress, ease of use, and perceived appropriateness of the intervention, upon treatment initiation.
  • Intervention Feasibility, End-of Treatment: Participant Ratings of Perceived Effectiveness and Appropriateness [ Time Frame: Week 7, i.e., end-of-treatment ]
    Feasibility will be assessed via participant ratings of perceived effectiveness of the intervention in terms of helping them quit and manage emotional distress, ease of use, and perceived appropriateness of the intervention, upon completing the intervention.
  • Intervention Acceptability, Treatment Initiation: Participant Ratings of Satisfaction and Liking [ Time Frame: Week 1 ]
    Acceptability of the intervention will be based on participant ratings of satisfaction and liking of intervention components, upon treatment initiation.
  • Intervention Acceptability, End-of-Treatment: Participant Ratings of Satisfaction and Liking [ Time Frame: Week 7, i.e., end-of-treatment ]
    Acceptability of the intervention will be based on participant ratings of satisfaction and liking of intervention components, upon completing the intervention at Week 7.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Changes in Smoking Rate [ Time Frame: Week 0 (i.e., baseline), Week 3 (i.e., quit date), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit), and Week 16 (i.e., 3-months post-quit) ]
    Change in smoking behavior from Week 0 (i.e., baseline) through Week 16 (i.e., 3-months post-quit) will be assessed via the well established Timeline Followback calendar interview.
  • Smoking Cessation [ Time Frame: Week 3 (i.e, Quit date), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit), and Week 16 (i.e., 3-months post-quit) ]
    Smoking cessation will be based upon self-report and carbon monoxide analysis of breath sample (<5 ppm) at Week 3, i.e., the quit date, and at Week 5, Week 7, and Week 16, corresponding with 2-weeks, 1-month, and 3-months post-quit date. Participants whose abstinence is verified via carbon monoxide analysis of breath at Week 16, which occurs approximately five weeks following transdermal nicotine patch termination for those who use the full 8-week course, will provide a saliva sample for cotinine testing to biologically verify abstinence (<12 ng/mL). Participants whose carbon monoxide analysis of breath sample (I.e., Weeks 3, 5, and 7) or cotinine analysis (Week 16) do not indicate abstinence will be coded as smoking.
  • Change in Total Emotional Distress [ Time Frame: Week 0, Week 5, Week 7, Week 16, i.e., baseline, 2-weeks, 1-month, and 3-months post-quit ]
    Self-reported changes, over time, in total emotional distress will be evaluated via the 21-item, Depression, Anxiety and Stress Scale from Week 0 (i.e., baseline) to Week 5 Week 7, and Week 16, corresponding with 2-weeks, 1-month, and 3-months post-quit. Items will be 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Rate Variability Biofeedback for Smoking Cessation
Official Title  ICMJE Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Tobacco Smoking
Intervention  ICMJE
  • 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)
Study Arms  ICMJE 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).
Interventions:
  • Behavioral: Cognitive-Behavioral Smoking Cessation
  • Behavioral: Heart Rate Variability Biofeedback (HRVB)
  • Drug: Transdermal Nicotine patch
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 20, 2020
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972137
Other Study ID Numbers  ICMJE 2018001848
R34DA043751 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Teresa M. Leyro, Ph.D., Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Teresa Leyro, Ph.D. Rutgers, The State University of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP