Heart Rate Variability Biofeedback for Smoking Cessation

Tobacco Smoking Clinical Trial

— HRVB-SCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972137
• Other study ID #: 2018001848
• Secondary ID: R34DA043751
• Status: Completed
• Phase: Phase 2
• Start date: April 24, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: August 2020
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

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.
• Heart Rate Variability Biofeedback (HRVB)
All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.

Drug:
• Transdermal Nicotine patch
All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.

Locations

Country	Name	City	State
United States	Rutgers, School of Arts and Sciences, One Spring Street	New Brunswick	New Jersey

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Feasibility: Participant Attendance	Number of intervention sessions attended out of 10 possible sessions.	7 weeks
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)