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

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tobacco Smoking
Interventions Behavioral: Cognitive-Behavioral Smoking Cessation
Behavioral: Heart Rate Variability Biofeedback (HRVB)
Drug: Transdermal Nicotine patch
Enrollment 10
Recruitment Details Participants were recruited from the New Brunswick, New Jersey area via flyer postings, clinic referrals, and social media advertisements. The first participant was enrolled April 24, 2019 and the last participant was enrolled November 12, 2019.
Pre-assignment Details The intervention occurred across 10 sessions. All participants received individualized heart rate variability biofeedback at each session, smoking cessation therapy during 6 of the sessions and 8 weeks of transdermal nicotine patches. Two of the twelve consented participants who attended the baseline visit were not eligible and were not enrolled.
Arm/Group Title Heart Rate Variability Biofeedback- Smoking Cessation Therapy
Hide Arm/Group Description

All participants in this open trial received individualized cognitive-behavioral smoking cessation treatment, up to 8 weeks of the transdermal nicotine patch, and individualized heart rate variability biofeedback.

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

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

Period Title: Overall Study
Started 10
Enrolled 10
Treatment Completed 6
Follow-up Completed 4
Completed 4
Not Completed 6
Reason Not Completed
Lost to Follow-up             2
Withdrawal by Subject             4
Arm/Group Title Enrolled
Hide Arm/Group Description Participants who were eligible and completed the Baseline session
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
36.3  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
7
  70.0%
Male
3
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
  80.0%
Unknown or Not Reported
2
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
  10.0%
Black or African American
3
  30.0%
White
4
  40.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Intervention Feasibility: Participant Attendance
Hide Description Number of intervention sessions attended out of 10 possible sessions.
Time Frame 7 weeks
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Hide Analysis Population Description
Data on both the Intent-to-treat (ITT) N=10 participants who completed the baseline session and were enrolled in the study and the n=7 who received more than one Heart Rate Variability Biofeedback Session (HRVB) and one Smoking Cessation Treatment (SCT) session (i.e. which occurred during their first intervention appointment) are reported.
Arm/Group Title Intent-to-treat (ITT) Remained in Treatment Beyond One Session
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Participants who completed their baseline session and were enrolled in the study
Excluding n=3 participants who withdrew following one intervention session.
Overall Number of Participants Analyzed 10 7
Mean (Standard Deviation)
Unit of Measure: Sessions
6.30  (4.08) 8.71  (1.49)
2.Primary Outcome
Title Intervention Feasibility: Participant Ratings of Effectiveness
Hide Description 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.
Time Frame Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the N=10 participants who were enrolled in the study, n=9 completed this measure following their baseline appointment; n=4 attended their 3-month follow-up.
Arm/Group Title First Session 3-month Follow-up (3MFU)
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Participants who attended their first intervention session
Participants who attended their 3-month follow-up session
Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.03  (0.83) 3.19  (0.52)
3.Primary Outcome
Title Intervention Feasibility: Participant Ratings of Appropriateness
Hide Description 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.
Time Frame Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the N=10 participants who were enrolled in the study, n=9 completed this measure following their baseline appointment; n=4 attended their 3-month follow-up.
Arm/Group Title First Session 3-month Follow-up (3MFU)
Hide Arm/Group Description:
Participants who attended their first intervention session
Participants who attended their 3-month follow-up session
Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.61  (0.69) 2.87  (0.75)
4.Primary Outcome
Title Intervention Feasibility: Participant Ratings of Ease of the Intervention
Hide Description 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.
Time Frame Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the N=10 participants who were enrolled in the study, n=9 completed this measure following their baseline appointment; n=4 attended their 3-month follow-up.
Arm/Group Title First Session 3-month Follow-up (3MFU)
Hide Arm/Group Description:
Participants who attended their first intervention session
Participants that attended their 3-month follow-up session
Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.4  (0.84) 1.58  (0.32)
5.Primary Outcome
Title Intervention Acceptability: Participant Ratings of Satisfaction and Liking
Hide Description 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.
Time Frame Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the N=10 participants who were enrolled in the study, n=9 completed this measure following their baseline appointment; n=3 attended their 3-month follow-up and provided complete data for this measure.
Arm/Group Title First Session 3-month Follow-up (3MFU)
Hide Arm/Group Description:
Participants who attended their first intervention session
Participants who attended their 3-month follow-up session
Overall Number of Participants Analyzed 9 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.24  (0.71) 3.52  (0.31)
6.Secondary Outcome
Title Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)
Hide Description

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).

Time Frame Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the N=9 who were eligible and initiated treatment, n=7 attended their quit date and n=4 attended their 3-month follow-up.
Arm/Group Title Quit Date 3-month Follow-up (3MFU)
Hide Arm/Group Description:
Participants who attended their Quit day session
Participants who attended their 3-month follow-up session
Overall Number of Participants Analyzed 7 4
Measure Type: Number
Unit of Measure: participants
Self-Reported abstinence 6 4
Cotinine verified abstinence NA [1]  4
CO <8 parts per million (PPM) 2 4
[1]
Salivary cotinine was only collected at 3-month follow-up
7.Secondary Outcome
Title Cigarettes Smoked Per Day
Hide Description 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).
Time Frame Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the N=10 participants who were eligible and attended the baseline session, n=7 attended their quit date and n=4 attended their 3-month follow-up session
Arm/Group Title Baseline (BL) Quit Date 3-month Follow-up (3MFU)
Hide Arm/Group Description:
Mean CPD at baseline was determined by averaging the total number of cigarettes smoked per day for 30 the days prior to the participant's baseline session. Data reflect participants who attended their baseline session.
Mean CPD at Quit date was determined by averaging the total number of cigarettes smoked on their Quit-day session. Data reflect participants who attended their Quit-day session.
Mean CPD at 3-Month Follow-up was determined by averaging the total number of cigarettes smoked during the 7 days prior to their 3MFU session. Data reflect participants who attended their 3MFU session.
Overall Number of Participants Analyzed 10 7 4
Mean (Standard Deviation)
Unit of Measure: Cigarettes smoked per day (CPD)
11.56  (6.03) 0.14  (0.38) 0  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline (BL), Quit Date
Comments [Not Specified]
Type of Statistical Test Other
Comments A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline (BL) to Quit Day.
Statistical Test of Hypothesis P-Value .003
Comments The threshold for statistical significance was p < 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.42
Confidence Interval (2-Sided) 95%
5.79 to 17.05
Parameter Dispersion
Type: Standard Deviation
Value: 6.08
Estimation Comments Mean difference represents the difference of mean cigarettes smoked per day at Baseline and Quit Date (Mean CPD at Baseline - Mean CPD at Quit Date).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baseline (BL), 3-month Follow-up (3MFU)
Comments [Not Specified]
Type of Statistical Test Other
Comments A paired-samples t-test was used to evaluate smoking reduction in participants from baseline (BL) to 3-month follow-up session (3MFU).
Statistical Test of Hypothesis P-Value .067
Comments The threshold for statistical significance was p < 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
-1.55 to 25.35
Parameter Dispersion
Type: Standard Deviation
Value: 8.45
Estimation Comments Mean difference represents the difference of mean cigarettes smoked per day at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.
8.Secondary Outcome
Title Change in Total Emotional Distress
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the N=10 participants who were eligible and attended their baseline session, n=6 attended their 2-weeks post-quit session, n=5 attended their 1-month post-quit session, n=4 attended 3-month follow-up session.
Arm/Group Title Baseline (BL) 2-weeks Post-quit (2W) 1-month Post-quit (1M) 3-month Follow-up (3MFU)
Hide Arm/Group Description:
Participants who attended their baseline session
Participants who attended their 2-weeks post-quit session
Participants who attended their 1-month post-quit session
Participants who attended their 3-month follow-up session
Overall Number of Participants Analyzed 10 6 5 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
DASS-21 Total score 39.9  (14.0) 23.5  (12.85) 12.2  (3.11) 13.75  (6.55)
DASS-21 Depression score 11.5  (4.74) 5.0  (2.76) 3.0  (2.23) 4.0  (2.71)
DASS-21 Anxiety score 11.7  (4.39) 5.3  (1.75) 2.8  (1.64) 3.5  (1.29)
DASS-21 Stress score 16.7  (6.03) 13.17  (10.07) 6.4  (2.07) 6.25  (2.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline (BL), 2-weeks Post-quit (2W)
Comments [Not Specified]
Type of Statistical Test Other
Comments A paired-samples t-test was conducted to examine the difference in the DASS-21 total score from baseline (BL) to 2-weeks post-quit (2W).
Statistical Test of Hypothesis P-Value .010
Comments The threshold for statistical significance was p < 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19.67
Confidence Interval (2-Sided) 95%
7.17 to 32.17
Parameter Dispersion
Type: Standard Deviation
Value: 11.91
Estimation Comments Mean difference represents the difference of mean DASS-21 total scores at Baseline and 2-weeks post-quit. Estimated value reported is reflective of the n=6 participants that attended the 2-weeks post quit session.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baseline (BL), 1-month Post-quit (1M)
Comments [Not Specified]
Type of Statistical Test Other
Comments A paired-samples t-test was conducted to examine the difference in DASS-21 Total scores from baseline (BL) to 1-month post-quit (1M).
Statistical Test of Hypothesis P-Value .027
Comments The threshold for statistical significance was p < 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 31.2
Confidence Interval (2-Sided) 95%
5.88 to 56.52
Parameter Dispersion
Type: Standard Deviation
Value: 20.4
Estimation Comments Mean difference represents the difference of mean DASS-21 total scores at Baseline and 1-month post-quit. Estimated value reported is reflective of the n=5 participants that attended the 1-month post-quit session.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baseline (BL), 3-month Follow-up (3MFU)
Comments [Not Specified]
Type of Statistical Test Other
Comments A paired-samples t-test was conducted to evaluate the difference in DASS-21 total scores from baseline (BL) to 3-month follow up (3MFU).
Statistical Test of Hypothesis P-Value .045
Comments The threshold for statistical significance was p < 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.75
Confidence Interval (2-Sided) 95%
1.09 to 50.41
Parameter Dispersion
Type: Standard Deviation
Value: 15.5
Estimation Comments Mean difference represents the difference of mean DASS-21 total scores at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.
Time Frame Baseline (i.e. Week 0), End of Treatment (i.e. Week 7, 1-month post-quit), 3-month follow-up (i.e. Week 16)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enrolled
Hide Arm/Group Description Participants who were eligible and completed the baseline session
All-Cause Mortality
Enrolled
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide Serious Adverse Events
Enrolled
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enrolled
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Teresa Leyro
Organization: Rutgers, The State University of New Jersey
Phone: 848-445-2090
EMail: tml124@psych.rutgers.edu
Layout table for additonal information
Responsible Party: Teresa M. Leyro, Ph.D., Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03972137    
Other Study ID Numbers: 2018001848
R34DA043751 ( U.S. NIH Grant/Contract )
First Submitted: May 20, 2019
First Posted: June 3, 2019
Results First Submitted: June 5, 2020
Results First Posted: August 25, 2020
Last Update Posted: August 25, 2020