Trial Outcomes & Findings for Heart Rate Variability Biofeedback for Smoking Cessation (NCT NCT03972137)

NCT ID: NCT03972137

Last Updated: 2020-08-25

Results Overview

Number of intervention sessions attended out of 10 possible sessions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 7 weeks
• Results posted on: 2020-08-25

Participant Flow

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.

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.

Participant milestones

Measure	Heart Rate Variability Biofeedback- Smoking Cessation Therapy 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.
Overall Study STARTED	10
Overall Study Enrolled	10
Overall Study Treatment Completed	6
Overall Study Follow-up Completed	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Heart Rate Variability Biofeedback- Smoking Cessation Therapy 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.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Heart Rate Variability Biofeedback for Smoking Cessation

Baseline characteristics by cohort

Measure	Enrolled n=10 Participants Participants who were eligible and completed the Baseline session
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36.3 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 weeks

Population: 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.

Number of intervention sessions attended out of 10 possible sessions.

Outcome measures

Measure	Intent-to-treat (ITT) n=10 Participants Participants who completed their baseline session and were enrolled in the study	Remained in Treatment Beyond One Session n=7 Participants Excluding n=3 participants who withdrew following one intervention session.	3-month Follow-up (3MFU) 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.	3-month Follow-up (3MFU) Participants who attended their 3-month follow-up session
Intervention Feasibility: Participant Attendance	6.30 Sessions Standard Deviation 4.08	8.71 Sessions Standard Deviation 1.49	—	—

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Intent-to-treat (ITT) n=9 Participants Participants who completed their baseline session and were enrolled in the study	Remained in Treatment Beyond One Session n=4 Participants Excluding n=3 participants who withdrew following one intervention session.	3-month Follow-up (3MFU) 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.	3-month Follow-up (3MFU) Participants who attended their 3-month follow-up session
Intervention Feasibility: Participant Ratings of Effectiveness	3.03 score on a scale Standard Deviation 0.83	3.19 score on a scale Standard Deviation 0.52	—	—

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Intent-to-treat (ITT) n=9 Participants Participants who completed their baseline session and were enrolled in the study	Remained in Treatment Beyond One Session n=4 Participants Excluding n=3 participants who withdrew following one intervention session.	3-month Follow-up (3MFU) 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.	3-month Follow-up (3MFU) Participants who attended their 3-month follow-up session
Intervention Feasibility: Participant Ratings of Appropriateness	3.61 score on a scale Standard Deviation 0.69	2.87 score on a scale Standard Deviation 0.75	—	—

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Intent-to-treat (ITT) n=9 Participants Participants who completed their baseline session and were enrolled in the study	Remained in Treatment Beyond One Session n=4 Participants Excluding n=3 participants who withdrew following one intervention session.	3-month Follow-up (3MFU) 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.	3-month Follow-up (3MFU) Participants who attended their 3-month follow-up session
Intervention Feasibility: Participant Ratings of Ease of the Intervention	2.4 score on a scale Standard Deviation 0.84	1.58 score on a scale Standard Deviation 0.32	—	—

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Intent-to-treat (ITT) n=9 Participants Participants who completed their baseline session and were enrolled in the study	Remained in Treatment Beyond One Session n=3 Participants Excluding n=3 participants who withdrew following one intervention session.	3-month Follow-up (3MFU) 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.	3-month Follow-up (3MFU) Participants who attended their 3-month follow-up session
Intervention Acceptability: Participant Ratings of Satisfaction and Liking	3.24 score on a scale Standard Deviation 0.71	3.52 score on a scale Standard Deviation 0.31	—	—

SECONDARY outcome

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

Population: 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.

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).

Outcome measures

Measure	Intent-to-treat (ITT) n=7 Participants Participants who completed their baseline session and were enrolled in the study	Remained in Treatment Beyond One Session n=4 Participants Excluding n=3 participants who withdrew following one intervention session.	3-month Follow-up (3MFU) 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.	3-month Follow-up (3MFU) Participants who attended their 3-month follow-up session
Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm) Cotinine verified abstinence	NA participants Salivary cotinine was only collected at 3-month follow-up	4 participants	—	—
Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm) Self-Reported abstinence	6 participants	4 participants	—	—
Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm) CO <8 parts per million (PPM)	2 participants	4 participants	—	—

SECONDARY outcome

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

Population: 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

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).

Outcome measures

Measure	Intent-to-treat (ITT) n=10 Participants Participants who completed their baseline session and were enrolled in the study	Remained in Treatment Beyond One Session n=7 Participants Excluding n=3 participants who withdrew following one intervention session.	3-month Follow-up (3MFU) n=4 Participants 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.	3-month Follow-up (3MFU) Participants who attended their 3-month follow-up session
Cigarettes Smoked Per Day	11.56 Cigarettes smoked per day (CPD) Standard Deviation 6.03	0.14 Cigarettes smoked per day (CPD) Standard Deviation 0.38	0 Cigarettes smoked per day (CPD) Standard Deviation 0	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	Intent-to-treat (ITT) n=10 Participants Participants who completed their baseline session and were enrolled in the study	Remained in Treatment Beyond One Session n=6 Participants Excluding n=3 participants who withdrew following one intervention session.	3-month Follow-up (3MFU) n=5 Participants 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.	3-month Follow-up (3MFU) n=4 Participants Participants who attended their 3-month follow-up session
Change in Total Emotional Distress DASS-21 Total score	39.9 score on a scale Standard Deviation 14.0	23.5 score on a scale Standard Deviation 12.85	12.2 score on a scale Standard Deviation 3.11	13.75 score on a scale Standard Deviation 6.55
Change in Total Emotional Distress DASS-21 Depression score	11.5 score on a scale Standard Deviation 4.74	5.0 score on a scale Standard Deviation 2.76	3.0 score on a scale Standard Deviation 2.23	4.0 score on a scale Standard Deviation 2.71
Change in Total Emotional Distress DASS-21 Anxiety score	11.7 score on a scale Standard Deviation 4.39	5.3 score on a scale Standard Deviation 1.75	2.8 score on a scale Standard Deviation 1.64	3.5 score on a scale Standard Deviation 1.29
Change in Total Emotional Distress DASS-21 Stress score	16.7 score on a scale Standard Deviation 6.03	13.17 score on a scale Standard Deviation 10.07	6.4 score on a scale Standard Deviation 2.07	6.25 score on a scale Standard Deviation 2.98

Adverse Events

Enrolled

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Teresa Leyro

Rutgers, The State University of New Jersey

Phone: 848-445-2090

Email: tml124@psych.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place