Trial Outcomes & Findings for Heart Rate Variability Biofeedback for Smoking Cessation Treatment (NCT NCT05224050)

NCT ID: NCT05224050

Last Updated: 2024-05-01

Results Overview

Number of intervention sessions attended out of 7 possible sessions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-05-01

Participant Flow

Participants were recruited from the greater Rutgers, New Brunswick community via posters, leaflets, mailings, online advertisements, community outreach (i.e., meetings with local organizations and treatment providers), and listservs. The first participant was enrolled 11/29/2021 and the last participant was enrolled 03/15/2023.

The intervention involved 7 sessions (2 in-person and 5 virtual remote) scheduled over a 6-week period. 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.

Participant milestones

Measure	Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT) All participants in this open trial received individualized heart rate variability biofeedback training (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT). Heart Rate Variability Biofeedback: Participants were provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation. 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. Nicotine patch: Participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Overall Study STARTED	28
Overall Study Treatment Completed	19
Overall Study Follow-up Completed	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT) All participants in this open trial received individualized heart rate variability biofeedback training (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT). Heart Rate Variability Biofeedback: Participants were provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation. 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. Nicotine patch: Participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Overall Study Withdrawal by Subject	9
Overall Study Lost to Follow-up	3

Baseline Characteristics

Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Baseline characteristics by cohort

Measure	Enrolled n=28 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	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.2 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Data on the Intent-to-treat N=28 participants who completed the baseline session and were enrolled in the study.

Number of intervention sessions attended out of 7 possible sessions.

Outcome measures

Measure	Intent-to-treat Sample n=28 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Intervention Feasibility: Participant Attendance	5.32 Sessions Standard Deviation 2.28	—	—	—	—

PRIMARY outcome

Timeframe: 6 weeks

Population: Data on the Intent-to-treat N=28 participants who completed the baseline session and were enrolled in the study.

Time (in minutes) spent practicing the breathing intervention

Outcome measures

Measure	Intent-to-treat Sample n=28 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Intervention Feasibility: Participant Practice Adherence	8.01 Minutes per day Standard Deviation 6.03	—	—	—	—

PRIMARY outcome

Timeframe: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)

Population: Of the N=28 participants who enrolled in the study, n=27 had available data at Week 1 for this measure; Of the n=19 who completed treatment, n=18 had data available at Week 6; n=16 completed this measure at 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. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived intervention efficacy.

Outcome measures

Measure	Intent-to-treat Sample n=27 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) n=18 Participants Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) n=16 Participants Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Intervention Feasibility: Participant Ratings of Effectiveness	3.02 score on scale Standard Deviation 0.59	3.29 score on scale Standard Deviation 0.59	2.80 score on scale Standard Deviation 0.90	—	—

PRIMARY outcome

Timeframe: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)

Population: Of the N=28 participants who enrolled in the study, n=26 had available data at Week 1 for this measure; Of the n=19 who completed treatment, n=17 had available data at Week 6; n=16 completed this measure at 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. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived intervention appropriateness.

Outcome measures

Measure	Intent-to-treat Sample n=26 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) n=17 Participants Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) n=16 Participants Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Intervention Feasibility: Participant Ratings of Appropriateness	3.46 score on scale Standard Deviation 0.51	3.68 score on scale Standard Deviation 0.47	3.28 score on scale Standard Deviation 0.73	—	—

PRIMARY outcome

Timeframe: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)

Population: Of the N=28 participants who enrolled in the study, n=27 had available data at Week 1 for this measure; Of the n=19 who completed treatment, n=18 had available data at Week 6; n=16 completed this measure at 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. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived ease of the intervention and fit into daily lifestyle.

Outcome measures

Measure	Intent-to-treat Sample n=27 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) n=18 Participants Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) n=16 Participants Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Intervention Feasibility: Participant Ratings of Ease of the Intervention	2.70 score on scale Standard Deviation 0.58	2.58 score on scale Standard Deviation 0.51	2.73 score on scale Standard Deviation 0.65	—	—

PRIMARY outcome

Timeframe: 6 weeks

Population: There was a total of 291 intervention sessions where instances of technical issues could have occurred and been reported.

The intervention used several pieces of technology, including remote session delivery via Zoom, smartphone assisted carbon monoxide (CO) monitor and HRVB devices, remote survey administration, as well as in-person use of biofeedback and physiological monitoring equipment. Technological limitations were assessed via self-report items documenting incidences of technical issues during intervention sessions and their related effects on intervention delivery. Items include Yes/No and open-text responses.

Outcome measures

Measure	Intent-to-treat Sample n=291 Sessions Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Intervention Feasibility: Interventionist Ratings of Technical Issues	117 sessions with 1 or more technical issues	—	—	—	—

PRIMARY outcome

Timeframe: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)

Population: Of the N=28 participants who enrolled in the study, n=27 had available data at Week 1 for this measure; Of the n=19 who completed treatment, n=18 had available data at Week 6; n=16 completed this measure at their 3-month follow up.

Satisfaction and liking will be assessed via self-report items regarding satisfaction with learning the intervention, liking the intervention, breathing techniques, nicotine replacement, and recommending the intervention to others. Items are rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater satisfaction and liking of the intervention and greater perceived intervention acceptability.

Outcome measures

Measure	Intent-to-treat Sample n=27 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) n=18 Participants Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) n=16 Participants Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Intervention Acceptability: Participant Rating of Satisfaction and Liking	3.24 score on scale Standard Deviation 0.56	3.68 score on scale Standard Deviation 0.33	3.45 score on scale Standard Deviation 0.62	—	—

SECONDARY outcome

Timeframe: Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU)

Population: Of the N=28 participants who were eligible and attended their baseline session, n=20, n=19, and n=16 attended and completed this measure at their 2-weeks post-quit, 1-month post-quit, and 3-month follow up sessions.

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. Anxiety: Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, Extremely Severe: 10-21. Stress: Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, Extremely Severe: 17-21. 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 Sample n=28 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) n=20 Participants Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) n=19 Participants Participants who attended their 3-month follow up session.	3-MFU n=16 Participants Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Changes in Total Emotional Distress DASS-21 Total score	12.50 score on scale Standard Deviation 9.76	15.44 score on scale Standard Deviation 7.38	18.16 score on scale Standard Deviation 10.68	21.50 score on scale Standard Deviation 11.70	—
Changes in Total Emotional Distress DASS-21 Depression score	3.39 score on scale Standard Deviation 3.28	3.15 score on scale Standard Deviation 2.82	4.89 score on scale Standard Deviation 4.18	7.06 score on scale Standard Deviation 4.36	—
Changes in Total Emotional Distress DASS-21 Anxiety score	3.57 score on scale Standard Deviation 3.67	4.80 score on scale Standard Deviation 2.63	5.11 score on scale Standard Deviation 3.26	5.69 score on scale Standard Deviation 4.09	—
Changes in Total Emotional Distress DASS-21 Stress score	5.54 score on scale Standard Deviation 4.48	7.49 score on scale Standard Deviation 3.42	8.16 score on scale Standard Deviation 4.66	8.75 score on scale Standard Deviation 4.85	—

SECONDARY outcome

Timeframe: Week 3 (i.e., Quit Date)

Population: Of the N=28 who were eligible and initiated treatment, n=22 attended their quit date.

Quit day abstinence was assessed via self-reported smoking abstinence on Quit Day and verified via carbon monoxide (CO) analysis of breath sample (CO < 8ppm).

Outcome measures

Measure	Intent-to-treat Sample n=22 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Changes in Smoking Behavior: Quit Day Abstinence	8 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 16 (i.e., 3-MFU)

Population: Of the N=28 who were eligible and initiated treatment, n=16 attended their 3-month follow-up session.

Sustained smoking cessation was assessed via self-reported abstinence at 3-months post-quit) and verified via carbon monoxide (CO) analysis (CO < 8ppm) and salivary cotinine levels (<10 ng/mL).

Outcome measures

Measure	Intent-to-treat Sample n=16 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) Participants who attended their 3-month follow up session.	3-MFU Participants who attended their 3-month follow up session.	3-Month Follow Up Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Changes in Smoking Behavior: Sustained Smoking Cessation	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 0, Week 3, Week 5, Week 6, and Week 16 (i.e., Baseline, Quit Date, 2-Weeks Post-Quit, 1-Month Post-Quit, 3-Month follow up)

Population: Of the N=28 participants who were eligible and attended their baseline session, n=22 attended their quit date, n=20 attended their 2-weeks post-quit session, n=19 attended their 1-month post-quit session, and n=16 attended their 3-month follow up.

Cigarettes smoked per day (CPD) assessed via self-report responses on the Timeline Followback interview were used to measure changes in smoking behavior from Baseline through Quit Date, 2-weeks post-quit, 1-month post-quit, and 3-months follow up.

Outcome measures

Measure	Intent-to-treat Sample n=28 Participants Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.	Week 6 (End of Treatment) n=22 Participants Participants who attended their 1-Month Post-Quit session.	Week 16 (3-MFU) n=20 Participants Participants who attended their 3-month follow up session.	3-MFU n=19 Participants Participants who attended their 3-month follow up session.	3-Month Follow Up n=16 Participants Mean CPD at 3-Month Follow-Up was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 3MFU session. Data reflect participants who attended their 3MFU session.
Changes in Smoking Behavior: Reduced Smoking Rate	14.73 Cigarettes smoked per day (CPD) Standard Deviation 7.09	1.14 Cigarettes smoked per day (CPD) Standard Deviation 2.77	1.09 Cigarettes smoked per day (CPD) Standard Deviation 2.00	1.12 Cigarettes smoked per day (CPD) Standard Deviation 2.80	3.30 Cigarettes smoked per day (CPD) Standard Deviation 3.67

Adverse Events

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

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