Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34DA043751 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Rate Variability Biofeedback-Smoking Cessation Therapy | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Smoking Cessation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility: Participant Attendance | Number of intervention sessions attended out of 10 possible sessions. | 7 weeks |
| 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) |
| 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) |
| 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) |
| Intervention Acceptability: Participant Ratings of Satisfaction and Liking |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teresa Leyro, Ph.D. | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers, School of Arts and Sciences, One Spring Street | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31055246 | Background | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled | Participants who were eligible and completed the Baseline session |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Feasibility: Participant Attendance | Number of intervention sessions attended out of 10 possible sessions. | 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. | Posted | Mean | Standard Deviation | Sessions | 7 weeks |
|
Baseline (i.e. Week 0), End of Treatment (i.e. Week 7, 1-month post-quit), 3-month follow-up (i.e. Week 16)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled | Participants who were eligible and completed the baseline session | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Teresa Leyro | Rutgers, The State University of New Jersey | 848-445-2090 | tml124@psych.rutgers.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2018 | Jul 1, 2020 | ICF_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2019 | Jul 2, 2020 | Prot_SAP_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001676 | Biofeedback, Psychology |
| D061485 | Tobacco Use Cessation Devices |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
Not provided
Not provided
All participants received individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB).
Not provided
Not provided
This is an open trial with all participants receiving what will become the 'active intervention' in a subsequent randomized clinical trial.
Not provided
|
| Heart Rate Variability Biofeedback (HRVB) | Behavioral | All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation. |
|
|
| Transdermal Nicotine patch | Drug | All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date. |
|
|
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) |
| Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up) |
| 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) |
| 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) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Excluding n=3 participants who withdrew following one intervention session.
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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). | 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. | Posted | Number | participants | 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). | 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 | Posted | Mean | Standard Deviation | Cigarettes smoked per day (CPD) | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D030141 | Feedback, Psychological |
| D004358 | Drug Therapy |
| CO <8 parts per million (PPM) |
|
| t-test, 2 sided | .067 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | 11.9 | Standard Deviation | 8.45 | 2-Sided | 95 | -1.55 | 25.35 | 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. | Other | A paired-samples t-test was used to evaluate smoking reduction in participants from baseline (BL) to 3-month follow-up session (3MFU). |
| DASS-21 Depression score |
|
| DASS-21 Anxiety score |
|
| DASS-21 Stress score |
|
| t-test, 2 sided | .027 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | 31.2 | Standard Deviation | 20.4 | 2-Sided | 95 | 5.88 | 56.52 | 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. | Other | 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). |
| t-test, 2 sided | .045 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | 25.75 | Standard Deviation | 15.5 | 2-Sided | 95 | 1.09 | 50.41 | 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. | Other | 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). |