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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34DA043751-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of the study is to conduct an open trial examining the feasibility and acceptability of an adapted heart rate variability biofeedback and smoking cessation treatment that was using a primarily virtual remote intervention.
The present investigation is an open trial investigating the feasibility and acceptability of heart rate variability biofeedback smoking cessation treatment (HRVB-SCT) for individuals who smoke cigarettes. Significant findings will also support the expansion of HRVB as a transdiagnostic treatment adjunct that alters cardiac vagal functioning to promote emotional and behavioral regulation, changing the status quo of cognitive-behavioral intervention approaches and decreasing the health and economic burden of smokers who suffer from emotional distress.
The goals are to: (a) assess the feasibility and acceptability of the HRVB-SCT intervention (b) assess the efficacy of the intervention in modifying smoking behavior and emotional distress; and (c) collect additional information to inform a subsequent randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT) | Experimental | All participants in this open trial will receive individualized training in resonance breathing using biofeedback to help improve self-regulation (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Smoking Cessation | Behavioral | Participants will be 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 7 possible sessions. | 6 weeks |
| Intervention Feasibility: Participant Practice Adherence | Time (in minutes) spent practicing the breathing intervention | 6 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. 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. | Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU) |
| 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. 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. | Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU) |
| 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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes 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. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa M, 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled | Participants who were eligible and completed the Baseline session |
| Units | Counts |
|---|---|
| Participants |
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| 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 7 possible sessions. | Data on the Intent-to-treat N=28 participants who completed the baseline session and were enrolled in the study. | Posted | Mean | Standard Deviation | Sessions | 6 weeks |
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Baseline (i.e., Week 0), End-of-Treatment (i.e., Week 6, 1-month post-quit), 2-Month Follow Up (i.e., Week 16, 3-months post-quit).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT) | All participants in this open trial received individualized training in resonance breathing using biofeedback to help improve self-regulation (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT). Cognitive-Behavioral Smoking Cessation: Participants was 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: Participants was provided with seven individualized trainings 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Teresa Leyro | Rutgers, The State University of New Jersey | 848-445-2090 | tml124@psych.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2022 | Feb 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2023 | Feb 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 | Health Behavior |
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| 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 |
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All participants will receive individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB)
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This is an open trial with all participants receiving the experimental intervention (HRVB) in addition to smoking cessation therapy and nicotine replacement therapy patch.
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| Heart Rate Variability Biofeedback | Biological | Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation. |
|
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| Nicotine patch | Drug | All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date. |
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| Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU) |
| Intervention Feasibility: Interventionist Ratings of Technical Issues | 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. | 6 weeks |
| Intervention Acceptability: Participant Rating of Satisfaction and Liking | 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. | Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU) |
| Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU) |
| Changes in Smoking Behavior: Quit Day Abstinence | 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). | Week 3 (i.e., Quit Date) |
| Changes in Smoking Behavior: Sustained Smoking Cessation | 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). | Week 16 (i.e., 3-MFU) |
| Changes in Smoking Behavior: Reduced Smoking Rate | 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. | 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) |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Intervention Feasibility: Participant Practice Adherence | Time (in minutes) spent practicing the breathing intervention | Data on the Intent-to-treat N=28 participants who completed the baseline session and were enrolled in the study. | Posted | Mean | Standard Deviation | Minutes per day | 6 weeks |
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| 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. 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. | 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. | Posted | Mean | Standard Deviation | score on scale | Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU) |
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| 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. 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. | 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. | Posted | Mean | Standard Deviation | score on scale | Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU) |
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| 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. 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. | 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. | Posted | Mean | Standard Deviation | score on scale | Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU) |
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| Primary | Intervention Feasibility: Interventionist Ratings of Technical Issues | 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. | There was a total of 291 intervention sessions where instances of technical issues could have occurred and been reported. | Posted | Number | sessions with 1 or more technical issues | 6 weeks | Sessions | Sessions |
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| Primary | Intervention Acceptability: Participant Rating of Satisfaction and Liking | 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. | 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. | Posted | Mean | Standard Deviation | score on scale | Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU) |
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| Secondary | Changes 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. 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. | 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. | Posted | Mean | Standard Deviation | score on scale | Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU) |
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| Secondary | Changes in Smoking Behavior: Quit Day Abstinence | 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). | Of the N=28 who were eligible and initiated treatment, n=22 attended their quit date. | Posted | Count of Participants | Participants | Week 3 (i.e., Quit Date) |
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| Secondary | Changes in Smoking Behavior: Sustained Smoking Cessation | 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). | Of the N=28 who were eligible and initiated treatment, n=16 attended their 3-month follow-up session. | Posted | Count of Participants | Participants | Week 16 (i.e., 3-MFU) |
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| Secondary | Changes in Smoking Behavior: Reduced Smoking Rate | 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. | 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. | Posted | Mean | Standard Deviation | Cigarettes smoked per day (CPD) | 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) |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D030141 | Feedback, Psychological |
| D004358 | Drug Therapy |
| DASS-21 Depression score |
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| DASS-21 Anxiety score |
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| DASS-21 Stress score |
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| t-test, 2 sided | 0.26 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | -2.43 | Standard Deviation | 9.15 | 2-Sided | 95 | -6.84 | 1.98 | Mean difference represents the difference of mean DASS-21 total scores at 2-weeks post-quit and 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session. | Other | A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 2-weeks post-quit to 1-month post-quit. |
| t-test, 2 sided | 0.11 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | -2.75 | Standard Deviation | 6.49 | 2-Sided | 95 | -6.21 | 0.71 | Mean difference represents the difference of mean DASS-21 total scores at 1-month post-quit and 3-month follow up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow up session. | Other | A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 1-month post-quit to 3-month follow up. |
| t-test, 2 sided | 0.80 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | 0.11 | Standard Deviation | 2.02 | 2-Sided | 95 | -0.83 | 1.06 | Mean difference represents the average difference in cigarettes smoked per day from Quit Date to 2-weeks Post-Quit. The reported estimated value is based on data from the n=20 participants who attended their 2-weeks post-quit session. | Other | A paired-samples t-test was used to evaluate smoking reduction in participants from Quit Date to 2-weeks Post-Quit. |
| t-test, 2 sided | 0.97 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | 0.02 | Standard Deviation | 2.97 | 2-Sided | 95 | -1.41 | 1.45 | Mean difference represents the average difference in cigarettes smoked per day from 2-weeks post-quit to 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session. | Other | A paired-samples t-test was used to evaluate smoking reduction in participants from 2-weeks post-quit to 1=month post-quit. |
| t-test, 2 sided | 0.04 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | -2.17 | Standard Deviation | 3.75 | 2-Sided | 95 | -4.17 | -0.17 | Mean difference represents the average difference in cigarettes smoked per day from 1-month post-quit to 3-month follow-up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow-up session. | Other | A paired-samples t-test was used to evaluate smoking reduction in participants from 1-month post-quit to 3-month follow-up. |