Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-04-21 @ 11:45 AM
Study NCT ID:
NCT05224050
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2021-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Heart Rate Variability Biofeedback for Smoking Cessation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tml124@psych.rutgers.edu', 'phone': '848-445-2090', 'title': 'Dr. Teresa Leyro', 'organization': 'Rutgers, The State University of New Jersey'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '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).', 'eventGroups': [{'id': 'EG000', 'title': 'Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)', 'description': '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).\n\nCognitive-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.\n\nHeart Rate Variability Biofeedback: Participants was provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.\n\nNicotine patch: All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intervention Feasibility: Participant Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent-to-treat Sample', 'description': 'Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.32', 'spread': '2.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Number of intervention sessions attended out of 7 possible sessions.', 'unitOfMeasure': 'Sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on the Intent-to-treat N=28 participants who completed the baseline session and were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Intervention Feasibility: Participant Practice Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent-to-treat Sample', 'description': 'Participants who completed their baseline session, enrolled, and completed at least one session of the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.01', 'spread': '6.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Time (in minutes) spent practicing the breathing intervention', 'unitOfMeasure': 'Minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on the Intent-to-treat N=28 participants who completed the baseline session and were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Intervention Feasibility: Participant Ratings of Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Week 1 (Treatment Initiation)', 'description': 'Participants who enrolled and attended their first intervention session.'}, {'id': 'OG001', 'title': 'Week 6 (End of Treatment)', 'description': 'Participants who attended their 1-Month Post-Quit session.'}, {'id': 'OG002', 'title': 'Week 16 (3-MFU)', 'description': 'Participants who attended their 3-month follow up session.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '2.80', 'spread': '0.90', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', '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)', '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. 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.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Intervention Feasibility: Participant Ratings of Appropriateness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Week 1 (Treatment Initiation)', 'description': 'Participants who enrolled and attended their first intervention session.'}, {'id': 'OG001', 'title': 'Week 6 (End of Treatment)', 'description': 'Participants who attended their 1-month Post-Quit session.'}, {'id': 'OG002', 'title': 'Week 16 (3-MFU)', 'description': 'Participants who attended their 3-month follow up session.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.46', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '3.68', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '3.28', 'spread': '0.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', '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)', '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. 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.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Intervention Feasibility: Participant Ratings of Ease of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Week 1 (Treatment Initiation)', 'description': 'Participants who enrolled and attended their first intervention session.'}, {'id': 'OG001', 'title': 'Week 6 (End of Treatment)', 'description': 'Participants who attended their 1-month Post-Quit session.'}, {'id': 'OG002', 'title': 'Week 16 (3-MFU)', 'description': 'Participants who attended their 3-month follow up session.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '2.73', 'spread': '0.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', '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)', '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. 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.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Intervention Feasibility: Interventionist Ratings of Technical Issues', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Sessions', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventionist Reports of Technical Issues', 'description': 'Total number of intervention sessions where Interventionists could have experienced and reported technical issues'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': '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.', 'unitOfMeasure': 'sessions with 1 or more technical issues', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sessions', 'denomUnitsSelected': 'Sessions', 'populationDescription': 'There was a total of 291 intervention sessions where instances of technical issues could have occurred and been reported.'}, {'type': 'PRIMARY', 'title': 'Intervention Acceptability: Participant Rating of Satisfaction and Liking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Week 1 (Treatment Initiation)', 'description': 'Participants who enrolled and attended their first intervention session.'}, {'id': 'OG001', 'title': 'Week 6 (End of Treatment)', 'description': 'Participants who attended their 1-month Post-Quit session.'}, {'id': 'OG002', 'title': 'Week 16 (3-MFU)', 'description': 'Participants who attended their 3-month follow up session.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.24', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '3.68', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '3.45', 'spread': '0.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', '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)', 'description': '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.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Changes in Total Emotional Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Participants who attended their baseline visit'}, {'id': 'OG001', 'title': '2-Weeks Post-Quit', 'description': 'Participants who attended their 2-weeks Post-Quit session.'}, {'id': 'OG002', 'title': '1-Month Post-Quit', 'description': 'Participants who attended their 1-month Post-Quit session.'}, {'id': 'OG003', 'title': '3-MFU', 'description': 'Participants who attended their 3-month follow up session.'}], 'classes': [{'title': 'DASS-21 Total score', 'categories': [{'measurements': [{'value': '12.50', 'spread': '9.76', 'groupId': 'OG000'}, {'value': '15.44', 'spread': '7.38', 'groupId': 'OG001'}, {'value': '18.16', 'spread': '10.68', 'groupId': 'OG002'}, {'value': '21.50', 'spread': '11.70', 'groupId': 'OG003'}]}]}, {'title': 'DASS-21 Depression score', 'categories': [{'measurements': [{'value': '3.39', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '2.82', 'groupId': 'OG001'}, {'value': '4.89', 'spread': '4.18', 'groupId': 'OG002'}, {'value': '7.06', 'spread': '4.36', 'groupId': 'OG003'}]}]}, {'title': 'DASS-21 Anxiety score', 'categories': [{'measurements': [{'value': '3.57', 'spread': '3.67', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '2.63', 'groupId': 'OG001'}, {'value': '5.11', 'spread': '3.26', 'groupId': 'OG002'}, {'value': '5.69', 'spread': '4.09', 'groupId': 'OG003'}]}]}, {'title': 'DASS-21 Stress score', 'categories': [{'measurements': [{'value': '5.54', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '7.49', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '8.16', 'spread': '4.66', 'groupId': 'OG002'}, {'value': '8.75', 'spread': '4.85', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.04', 'ciLowerLimit': '-6.98', 'ciUpperLimit': '2.89', 'pValueComment': 'The threshold for statistical significance was p\\<0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10.54', 'estimateComment': 'Mean difference represents the difference of the mean for the DASS-21 total scores at Baseline and at 2-weeks post-quit. The reported estimated value is based on data from the n=20 who attended their 2-weeks post-quit session', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A paired-samples t-test was conducted to examine differences in the DASS-21 total score from baseline to 2-weeks post-quit.'}, {'pValue': '0.26', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.43', 'ciLowerLimit': '-6.84', 'ciUpperLimit': '1.98', 'pValueComment': 'The threshold for statistical significance was p \\< 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.15', 'estimateComment': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '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.'}, {'pValue': '0.11', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.75', 'ciLowerLimit': '-6.21', 'ciUpperLimit': '0.71', 'pValueComment': 'The threshold for statistical significance was p \\< 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.49', 'estimateComment': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '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.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU)', '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. 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.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Changes in Smoking Behavior: Quit Day Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quit Date', 'description': 'Participants who attended their Quit day session'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 3 (i.e., Quit Date)', 'description': '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the N=28 who were eligible and initiated treatment, n=22 attended their quit date.'}, {'type': 'SECONDARY', 'title': 'Changes in Smoking Behavior: Sustained Smoking Cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3-Month Follow Up', 'description': 'Participants who attended their 3-month follow-up session.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16 (i.e., 3-MFU)', 'description': '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the N=28 who were eligible and initiated treatment, n=16 attended their 3-month follow-up session.'}, {'type': 'SECONDARY', 'title': 'Changes in Smoking Behavior: Reduced Smoking Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': "Mean CPD at baseline was determined by averaging the total number of cigarettes smoked per day for the 28 days prior to the participant's baseline session. Data reflect participants who attended their baseline session and enrolled in the study."}, {'id': 'OG001', 'title': 'Quit Date', 'description': '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.'}, {'id': 'OG002', 'title': '2-Weeks Post-Quit', 'description': "Mean CPD at 2-Weeks Post-Quit was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 2-weeks post-quit session. Data reflect participants who attended their 2-weeks post-quit session."}, {'id': 'OG003', 'title': '1-Month Post-Quit', 'description': "Mean CPD at 1-Month Post-Quit was determined by averaging the total number of cigarettes smoked per day for the 7 days prior to the participant's 1-month post-quit session. Data reflect participants who attended their 1-month post-quit session."}, {'id': 'OG004', 'title': '3-Month Follow Up', 'description': "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."}], 'classes': [{'categories': [{'measurements': [{'value': '14.73', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '2.00', 'groupId': 'OG002'}, {'value': '1.12', 'spread': '2.80', 'groupId': 'OG003'}, {'value': '3.30', 'spread': '3.67', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.70', 'ciLowerLimit': '9.88', 'ciUpperLimit': '17.53', 'pValueComment': 'The threshold for statistical significance was p \\< 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.63', 'estimateComment': 'Mean difference represents the average difference in cigarettes smoked per day from Baseline to Quit Date. The reported estimated value is based on data from the n=22 participants who attended their Quit Date session.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline to Quit Day.'}, {'pValue': '0.80', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '1.06', 'pValueComment': 'The threshold for statistical significance was p \\< 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.02', 'estimateComment': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A paired-samples t-test was used to evaluate smoking reduction in participants from Quit Date to 2-weeks Post-Quit.'}, {'pValue': '0.97', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '1.45', 'pValueComment': 'The threshold for statistical significance was p \\< 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.97', 'estimateComment': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A paired-samples t-test was used to evaluate smoking reduction in participants from 2-weeks post-quit to 1=month post-quit.'}, {'pValue': '0.04', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.17', 'ciLowerLimit': '-4.17', 'ciUpperLimit': '-0.17', 'pValueComment': 'The threshold for statistical significance was p \\< 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.75', 'estimateComment': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A paired-samples t-test was used to evaluate smoking reduction in participants from 1-month post-quit to 3-month follow-up.'}], 'paramType': 'MEAN', '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)', 'description': '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.', 'unitOfMeasure': 'Cigarettes smoked per day (CPD)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)', 'description': '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).\n\nHeart Rate Variability Biofeedback: Participants were provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.\n\nCognitive-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.\n\nNicotine patch: Participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Treatment Completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Follow-up Completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled', 'description': 'Participants who were eligible and completed the Baseline session'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-28', 'size': 551339, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-12T12:54', 'hasProtocol': True}, {'date': '2023-01-25', 'size': 610667, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-12T12:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open trial with all participants receiving the experimental intervention (HRVB) in addition to smoking cessation therapy and nicotine replacement therapy patch.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2021-12-13', 'resultsFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-29', 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Feasibility: Participant Attendance', 'timeFrame': '6 weeks', 'description': 'Number of intervention sessions attended out of 7 possible sessions.'}, {'measure': 'Intervention Feasibility: Participant Practice Adherence', 'timeFrame': '6 weeks', 'description': 'Time (in minutes) spent practicing the breathing intervention'}, {'measure': 'Intervention Feasibility: Participant Ratings of Effectiveness', '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)', '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. 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.'}, {'measure': 'Intervention Feasibility: Participant Ratings of Appropriateness', '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)', '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. 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.'}, {'measure': 'Intervention Feasibility: Participant Ratings of Ease of the Intervention', '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)', '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. 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': 'Intervention Feasibility: Interventionist Ratings of Technical Issues', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Intervention Acceptability: Participant Rating of Satisfaction and Liking', '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)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in Total Emotional Distress', 'timeFrame': 'Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU)', '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. 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.'}, {'measure': 'Changes in Smoking Behavior: Quit Day Abstinence', 'timeFrame': 'Week 3 (i.e., Quit Date)', 'description': '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).'}, {'measure': 'Changes in Smoking Behavior: Sustained Smoking Cessation', 'timeFrame': 'Week 16 (i.e., 3-MFU)', 'description': '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).'}, {'measure': 'Changes in Smoking Behavior: Reduced Smoking Rate', '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)', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Heart Rate Variability Biofeedback'], 'conditions': ['Tobacco Smoking']}, 'referencesModule': {'references': [{'pmid': '31055246', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 21-50\n* Smoking ≥ 5 cigarettes, daily, for at least two years\n* Expired carbon monoxide analysis of breath sample ≥8 ppm\n* A score of \\> 5 on the Readiness to Quit Ladder (i.e., desire to quit smoking within the next 6 months)\n* Ability to read and speak English fluently\n* Computer and Smartphone proficient\n\nExclusion Criteria:\n\n* Use of other tobacco or nicotine products for recreation or to aid in cessation or use of medication to aid in smoking cessation or currently receiving counseling for smoking cessation\n* Endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation\n* Self-reported pending legal issue with potential to result in incarceration\n* Plan to move from the New Brunswick, New Jersey area within the next 6 months\n* Inability to provide written informed consent\n* Current evidence of another substance use disorder\n* Severe visual or hearing impairments\n* Self-reported medical condition or medication use that may be contraindicated for participation in heart rate variability biofeedback training or confound autonomic parameters: Being overweight or obese (i.e., body mass index \\> 35); Severe asthma or breathing problems (e.g., chronic obstructive pulmonary disease, emphysema, bronchitis); currently pregnant or lactating or plans to become pregnant in the next 4 months; Autoimmune disorder (e.g., multiple sclerosis; under or overactive thyroid); Neurodegenerative disorder (e.g., Alzheimer's disease, Parkinson's disease); Current use of a psychotropic medication or use of other medication that may affect the cardiovascular system (e.g., mood stabilizers, anti-psychotics, monoamine oxidase inhibitors, tricyclics, beta blockers, benzodiazepines; patients taking selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors will be enrolled if on a stable regimen for at least 6 weeks); History of heart murmur or arrhythmia; Pacemaker or other implanted cardiac devices; Heart disease; or Abnormal heart or respiratory parameters including respiration rate \\> 20 breaths per minute, extra systoles, or hypertension (e.g., blood pressure reading ≥ 140/90; this may be determined following baseline assessment. Importantly, the presence of any of these exclusion factors, if unknown to the participant would not put them at any risk if they participated in the study, it would simply make the cardiovascular data more difficult (if not impossible) to process and interpret, and\n* Self-reported medical issues of potential concern to nicotine patch users (i.e., unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days"}, 'identificationModule': {'nctId': 'NCT05224050', 'acronym': 'HRVB-SCT', 'briefTitle': 'Heart Rate Variability Biofeedback for Smoking Cessation Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Open Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment', 'orgStudyIdInfo': {'id': 'Pro2019001539'}, 'secondaryIdInfos': [{'id': '5R34DA043751-03', 'link': 'https://reporter.nih.gov/quickSearch/5R34DA043751-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)', 'description': '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).', 'interventionNames': ['Behavioral: Cognitive-Behavioral Smoking Cessation', 'Biological: Heart Rate Variability Biofeedback', 'Drug: Nicotine patch']}], 'interventions': [{'name': 'Cognitive-Behavioral Smoking Cessation', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive-behavioral therapy', 'Smoking cessation counseling'], 'description': '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.', 'armGroupLabels': ['Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)']}, {'name': 'Heart Rate Variability Biofeedback', 'type': 'BIOLOGICAL', 'otherNames': ['Biofeedback', 'Respiratory biofeedback'], 'description': 'Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.', 'armGroupLabels': ['Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)']}, {'name': 'Nicotine patch', 'type': 'DRUG', 'otherNames': ['Transdermal nicotine patch', 'Nicotine replacement therapy'], 'description': 'All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.', 'armGroupLabels': ['Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers, School of Arts and Sciences, One Spring Street', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Teresa M, Leyro, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Teresa M. Leyro, Ph.D.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}