Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT02997657
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2016-12-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
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All other participants were included in the primary analyses.'}, {'type': 'PRIMARY', 'title': '7-day Point Prevalence Smoking Abstinence at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychotherapy for Smoking Cessation', 'description': 'Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.\n\nPositive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}, {'id': 'OG001', 'title': 'Standard Smoking Cessation Treatment', 'description': 'Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 weeks', 'description': 'Self-reported smoking abstinence biochemically confirmed with CO and cotinine', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.'}, {'type': 'PRIMARY', 'title': 'Continuous Smoking Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychotherapy for Smoking Cessation', 'description': 'Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.\n\nPositive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}, {'id': 'OG001', 'title': 'Standard Smoking Cessation Treatment', 'description': 'Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 weeks', 'description': 'Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.'}, {'type': 'SECONDARY', 'title': 'Engagement in PPT-consistent Quitting Strategies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychotherapy for Smoking Cessation', 'description': 'Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.\n\nPositive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}, {'id': 'OG001', 'title': 'Standard Smoking Cessation Treatment', 'description': 'Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '3.88', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '4.07', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'During treatment - weeks 1-4 after quit date', 'description': 'Engaging in strategies consistent with the positive psychology exercises taught in the trial. 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One participant in the Positive Psychotherapy condition completed the final session but did not complete this measure.'}, {'type': 'SECONDARY', 'title': 'Residual Attraction to Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychotherapy for Smoking Cessation', 'description': 'Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.\n\nPositive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}, {'id': 'OG001', 'title': 'Standard Smoking Cessation Treatment', 'description': 'Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At end of treatment (4 weeks after quit date)', 'description': 'Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed.'}, {'type': 'SECONDARY', 'title': 'Self-efficacy for Resisting Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychotherapy for Smoking Cessation', 'description': 'Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.\n\nPositive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}, {'id': 'OG001', 'title': 'Standard Smoking Cessation Treatment', 'description': 'Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.\n\nStandard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '3.76', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '3.80', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At end of treatment (4 weeks after quit date)', 'description': 'Self-reported confidence in remaining abstinent from smoking. 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'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Self report measure of cigarette dependence with scores ranging from 0 to 10, where 10 is the highest level of dependence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CES-D Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '12.1', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '12.6', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Center for Epidemiologic Studies-Depression Scale, total score. This 20-item scale has total scores ranging from 0-60 with higher scores indicating more severe depresssive symptoms. A score of 16 of greater is typically used to indicate possible major depressive disorder.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-22', 'size': 261013, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-22T18:50', 'hasProtocol': True}, {'date': '2022-12-22', 'size': 174373, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-22T18:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2016-12-05', 'resultsFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2016-12-15', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-06', 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day Point Prevalence Smoking Abstinence at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Self-reported smoking abstinence biochemically confirmed with CO and cotinine'}, {'measure': '7-day Point Prevalence Smoking Abstinence at 26 Weeks', 'timeFrame': '26 weeks', 'description': 'Self-reported smoking abstinence biochemically confirmed with CO and cotinine'}, {'measure': '7-day Point Prevalence Smoking Abstinence at 52 Weeks', 'timeFrame': '52 weeks', 'description': 'Self-reported smoking abstinence biochemically confirmed with CO and cotinine'}, {'measure': 'Continuous Smoking Abstinence', 'timeFrame': '52 weeks', 'description': 'Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Engagement in PPT-consistent Quitting Strategies', 'timeFrame': 'During treatment - weeks 1-4 after quit date', 'description': 'Engaging in strategies consistent with the positive psychology exercises taught in the trial. Nine strategies are assessed on 1 to 5 scale with 5 reflecting greater use of the strategies. The total score is the average across the 9 item.'}, {'measure': 'Residual Attraction to Smoking', 'timeFrame': 'At end of treatment (4 weeks after quit date)', 'description': 'Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction.'}, {'measure': 'Self-efficacy for Resisting Smoking', 'timeFrame': 'At end of treatment (4 weeks after quit date)', 'description': 'Self-reported confidence in remaining abstinent from smoking. The 9-item scale uses a 1-5 response scale and the total score is the average of those 9 responses, where higher scores represent higher confidence in resisting smoking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions), while also providing skills that may buffer against stress and negative affect. The overall objective of this project is to conduct a randomized controlled trial to test the efficacy of PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation treatment. Participants in both treatment conditions will receive nicotine replacement therapy and a validated text-messaging intervention for smoking cessation that monitors progress in quitting smoking and extends smoking counseling outside of the individual face-to-face context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. be 18 years of age or older\n2. smoke at least 5 cigarettes per day for longer than one year with no current regular use of other nicotine/tobacco products including e-cigarettes\n3. have a baseline carbon monoxide level of at least 4 ppm\n4. be willing to use the nicotine patch\n5. report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking (where 10 = extremely important);\n6. have an active cell phone and be willing to send and receive text messages for the duration of the intervention.\n\nExclusion Criteria:\n\n1\\. Contact study site for details'}, 'identificationModule': {'nctId': 'NCT02997657', 'briefTitle': 'Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'R01CA201262', 'link': 'https://reporter.nih.gov/quickSearch/R01CA201262', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive Psychotherapy for Smoking Cessation', 'description': 'Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.', 'interventionNames': ['Behavioral: Positive Psychotherapy', 'Behavioral: Standard smoking cessation counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard smoking cessation treatment', 'description': 'Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.', 'interventionNames': ['Behavioral: Standard smoking cessation counseling']}], 'interventions': [{'name': 'Positive Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Exercises designed to boost moods, positive behaviors, and positive cognitions.', 'armGroupLabels': ['Positive Psychotherapy for Smoking Cessation']}, {'name': 'Standard smoking cessation counseling', 'type': 'BEHAVIORAL', 'description': 'Counseling designed to provide support and problem solving for smoking cessation', 'armGroupLabels': ['Positive Psychotherapy for Smoking Cessation', 'Standard smoking cessation treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Partners Healthcare and Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Center for Alcohol and Addiction Studies, Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Christopher Kahler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Truth Initiative', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christopher W. Kahler', 'investigatorAffiliation': 'Brown University'}}}}