Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-03 @ 4:48 PM
Study NCT ID:
NCT01525420
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2012-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbricker@fhcrc.org', 'title': 'Jonathan B. Bricker, Ph.D.', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Acceptance & Commitment Therapy (ACT)', 'description': 'ACT\n\nAcceptance \\& Commitment Therapy (ACT): ACT', 'otherNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT\n\nCognitive Behavioral Therapy (CBT): CBT', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'No AE term known- see description', 'notes': 'Unrelated to the study, bipolar participant hospitalized.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Social circumstances'}, {'term': 'No AE term known - see description', 'notes': 'Unrelated to the study, a participant was robbed and hospitalized.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Social circumstances'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Stopped Smoking by 6 Month Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acceptance & Commitment Therapy (ACT)', 'description': 'ACT\n\nAcceptance \\& Commitment Therapy (ACT): ACT'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT\n\nCognitive Behavioral Therapy (CBT): CBT'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': '30-Day point prevalence abstinence at 6 months post treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '7-day and 24-hour Point Prevalence Quit Rates', 'timeFrame': '6-month', 'description': '7-day and 24-hour point prevalence quit rates', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acceptance & Commitment Therapy (ACT)', 'description': 'ACT\n\nAcceptance \\& Commitment Therapy (ACT): ACT\n\nThis is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.'}, {'id': 'FG001', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT\n\nCognitive Behavioral Therapy (CBT): CBT\n\nThis is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acceptance & Commitment Therapy (ACT)', 'description': 'ACT\n\nAcceptance \\& Commitment Therapy (ACT): This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.'}, {'id': 'BG001', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT\n\nCognitive Behavioral Therapy (CBT): ACT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-07', 'studyFirstSubmitDate': '2012-01-31', 'resultsFirstSubmitDate': '2014-03-10', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-10', 'studyFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Stopped Smoking by 6 Month Post Treatment', 'timeFrame': '6 months', 'description': '30-Day point prevalence abstinence at 6 months post treatment'}], 'secondaryOutcomes': [{'measure': '7-day and 24-hour Point Prevalence Quit Rates', 'timeFrame': '6-month', 'description': '7-day and 24-hour point prevalence quit rates'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '35420700', 'type': 'DERIVED', 'citation': 'Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to demonstrate that Acceptance Therapy (ACT's) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).\n\nImplementation outcomes:\n\n* end of treatment and 6-month follow-up data retention rates;\n* intervention implementation quality;\n* number \\& length of calls completed.\n\nComparison of each arm's implementation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 18 and older;\n2. smokes at least 10 cigarettes daily and has done so for at least the past 12 months;\n3. wants to quit smoking in the next 30 days;\n4. willing to be randomly assigned to either group;\n5. willing and able to speak and read in English;\n6. willing and medically eligible to use nicotine replacement therapy (NRT),\n7. currently resides in the U.S., and expects to continue for at least 12 months;\n8. not participating in other smoking cessation interventions;\n9. has regular access to a telephone.\n10. has regular access to an email address.\n\nExclusion Criteria:\n\n* The Exclusion criteria are the opposite of the Inclusion criteria listed above. In addition, the following exclusion criteria also apply:\n\n 1. another member of household enrolled in the study;\n 2. currently using medication or nicotine replacement products to help with quitting smoking;\n 3. currently using any non-cigarette tobacco products;\n 4. pregnant or breastfeeding;\n 5. had a heart attack in last 30 days;\n 6. within the last 6 months, diagnosed with angina, heart pain, or irregular heartbeat;\n 7. serious adverse reactions to nicotine patches including anaphylaxis and related symptoms such as hives, respiratory difficulty, and/or angioedema.'}, 'identificationModule': {'nctId': 'NCT01525420', 'acronym': 'TALK', 'briefTitle': 'Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy', 'orgStudyIdInfo': {'id': '7445'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACT', 'description': 'ACT: This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.', 'interventionNames': ['Behavioral: Acceptance Therapy (ACT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBT', 'description': 'CBT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.', 'interventionNames': ['Other: Cognitive Behavioral Therapy (CBT)']}], 'interventions': [{'name': 'Acceptance Therapy (ACT)', 'type': 'BEHAVIORAL', 'description': 'ACT', 'armGroupLabels': ['ACT']}, {'name': 'Cognitive Behavioral Therapy (CBT)', 'type': 'OTHER', 'description': 'CBT', 'armGroupLabels': ['CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Consumer Wellness Solutions', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Member, Public Health Sciences', 'investigatorFullName': 'Jonathan Bricker', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}