Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT02750904
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2016-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-10', 'studyFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': 'Week -1 (Visit 0)', 'description': 'Number approached, screened, eligible, and consented; reasons for ineligibility or refusal'}, {'measure': 'Recruitment', 'timeFrame': 'Week 0 (Visit 1)', 'description': 'Number approached, screened, eligible, and consented; reasons for ineligibility or refusal'}, {'measure': 'Completion of the experimental intervention', 'timeFrame': 'Week 10', 'description': 'Completion of the core treatment program'}, {'measure': 'Retention in study', 'timeFrame': 'Week 10', 'description': 'Percentage of participants in each arm completing outcome assessments at end of treatment visit'}, {'measure': 'Retention in study', 'timeFrame': 'Week 14', 'description': 'Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit'}, {'measure': 'Treatment satisfaction', 'timeFrame': 'Week 10', 'description': '12 item survey used in our prior work assessing satisfaction with the assigned treatment'}, {'measure': 'Treatment utilization', 'timeFrame': 'Week 10', 'description': 'Server-recorded log-ins to the assigned treatment'}, {'measure': 'Change in acceptance of smoking triggers', 'timeFrame': 'Week 10', 'description': 'Change in acceptance scores between baseline and end of treatment'}, {'measure': 'Change in commitment to quit', 'timeFrame': 'Week 10', 'description': 'Change in commitment scores between baseline and end of treatment'}, {'measure': 'CO-confirmed 7-day point prevalence abstinence from cigarette smoking', 'timeFrame': 'Weeks 10', 'description': 'Preliminary efficacy for smoking cessation'}, {'measure': 'CO-confirmed 7-day point prevalence abstinence from cigarette smoking', 'timeFrame': 'Week 14', 'description': 'Preliminary efficacy for smoking cessation'}, {'measure': 'Change in bipolar disorder symptoms', 'timeFrame': 'Week 10', 'description': 'Change in mania and depression scale scores'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Acceptance & Commitment Therapy', 'Cognitive Behavioral Therapy', 'Bipolar Disorder'], 'conditions': ['Smoking', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.', 'detailedDescription': 'The study consist of two separate phases. Phase I consists of website usability testing. Investigators will collect feedback and incorporate the feedback into our website that is tailored for people with bipolar disorder. In Phase II investigators will be comparing quit rates of two groups both utilizing Nicotine Replacement Therapy and a website.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older\n2. Daily smoker for the past year, averaging at least 5 cigarettes per day for the past 30 days, with expired-air carbon monoxide (CO) level ≥ 4 ppm\n3. Motivated to quit smoking (i.e., endorse plans to quit in the next 30 days at the time of phone pre-screening)\n4. Meets lifetime criteria for bipolar I or II disorder, based on DSM-V criteria\n5. Willing to be randomly assigned to either treatment group\n6. Has at least weekly access to a high-speed Internet connection via a tablet, laptop or desktop computer\n7. Willing and able to read in English\n8. Is under care of a clinician for the treatment of bipolar disorder\n9. Willing to authorize communication with the clinician regarding study participation and clinical deterioration\n10. Willing to use the nicotine patch to help quit smoking\n\nExclusion Criteria:\n\n1. Participating in other smoking cessation interventions\n2. Currently using any pharmacotherapies for smoking cessation\n3. Previous use of the Smokefree.gov website\n4. Meets DSM-V criteria for current mania\n5. Meets DSM-V criteria for a current major depressive episode and symptoms are currently severe (Patient Health Questionnaire-9 score \\> 14)\n6. Current psychotic symptoms\n7. Psychiatric hospitalization within one month prior to enrollment\n8. Current suicidal or homicidal ideation\n9. Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in past month prior to enrollment\n10. Unstable medical condition\n11. Any medical or psychiatric condition that, in the opinion of the investigator, is severe enough to interfere with protocol adherence or ability to benefit from the intervention\n12. Any medical conditions that would preclude use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)\n13. Employee or family member of the investigator or study center, or member of the same household as another research participant'}, 'identificationModule': {'nctId': 'NCT02750904', 'acronym': 'WebQuit Plus', 'briefTitle': 'Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder', 'orgStudyIdInfo': {'id': 'IR File# 8363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental therapy', 'interventionNames': ['Behavioral: Experimental plus Nicotine Replacement Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Therapy', 'interventionNames': ['Behavioral: Control plus Nicotine Replacement Therapy']}], 'interventions': [{'name': 'Experimental plus Nicotine Replacement Therapy', 'type': 'BEHAVIORAL', 'description': 'Behavioral: Experimental plus Nicotine Replacement Therapy will be built to specifically address challenges of smoking cessation for individuals with bipolar disorder.\n\nIncludes four in person and four phone visits.\n\nTherapy information is withheld to protect the integrity of the study.', 'armGroupLabels': ['Experimental therapy']}, {'name': 'Control plus Nicotine Replacement Therapy', 'type': 'BEHAVIORAL', 'description': 'Includes four in-person and four phone visits', 'armGroupLabels': ['Control Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Veterans Institute for Research', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80228', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Jefferson Center for Mental Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '01730', 'city': 'Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Bedford VA Research Corp', 'geoPoint': {'lat': 42.49065, 'lon': -71.27617}}, {'zip': '01503', 'city': 'Leeds', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Central Western Massachusetts Healthcare System', 'geoPoint': {'lat': 42.35148, 'lon': -72.69954}}], 'overallOfficials': [{'name': 'Jaimee Heffner, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Palo Alto Veterans Institute for Research', 'class': 'OTHER'}, {'name': 'Bedford Research Corporation, Inc.', 'class': 'OTHER'}, {'name': 'Jefferson Center, Community Mental Health Clinic', 'class': 'UNKNOWN'}, {'name': 'VA Central Western Massachusetts Healthcare System', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}