Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-31 @ 2:12 PM
Study NCT ID:
NCT06443294
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Smoking Cessation Video Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Quantity/Frequency', 'timeFrame': 'Measured at baseline and 30 days following completion of video series.', 'description': 'Cigarettes smoked in past 30 days.'}, {'measure': 'Subjective Reactions to Video Series', 'timeFrame': 'Measured upon completion of video series, within 2 weeks of beginning study.', 'description': "Scale based on measure previously developed and used by PI of this study (Schmidt et al., 2023). Outcome explores participants' experience with and opinions of video intervention (e.g., video helpfulness, clarity, etc.)."}, {'measure': 'Self-Efficacy Questionnaire', 'timeFrame': 'Measured upon completion of video series (within 2 weeks of beginning study) and at 30-day follow-up.', 'description': "Participants' belief in their ability to avoid smoking. SEQ-12: Etter et al., 2000)"}], 'secondaryOutcomes': [{'measure': 'The Working Alliance Inventory for Guided Internet Interventions', 'timeFrame': 'Measured upon completion of video series, within 2 weeks of beginning study.', 'description': "Participants' sense of alliance with therapist leading video intervention. (WAI-I: Penedo et al., 2020)."}, {'measure': 'Motivation to Quit Smoking (Change Ladder)', 'timeFrame': 'Measured upon completion of video series (within 2 weeks of beginning study) and one-month follow-up.', 'description': "Participants' level of motivation to change smoking behavior measured using a stages of change ladder based in Motivational Interviewing principles."}, {'measure': 'Smoking Quit Attempt', 'timeFrame': 'Measured at 30-day follow-up.', 'description': 'Whether participants made a quit attempt during the course of the study. Measured using a single, "yes or no" item asking whether participants attempted to quit smoking in the past month.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Cessation', 'Tobacco Smoking']}, 'referencesModule': {'references': [{'pmid': '24237915', 'type': 'BACKGROUND', 'citation': 'Abroms LC, Lee Westmaas J, Bontemps-Jones J, Ramani R, Mellerson J. A content analysis of popular smartphone apps for smoking cessation. Am J Prev Med. 2013 Dec;45(6):732-6. doi: 10.1016/j.amepre.2013.07.008.'}, {'pmid': '36811984', 'type': 'BACKGROUND', 'citation': 'Burman A, Haeder SF, Xu WY. Provider directory inaccuracy and timely access for mental health care. Am J Manag Care. 2023 Feb;29(2):96-102. doi: 10.37765/ajmc.2023.89318.'}, {'pmid': '28727663', 'type': 'BACKGROUND', 'citation': 'Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338.'}, {'pmid': '37079352', 'type': 'BACKGROUND', 'citation': 'Guo YQ, Chen Y, Dabbs AD, Wu Y. The Effectiveness of Smartphone App-Based Interventions for Assisting Smoking Cessation: Systematic Review and Meta-analysis. J Med Internet Res. 2023 Apr 20;25:e43242. doi: 10.2196/43242.'}, {'pmid': '26298552', 'type': 'BACKGROUND', 'citation': 'Lee EB, An W, Levin ME, Twohig MP. An initial meta-analysis of Acceptance and Commitment Therapy for treating substance use disorders. Drug Alcohol Depend. 2015 Oct 1;155:1-7. doi: 10.1016/j.drugalcdep.2015.08.004. Epub 2015 Aug 13.'}, {'pmid': '31599606', 'type': 'BACKGROUND', 'citation': 'Magill M, Ray L, Kiluk B, Hoadley A, Bernstein M, Tonigan JS, Carroll K. A meta-analysis of cognitive-behavioral therapy for alcohol or other drug use disorders: Treatment efficacy by contrast condition. J Consult Clin Psychol. 2019 Dec;87(12):1093-1105. doi: 10.1037/ccp0000447. Epub 2019 Oct 10.'}, {'pmid': '21599505', 'type': 'BACKGROUND', 'citation': 'Richardson CG, Vettese L, Sussman S, Small SP, Selby P. An investigation of smoking cessation video content on YouTube. Subst Use Misuse. 2011;46(7):893-7. doi: 10.3109/10826084.2011.570628.'}]}, 'descriptionModule': {'briefSummary': "This study seeks to develop and test an internet video series aimed at helping individuals reduce cigarette smoking. Participants (daily smokers) will be asked to watch a series of six videos (approximately 6.5 minutes each) which cover various empirically-supported smoking cessation strategies and tools. Examples of strategies included in the videos include noticing smoking cues and consequences and relaxation training. Participants' demographic information, motivation to change, reactions to the video series alliance with video therapist, and confidence in avoiding smoking will all be measured. Additionally, participants will be asked to report their smoking behavior at study baseline and follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Daily smoker\n* Interested in reducing smoking\n* Not currently enrolled in any smoking cessation program.\n\nExclusion Criteria:\n\n* Not interested in reducing smoking\n* Currently enrolled in a smoking cessation program.'}, 'identificationModule': {'nctId': 'NCT06443294', 'briefTitle': 'Development of a Smoking Cessation Video Series', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Development of a Smoking Cessation Video Series', 'orgStudyIdInfo': {'id': 'IRB-23-10-6207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video Group', 'description': 'Participants randomly assigned to this group will be provided access to the video intervention series.', 'interventionNames': ['Behavioral: Smoking cessation video series.']}, {'type': 'NO_INTERVENTION', 'label': 'No-Video Group'}], 'interventions': [{'name': 'Smoking cessation video series.', 'type': 'BEHAVIORAL', 'description': 'The intervention in this study is a series of six videos totally approximately 40 minutes. These videos are led by a doctoral psychology student with experience in working with tobacco smokers. Videos utilize empirically-supported strategies for smoking cessation.', 'armGroupLabels': ['Video Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael BR Schmidt, MA', 'role': 'CONTACT', 'email': 'schmidtmbr@wayne.edu', 'phone': '734-780-4110'}, {'name': 'Emily Grekin, PhD', 'role': 'CONTACT', 'email': 'grekine@wayne.edu', 'phone': '313-577-2820'}], 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data is not planned to be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Student Researcher', 'investigatorFullName': 'Michael Schmidt', 'investigatorAffiliation': 'Wayne State University'}}}}