Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-08 @ 6:21 AM
Study NCT ID:
NCT03382093
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Feedback for Smokers With Elevated Anxiety Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-18', 'size': 108279, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-12-18T12:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'If participant meets eligibility criteria, the participant will be randomly assigned to complete a computer-delivered intervention: either the (a) Personalized Feedback Intervention or (b) smoking information control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2017-12-18', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate PFI', 'timeFrame': 'Assessed at 1-month follow-up after the one-session intervention', 'description': 'Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.'}], 'secondaryOutcomes': [{'measure': 'Smoking Motivational Processes', 'timeFrame': 'Assessed at 1-month follow-up after the one-session intervention', 'description': 'Smokers in intervention, relative to a smoking information control, will report increased motivation and confidence for quitting smoking. Assessed using Smoking Rulers for Change measure.'}, {'measure': 'Smoking Behavior', 'timeFrame': 'Assessed at 1-month follow-up after the one-session intervention', 'description': 'Smokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide \\[CO\\] analysis.'}, {'measure': 'Affective Processes', 'timeFrame': 'Assessed at 1-month follow-up after the one-session intervention', 'description': 'Smokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure.'}, {'measure': 'Mechanisms', 'timeFrame': 'Assessed at 1-month follow-up after the one-session intervention', 'description': 'Smokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety Sensitivity', 'Tobacco', 'Smoking', 'Anxiety', 'Feedback', 'Stress'], 'conditions': ['Anxiety Disorders', 'Anxiety', 'Tobacco Dependence', 'Smoking, Cigarette', 'Smoking, Tobacco']}, 'descriptionModule': {'briefSummary': 'This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, and adaptive coping strategies.', 'detailedDescription': 'The primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills compared to a smoking information only control. To address this aim, we will implement a randomized controlled trial that will employ a longitudinal experimental design and involve three stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (PFI versus smoking information control with no personalized feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elevated anxiety sensitivity defined as an ASI-III score of at least 17\n* Daily smoking for at least one year (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide \\[CO\\] analysis at least 4 ppm)\n* Not presently engaged in a quit attempt\n* Not currently engaged in mental health treatment\n* Capable of providing informed consent\n* Willing to attend all study visits and comply with the protocol\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners\n* Students for whom you have direct access to/influence on grades\n* Use of other tobacco products\n* Currently suicidal or high suicide risk\n* Currently psychotic or high psychotic risk\n* Insufficient command of English to participate in assessment or treatment'}, 'identificationModule': {'nctId': 'NCT03382093', 'briefTitle': 'Personalized Feedback for Smokers With Elevated Anxiety Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Personalized Feedback for Smokers With Elevated Anxiety Sensitivity', 'orgStudyIdInfo': {'id': 'CR00000267'}, 'secondaryIdInfos': [{'id': '5F31DA043390-02', 'link': 'https://reporter.nih.gov/quickSearch/5F31DA043390-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Personalized Feedback Intervention', 'description': 'A brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills.', 'interventionNames': ['Behavioral: Personalized Feedback Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Smoking Information Control', 'description': 'Standard, computer-delivered smoking cessation treatment/information.', 'interventionNames': ['Behavioral: Smoking Information Control']}], 'interventions': [{'name': 'Personalized Feedback Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['PFI'], 'description': 'Personalized Feedback Intervention for smoking and anxiety.', 'armGroupLabels': ['Personalized Feedback Intervention']}, {'name': 'Smoking Information Control', 'type': 'BEHAVIORAL', 'otherNames': ['Control', 'Clearing the Air Pamphlet'], 'description': 'Smoking Information with no personalized feedback.', 'armGroupLabels': ['Smoking Information Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lorra L. Garey, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}, {'name': 'Michael J. Zvolensky, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychology Doctoral Student', 'investigatorFullName': 'Lorra Garey', 'investigatorAffiliation': 'University of Houston'}}}}