Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT00639093
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2008-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Virtual Arm to Stop Smoking
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'g.r.a.p@videotron.ca', 'phone': '418-542-2030', 'title': 'Benoît Girard', 'organization': 'GRAP, Clinique de Psychologie au Travail'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'VR - Cigarettes', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VR - Balls (Control)', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).', 'otherNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VR - Cigarettes', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).'}, {'id': 'OG001', 'title': 'VR - Balls (Control)', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 4, 6, 12, 24 and 12-month follow-up', 'description': 'Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample.\n\nSix measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Tiffany's Urge to Smoke Questionnaire", 'timeFrame': 'Weeks 1, 4, 6, 12, 24 and 12-month follow-up', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VR - Cigarettes', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).'}, {'id': 'FG001', 'title': 'VR - Balls (Control)', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '45', 'groupId': 'FG000', 'numSubjects': '45'}, {'comment': '46', 'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '45', 'groupId': 'FG000', 'numSubjects': '45'}, {'comment': '46', 'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Medical clinic in the province of Quebec.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VR - Cigarettes', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).'}, {'id': 'BG001', 'title': 'VR - Balls (Control)', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Aged above 18.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Nicotine addiction', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'As stated in the Eligibility Criteria, participants had to be smokers (10 cigarettes per day minimum) wanting but incapable to quit.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2008-03-12', 'resultsFirstSubmitDate': '2009-07-30', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-30', 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.', 'timeFrame': 'Weeks 1, 4, 6, 12, 24 and 12-month follow-up', 'description': 'Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample.\n\nSix measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up).'}], 'secondaryOutcomes': [{'measure': "Tiffany's Urge to Smoke Questionnaire", 'timeFrame': 'Weeks 1, 4, 6, 12, 24 and 12-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cigarette smoking', 'psychoeducational and motivational program', 'virtual reality'], 'conditions': ['Cigarette Smoking']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Girard, B., & Turcotte, V. (2007). A virtual arm to stop smoking, a perceptual learning experiment. In N. Appel & H. Hoffman (Chairs), Addictions. Symposium presented at the Cybertherapy 12 Conference, in June in Washington, D.C.'}, {'pmid': '16314049', 'type': 'BACKGROUND', 'citation': 'Martin RA, Rohsenow DJ, MacKinnon SV, Abrams DB, Monti PM. Correlates of motivation to quit smoking among alcohol dependent patients in residential treatment. Drug Alcohol Depend. 2006 Jun 9;83(1):73-8. doi: 10.1016/j.drugalcdep.2005.10.013. Epub 2005 Nov 28.'}, {'pmid': '19817561', 'type': 'DERIVED', 'citation': 'Girard B, Turcotte V, Bouchard S, Girard B. Crushing virtual cigarettes reduces tobacco addiction and treatment discontinuation. Cyberpsychol Behav. 2009 Oct;12(5):477-83. doi: 10.1089/cpb.2009.0118.'}], 'seeAlsoLinks': [{'url': 'http://www.grap.ca/', 'label': 'Click here for more information about this study about the virtual arm'}, {'url': 'http://w3.uqo.ca/cyberpsy', 'label': 'Click here for more information about clinical applications of virtual reality'}, {'url': 'http://www.virtuallybetter.com/', 'label': 'For more information about using VR to treat smoking'}]}, 'descriptionModule': {'briefSummary': "The investigators reported in a pilot study presented at last year's Cybertherapy Conference (Girard \\& Turcotte, 2007) that using an action-cue exposure strategy in virtual reality (ACE-VR; crushing virtual cigarettes) might be useful in the treatment of tobacco addiction.\n\nThe investigators are pursuing research in this area with a randomized control trial based on 90 smokers who will receive a brief psychosocial smoking cessation program (25 people are enrolled so far and we expect to finish the study before the conference). During the first four weeks of an eight-session psychoeducational and motivational program, all participants will be immersed in VR. During the immersions in VR, 45 of the participants will use a virtual arm to catch and crush virtual cigarettes. The other half of the sample will use the virtual arm to catch virtual fruits (control condition).\n\nThe smoking frequency, and abstinence, will be assessed with a daily diary and exhaled carbon monoxide tests (the CO2 tests will provide an objective confirmation of the abstinence reported in the diaries). The success the program will be compared based on the number of subjects who quitted or reduced their smoking frequency. The severity of addiction will be assessed with two questionnaires, the Fagerstrom and the Horn tests. Craving and withdrawal effects will be measured with the Minnesota Nicotine Withdrawal Scale (MNWS) and the Brief Questionnaire of Smoking Urges (QSU-Brief) at the baseline and at the visits from weeks 1 through 4, 6, 12 and at the end of the program. Before the VR immersion, the Immersive Tendencies Questionnaire will be administered and after each VR session participants will fill two questionnaires addressing presence and cybersickness. The comparative impact of both treatments will be tested with repeated measures ANOVAs (and planned contrasts) with sufficient power to detect medium effect sizes.\n\nThe main goal of our study is show that crushing virtual cigarettes can boost the impact of a behavioural program dedicated to cigarette addiction.", 'detailedDescription': 'A detailed description is available, in French, by contacting stephane.bouchard@uqo.ca.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult smoker\n* aged 18 - 65\n* willing to stop smoking\n* at least 10 cigarettes per day in the last year\n\nExclusion Criteria:\n\n* receiving concomitant treatment for smoking (e.g., patches or varenicline)\n* weight problems : Body Mass Index \\< 15 kg or \\> 45.5 kg\n* suffering from a mental disorder, such as major depression, schizophrenia, etc.'}, 'identificationModule': {'nctId': 'NCT00639093', 'briefTitle': 'A Virtual Arm to Stop Smoking', 'organization': {'class': 'OTHER', 'fullName': 'Universite du Quebec en Outaouais'}, 'officialTitle': 'A Virtual Arm to Stop Smoking. A Comparative Study', 'orgStudyIdInfo': {'id': 'GRAP-CRC-cyberpsychologie'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).', 'interventionNames': ['Behavioral: psychoeducational / motivational combined with crushing']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).', 'interventionNames': ['Behavioral: psychoeducational / motivational combined with control']}], 'interventions': [{'name': 'psychoeducational / motivational combined with crushing', 'type': 'BEHAVIORAL', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).', 'armGroupLabels': ['1']}, {'name': 'psychoeducational / motivational combined with control', 'type': 'BEHAVIORAL', 'description': 'All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).\n\nDuring the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G7X 0A4', 'city': 'Jonquière', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GRAP - Clinique de psychologie au travail', 'geoPoint': {'lat': 48.41648, 'lon': -71.24884}}], 'overallOfficials': [{'name': 'Benoit Girard, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'G.R.A.P.'}, {'name': 'Stephane Bouchard, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'U.Q.O.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universite du Quebec en Outaouais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stephane Bouchard', 'investigatorAffiliation': 'Universite du Quebec en Outaouais'}}}}