Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT01080092
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2010-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-01', 'studyFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Craving at the end of each of two (learning) sessions;', 'timeFrame': '1 day', 'description': "Measurement by means of participant's estimation of feelings of smoking urge and smoking craving (by means of the Minnesota Nicotine Withdrawal Scale) before and immeadiately after each of two intervention sessions)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smokers'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'website of University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Craving is one of the most prominent reasons for relapse after smoking cessation. Mainly pharmacological aids (NRT, bupropion, varenicline) try to counter this condition. This project aims to evaluate the effect of stress-management and a short breathing technique, reinforced by means of visualisation , on the experience of craving in smokers who are prepared to stay abstinent for at least 3 hours before the start of the intervention. It is expected that this strategy can provide supplementary gains in craving control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smokers (at least 10 cigarettes/day);\n* 18 years of age or older;\n* prepared to stay abstinent for 3 hours before the start of the session;\n* not prepared to stop smoking;\n* Dutch speaking.\n\nExclusion Criteria:\n\n* acute health related problems;\n* psychiatric co-morbidities;\n* quit attempts in the past 3 months;\n* participation in other clinical trials.'}, 'identificationModule': {'nctId': 'NCT01080092', 'briefTitle': 'Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study', 'orgStudyIdInfo': {'id': '2010/020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'breathing technique group', 'description': 'technique as a stress management technique, reinforced by biofeedback', 'interventionNames': ['Behavioral: breathing technique']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'no breathing technique', 'description': 'the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving', 'interventionNames': ['Behavioral: behavioral strategies']}], 'interventions': [{'name': 'breathing technique', 'type': 'BEHAVIORAL', 'description': 'breathing technique as a stress management technique, reinforced by biofeedback', 'armGroupLabels': ['breathing technique group']}, {'name': 'behavioral strategies', 'type': 'BEHAVIORAL', 'description': 'the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving', 'armGroupLabels': ['no breathing technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Hedwig Boudrez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}