Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT04700306
Status:
TERMINATED
Last Update Posted:
2025-06-13
First Post:
2020-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'lack of inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2020-11-27', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)', 'timeFrame': '6 months after the end of consultations', 'description': 'Comparison of the inte craving between the sophrology group and the control group at nsity of 6 months after the end of consultations, using the FTCQ-12 questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Number of cigarettes smoked per day', 'timeFrame': '6 months after the end of consultations', 'description': 'Number of cigarettes smoked per day'}, {'measure': 'Motivation to Quit Smoking by Numerical Scale (0 to 5)', 'timeFrame': '6 months after the end of consultations', 'description': 'Assessment of Motivation to Quit Smoking'}, {'measure': 'Measuring Confidence in Withdrawal Success by numerical scale (0 to 5)', 'timeFrame': '6 months after the end of consultations', 'description': 'Measuring Confidence in Withdrawal Success'}, {'measure': 'Evaluation of sleep by numerical scale (0 to 5)', 'timeFrame': '6 months after the end of consultations', 'description': 'Evaluation of sleep quality'}, {'measure': 'Evaluation of irritability by numerical scale (0 to 5)', 'timeFrame': '6 months after the end of consultations', 'description': 'Evaluation of irritability levels'}, {'measure': 'Fatigue levels by numerical scale (0 to 5)', 'timeFrame': '6 months after the end of consultations', 'description': 'Evaluation of fatigue levels'}, {'measure': 'Fagerström test (0 to 11)', 'timeFrame': '6 months after the end of consultations', 'description': 'Comparison of dependency'}, {'measure': 'CO (carbon monoxide) test', 'timeFrame': '6 months after the end of consultations', 'description': 'Comparison of the evolution of the CO'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sophrology'], 'conditions': ['Craving', 'Cigarette Smoking']}, 'descriptionModule': {'briefSummary': 'To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.', 'detailedDescription': 'Pilot study to evaluate the impact of sophrology on the intensity of craving and on certain determinants of cigarette consumption: number of cigarettes, anxiety, degree of dependence, motivation, confidence, fatigue, irritability, quality of sleep.\n\nThis pilot study could serve as a basis for the development of research on a larger cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First outpatient consultation in tobacco addiction department\n* Consumption greater than or equal to 35 cigarettes per week\n* Minimum age: 18 years old / Maximum age: 75 years old\n* Absence of co-addiction of alcohol, other products and behavioural addictions (except if withdrawal for more than 1 year)\n* Commitment by the patient not to practice hypnosis or mindfulness while participating in the study\n* Mastering reading and writing skills\n* Acceptance to participate in the protocol\n* Affiliated to a social security system\n\nExclusion Criteria:\n\n* Patient-reported psychosis\n* Pregnant women\n* Participation in other intervention research\n* Patient under guardianship or curatorship\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT04700306', 'acronym': 'SOPHCIG', 'briefTitle': 'Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal', 'orgStudyIdInfo': {'id': 'SOPHCIG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sophrology', 'description': 'the patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology', 'interventionNames': ['Behavioral: Sophrology']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'the patient must make 7 visits with interviews and questionnaires'}], 'interventions': [{'name': 'Sophrology', 'type': 'BEHAVIORAL', 'description': 'Patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology.', 'armGroupLabels': ['Sophrology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'CHI Créteil Equipe de liaison et de soins en addictologie (ELSA)', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': "CHU Henri Mondor Service d'addictologie", 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Sylvie Ané', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Intercommunal Créteil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}