Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT01633632
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2012-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hatha Yoga for Smoking Cessation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2012-07-02', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Point prevalence abstinence from smoking', 'timeFrame': 'End of intervention (week 7)', 'description': 'Abstinence from smoking as measured by expired carbon monoxide at the end of the 7-week intervention.'}], 'secondaryOutcomes': [{'measure': 'Abstinence from smoking', 'timeFrame': '3 and 6 months', 'description': 'Prolonged abstinence defined as no smoking after the identified "quit date" and point prevalence abstinence (no smoking in the past 7 days) will be measured. Measured by self-report.'}, {'measure': 'Change in weight', 'timeFrame': 'End of intervention (week 7)', 'description': 'Change in weight from baseline to week 7'}, {'measure': 'Signs and symptoms of nicotine withdrawal', 'timeFrame': 'Weeks 1-7 during intervention period', 'description': 'Survey will be administered weekly during class sessions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Yoga', 'Cognitive behavioral therapy'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Burns TL, Mayer AE, Washington-Krauth SM, Walters RW, Arouni AJ. Design and Feasibility of a Hatha Yoga Intervention for Smoking Cessation. Journal of Smoking Cessation 2014; doi:10.1017/jsc.2014.21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt.', 'detailedDescription': 'While many smoking cessation interventions have been studied, even the most successful interventions result in less than 40% abstinence from smoking at 6 months. Most people attempt to quit multiple times before maintaining long-term abstinence from tobacco. Research into interventions to improve quit rates and decrease smoking prevalence is a high priority for multiple organizations. Yoga is an attractive non-pharmacological option because it can be used safely during pregnancy and lactation, can be combined with other pharmacologic and non-pharmacologic treatments, and can be continued well past the smoking cessation date to combat withdrawal symptoms and cravings. There is a critical need for innovative and effective methods for tobacco control that focus on both prevention and cessation.\n\nThis project will be broken into two stages. The first stage will aim to pilot test yoga techniques for feasibility and acceptability. Recruitment and retention strategies will be tested and participant satisfaction will be evaluated. Preliminary measures of smoking abstinence and withdrawal symptoms will be conducted.\n\nThe second stage of this study will be a randomized trial to compare smoking abstinence with cognitive behavioral therapy (CBT), CBT + yoga, or yoga alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 years or older\n* Smoker of 5 or more cigarettes per day\n* Willing and physically able to participate in yoga\n* Not currently practicing Hatha yoga.\n\nExclusion Criteria:\n\n* Use of smokeless tobacco'}, 'identificationModule': {'nctId': 'NCT01633632', 'briefTitle': 'Hatha Yoga for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation', 'orgStudyIdInfo': {'id': '12-16438/13-16721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive behavioral therapy', 'description': 'This group will receive a standardized, 8-session cognitive behavioral therapy course that is offered to the public at our practice.', 'interventionNames': ['Behavioral: Cognitive behavioral therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive behavioral therapy + yoga', 'description': 'This group will receive the standardized, 8-session cognitive behavioral therapy course + 8 sessions of Hatha yoga.', 'interventionNames': ['Behavioral: Hatha yoga', 'Behavioral: Cognitive behavioral therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Hatha yoga', 'description': 'This group will receive 8 sessions of Hatha yoga and printed materials to assist with their quit attempt', 'interventionNames': ['Behavioral: Hatha yoga']}], 'interventions': [{'name': 'Hatha yoga', 'type': 'BEHAVIORAL', 'description': '30 minutes of instruction in Hatha yoga will be provided for 8 sessions.', 'armGroupLabels': ['Cognitive behavioral therapy + yoga', 'Hatha yoga']}, {'name': 'Cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'description': '8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.', 'armGroupLabels': ['Cognitive behavioral therapy', 'Cognitive behavioral therapy + yoga']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68178', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Amy Mayer, OTD, OTR/L', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}