Group Counseling for Smoking Cessation
| Tracking Information | |||||
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| First Received Date ICMJE | March 1, 2005 | ||||
| Last Updated Date | December 7, 2011 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
cigarette smoking abstinence | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00104481 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Group Counseling for Smoking Cessation | ||||
| Official Title ICMJE | Cognitive Behavior Therapy for Smoking Cessation | ||||
| Brief Summary | The purpose of this study is to evaluate the effectiveness of group therapy for cigarette smoking cessation. The group meets for 8 sessions and includes education and group discussion about the effects of smoking and ways to cope with withdrawal symptoms and other challenges to maintaining abstinence. In one condition, the groups also learn techniques based on cognitive therapy, to help cope with negative feelings. |
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| Detailed Description | The comparison condition is the same length as the cognitive behavior therapy condition but omits the cognitive restructuring component. In both conditions, smokers prepare for a quit date by using scheduled reduced smoking, which involves smoking on a set schedule that gradually reduces the number of cigarettes smoked. Post-treatment assessments occur one week after the end of treatment, and at 3-month followup. Pre- and post-treatment assessments include measures of coping skills and emotional acceptance, as well as smoking rate. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Smoking | ||||
| Intervention ICMJE | Behavioral: cognitive behavior therapy | ||||
| Study Arm (s) | |||||
| Publications * | Haaga DA, Thorndike FP, Friedman-Wheeler DG, Pearlman MY, Wernicke RA. Cognitive coping skills and depression vulnerability among cigarette smokers. Addict Behav. 2004 Aug;29(6):1109-22. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 240 | ||||
| Completion Date | August 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00104481 | ||||
| Other Study ID Numbers ICMJE | 2R15CA077732-02A1, 2R15CA077732-02A1 | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | |||||
| Study Sponsor ICMJE | American University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | American University | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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