Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence (SHP)
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|ClinicalTrials.gov Identifier: NCT00178685|
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 15, 2013
Last Update Posted : February 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Behavioral: Self-determination Intervention for Tobacco Dependence||Phase 4|
These two studies will extend our examination of self-determination theory (SDT) based counseling interventions to the issue of maintained abstinence from tobacco use. Two projects are proposed, both of which build on the results of our current trial. The first is a 32-month follow-up of the smoking status of patients in the preceding trial called the Smoker's Health Study (self-determination, smoking, diet, and health). That SDT intervention (4 counselor visits over 6 months) increased cessation at 6 months relative to community care, and was also effective in increasing 12 month prolonged abstinence, and the results have been reported in two manuscripts (Williams, McGregor, Sharp, Levesque, Kouides, Ryan, and Deci, In press; Williams, McGregor, Sharp, Levesque, Kouides, Ryan, and Deci, 2005). The part of this first project that will be conducted as part of this grant will be to complete 32 month follow-up of smokers in the Smoker's Health Study. The second project is a 3-cell clinical trial called the Smoker's Health Project that will examine two extensions of the current intervention, both of which place greater emphasis on use of, and adherence to, cessation medications. The two arms will be compared to community care. Both arms involve two visits with a physician to discuss medications and side effects. In both interventions, counselors will address medication adherence. The two arms differ in that patients not ready to quit in one arm will receive a smoking reduction approach (with medications) in which they first try to reduce their smoking to half and then attempt cessation. In addition, to place greater emphasis on medications and to examine medication adherence as a mediator of maintained cessation.
There will be two major changes in the intervention intended to facilitate long-term maintenance. First, the intervention will extend over 12 months (whereas the current one lasts only 6 months) with meetings during the additional 6 months focusing on maintenance and relapse prevention. Second, at least one family member or best friend of each patient will be encouraged to meet with a counselor to learn how to be more autonomy supportive with the patient around issues related to tobacco. Cessation and maintained abstinence will be examined with logistic regression. The SDT process model of maintained cessation will be tested using structural equation modeling, and cost-effectiveness analyses will be done for the interventions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||837 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Self-determination and Maintaining Tobacco Abstinence|
|Study Start Date :||August 2004|
|Primary Completion Date :||August 2008|
|Study Completion Date :||August 2008|
Behavioral: Self-determination Intervention for Tobacco Dependence
- 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. [ Time Frame: 12 months after subject completes intervention. ]The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.
- 7 Day Point Prevelence (7DPP) [ Time Frame: 12 months after the intervention ]Seven-day point prevalence abstinence (7DPP) was assessed by asking: "Have you smoked a cigarette, even a puff, in the last 7 days?"16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178685
|United States, New York|
|Smokers' Health Project|
|Rochester, New York, United States, 14607|
|Principal Investigator:||Geoffrey C Williams, MD, Ph.D.||University of Rochester|