Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence

NCT ID: NCT00178685

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 837 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2008-08-31

Brief Summary

These two studies will examine the role of autonomous motivation in maintained adherence. The first study will determine whether smokers are still abstinent from tobacco 32 months after starting in a previous project (Smoker's Health Study). The purpose of the second study is to determine which of three treatments for tobacco dependence provides the greatest amount of protection from relapsing to smoking after quitting. Specifically, the investigators will determine if extending the length of treatment time focusing on relapse prevention and arranging for support from important others prevents relapse compared to community care. Also, the investigators will determine if providing extended treatment time and support from important others plus providing medications to those that don't want to quit prevents long term relapse compared to just extending the length of treatment time and support from others. Additionally, a sub set of the population will be randomized to using hand held palm devices to recover real-time data assessment during the last 10 months of the project.

Detailed Description

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Self-determination Intervention for Tobacco Dependence

autonomy supported behavioral intervention for tobacco dependent individuals

Intervention Type: BEHAVIORAL

Other Intervention Names

Smokers' Health Project

Eligibility Criteria

Inclusion Criteria

• Smoking 5 or more cigarettes per day.
• 18 years of age or older.
• Speak and read English.
• Eligible regardless of desire to quit smoking

Exclusion Criteria

• Pregnancy
• History of psychotic illness other than depression
• Life expectancy of less than 24 months
• Dementia, or incompetence for medical decision making

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

New York State Department of Health

OTHER_GOV

Sponsor Role: collaborator

Greater Rochester Area Tobacco Cessation Center

UNKNOWN

Sponsor Role: collaborator

Health Maintenance Consortium

UNKNOWN

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

University of Rochester, Smokers' Health Project

Principal Investigators

Geoffrey C Williams, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Smokers' Health Project

Rochester, New York, United States

Countries

United States

References

Williams GC, McGregor HA, Sharp D, Levesque C, Kouides RW, Ryan RM, Deci EL. Testing a self-determination theory intervention for motivating tobacco cessation: supporting autonomy and competence in a clinical trial. Health Psychol. 2006 Jan;25(1):91-101. doi: 10.1037/0278-6133.25.1.91.

Reference Type: BACKGROUND

PMID: 16448302 (View on PubMed)

Williams GC, McGregor H, Sharp D, Kouldes RW, Levesque CS, Ryan RM, Deci EL. A self-determination multiple risk intervention trial to improve smokers' health. J Gen Intern Med. 2006 Dec;21(12):1288-94. doi: 10.1111/j.1525-1497.2006.00621.x.

Reference Type: BACKGROUND

PMID: 16995893 (View on PubMed)

Williams GC, Minicucci DS, Kouides RW, Levesque CS, Chirkov VI, Ryan RM, Deci EL. Self-determination, smoking, diet and health. Health Educ Res. 2002 Oct;17(5):512-21. doi: 10.1093/her/17.5.512.

Reference Type: BACKGROUND

PMID: 12408196 (View on PubMed)

Niemiec CP, Ivarsson A, Weman K, Smit E, Williams GC. Self-determination theory and the smoking cessation process: Daily electronic self-reports can identify the initiation of quit attempts. Patient Educ Couns. 2023 Oct;115:107886. doi: 10.1016/j.pec.2023.107886. Epub 2023 Jul 7.

Reference Type: DERIVED

PMID: 37567038 (View on PubMed)

Williams GC, Niemiec CP, Patrick H, Ryan RM, Deci EL. Outcomes of the Smoker's Health Project: a pragmatic comparative effectiveness trial of tobacco-dependence interventions based on self-determination theory. Health Educ Res. 2016 Dec;31(6):749-759. doi: 10.1093/her/cyw046. Epub 2016 Oct 22.

Reference Type: DERIVED

PMID: 27923864 (View on PubMed)

Ternullo SR, Abdolahi A, Williams GC. Study of monotherapy versus combination therapy for tobacco dependence among heavily addicted smokers. J Am Pharm Assoc (2003). 2017 Jan-Feb;57(1):77-81.e1. doi: 10.1016/j.japh.2016.08.011. Epub 2016 Nov 11.

Reference Type: DERIVED

PMID: 27839954 (View on PubMed)

Pesis-Katz I, Williams GC, Niemiec CP, Fiscella K. Cost-effectiveness of intensive tobacco dependence intervention based on self-determination theory. Am J Manag Care. 2011 Oct 1;17(10):e393-8.

Reference Type: DERIVED

PMID: 21999719 (View on PubMed)

Williams GC, Patrick H, Niemiec CP, Ryan RM, Deci EL, Lavigne HM. The smoker's health project: a self-determination theory intervention to facilitate maintenance of tobacco abstinence. Contemp Clin Trials. 2011 Jul;32(4):535-43. doi: 10.1016/j.cct.2011.03.002. Epub 2011 Mar 5.

Reference Type: DERIVED

PMID: 21382516 (View on PubMed)

Williams GC, Niemiec CP, Patrick H, Ryan RM, Deci EL. The importance of supporting autonomy and perceived competence in facilitating long-term tobacco abstinence. Ann Behav Med. 2009 Jun;37(3):315-24. doi: 10.1007/s12160-009-9090-y. Epub 2009 Apr 17.

Reference Type: DERIVED

PMID: 19373517 (View on PubMed)

Niemiec CP, Ryan RM, Deci EL, Williams GC. Aspiring to physical health: the role of aspirations for physical health in facilitating long-term tobacco abstinence. Patient Educ Couns. 2009 Feb;74(2):250-7. doi: 10.1016/j.pec.2008.08.015. Epub 2008 Oct 5.

Reference Type: DERIVED

PMID: 18838243 (View on PubMed)

Related Links

http://www.selfdeterminationtheory.org

Related Info

Other Identifiers

R01 CA10666

Identifier Type: -

Identifier Source: secondary_id

1R21CA119112-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10085

Identifier Type: -

Identifier Source: org_study_id