A previous randomized clinical trial based on self-determination theory (SDT) and consistent with the Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence demonstrated that an intensive intervention could change autonomous self-regulation and perceived competence, which in part facilitated long-term tobacco abstinence. The current article describes a pragmatic comparative effectiveness trial of three SDT-based intensive tobacco-dependence interventions. Eligible participants are randomized to one of the three treatment conditions designed to facilitate long-term maintenance of tobacco abstinence, namely, Community Care (CC), which includes the 6. month SDT-based intervention previously shown to promote autonomous self-regulation, perceived competence, medication use, and tobacco abstinence; Extended Need Support (ENS), which extends the 6. month SDT-based intervention to 12. months and trains an important other to provide support for smokers' basic psychological needs; and Harm Reduction (HR), which provides extended need support and recommends medication use for participants who do not want to stop smoking completely within 30. days but who are willing to reduce their cigarette use by half. The primary outcome is 12. month prolonged abstinence from tobacco, which is assessed one year following termination of treatment (two years post-randomization). Secondary outcomes include 7- and 30. day point prevalence tobacco abstinence, number of days using smoking-cessation medication, change in autonomous self-regulation and perceived competence, and perceived need support from important others.
Bibliographical noteFunding Information:
This research was supported by grants from the National Cancer Institute [ R01-CA106668 ] awarded to Dr. Geoffrey Williams, MD, PhD; the National Institute of Mental Health and the National Cancer Institute [ R01-MH059594 ] awarded to Dr. Geoffrey Williams, MD, PhD; the National Center for Research Resources [ M01-RR00044 ] awarded to the University of Rochester General Clinical Research Center; and the National Center for Research Resources ARRA Supplement [ UL1RR024160 ] awarded to the University of Rochester's Clinical and Translational Science Institute.
- Perceived competence
- Pragmatic comparative effectiveness trial
- Self-determination theory
- Tobacco abstinence