This application (RFA # OB-03-003) extends 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 32month follow-up of the smoking status of patients in the current trial. The SDT intervention was effective at 6 months relative to community care, and, according to preliminary analyses, was also effective for maintenance at 18 months, but long-term (32-month) follow-up data are needed. The second project is a 3-cell clinical trial. The current results show that patients were four times more likely to quit by 6 months if they used medications known to be efficacious for cessation, so the trial 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 greater emphasis on medications and examination of 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 time 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. Our current results show that family autonomy support predicts cessation, and family members represent an important source of support for long-term maintenance of abstinence. Cessation and maintained abstinence will be examined with logistic regression and survival curve analyses. The SDT process model of maintained cessation will be tested using structural equation modeling, and cost-effectiveness analyses will be done for the interventions.
Considerable research shows theory-based biopsychosocial interventions to be effective in promoting change of health-related behaviors such as tobacco use and lack of exercise. As noted in the RFA Maintenance of Long Term Behavioral Change, however, maintenance of those changes has not been well studied. We were awarded a grant from the 1997 RFA, "Innovative Approaches to Disease Prevention through Behavior Change," and the present proposal builds on results from that project. A central component of that current project applies self-determination theory (SDT) to treatment of tobacco dependence. The project is a cessation-induction trial, so it includes all smokers willing to participate in the study rather than just those ready to quit (Hughes et al, in press). Our aim was to promote cessation among the broader population of tobacco users rather than just the ones already motivated to quit. In the current project, we found the SDT-based intervention was effective for promoting smoking cessation at the end of the 6-month treatment period for the intervention group relative to the group that got standard community care (18.9% vs. 8.0%; odds ratio = 2.4). Further, there is evidence from 18-month follow-up data that the intervention (relative to community care) yields significantly greater maintenance (13.5% vs.
6.4%; odds ratio = 2.1) and continuous abstinence (7.5% vs. 2.6%; odds ratio = 2.9). The first project of the proposed research will examine long-term maintenance by assessing smoking status of the patients from this trial at 32 months, which given the findings, seems very important.
Of the participants in the current study, 54% said at their initial meeting that they were not ready to try quitting. Even for these patients, there was a significant difference in 6-month quit rates for intervention patients relative to community-care patients (16.4% vs. 6.2%; odds ratio = 2.6). Thus, the intervention promoted cessation for these patients as well as for patients who were ready to quit. This finding encourages us to continue working with all smokers in order to find more effective ways to promote maintained cessation, so the second project of the proposed research will also be a cessation-induction trial to extend and improve our current intervention.
In the current trial a significantly greater percentage of patients used efficacious cessation medications in the intervention group than in the community-care group (36.8% vs. 18.4%). As well, across conditions, cessation rates were significantly higher for patients who used medication than for patients who did not (33.3% vs. 7.6%; odds ratio = 4.4). These results prompt us to examine medication use more centrally in the proposed trial. Further, in the current trial, the intervention significantly increased patients' autonomous motivation to adhere to medication regimens, and autonomous motivation for medication adherence was a significant predictor of cessation. However, we did not examine medication adherence per se. In the proposed trial we will study actual adherence as one pathway to maintained cessation. Greater use of medications should increase the quit rate during treatment, which should in turn lead to greater maintained abstinence. However, to specifically promote maintenance over the long-term, the proposed trial will (1) increase the treatment period to 12 months to have more time to deal with relapse prevention especially when patients encounter stress or are experiencing cessation fatigue (Piasecki et al., 2002), and (2) involve families/friends as long-term supports.
The SDT process model of health behavior change (Williams et al., 2002) proposes that autonomy-supportive interventions and providers will promote greater autonomous motivation and perceived competence for cessation. Further, autonomy support from family members is also expected to enhance these motivation variables. The motivation variables in turn are expected to promote actual cessation. The current trial provided support for every one of these predictions, and the process model fit the data very well, explaining both between-group differences and within-group variability in outcomes. With the results mentioned above, it is now important to include autonomous motivation and perceived competence for medication adherence as well as actual adherence into the process model. Further, in the proposed trial, the primary outcome will be maintenance of change rather than the initial change studied in the current trial. Although not hypothesized in our current study, we found highly significant interactions indicating increased vitality and decreased dysphoric mood from baseline to 6 months for patients who quit smoking, but decreased vitality and increased dysphoric mood for patients who did not quit. This highlights the importance of further examining quality of life during maintenance.
In the proposed trial, patients will be randomly assigned to community care (Condition 1) or to one of the two intervention arms. Each intervention is an extension of the intervention shown to be effective for maintained cessation in the current trial. In Condition 2 all patients will consult a physician who, in line with standard practice, will recommend cessation medication only to patients ready to quit, if it is not contraindicated. Further, counselors will address medication adherence as an aspect of the intervention; they will address relapse more vigorously; and they will train a family member or friend to be more autonomy supportive if the patient agrees. In Condition 3, in addition to recommending medications to patients ready to quit, a smoking-reduction approach, with the aid of medications, will be used for patients who are not ready to quit or who relapsed and are not ready to try again. For these patients, we will begin by working to reduce the number of cigarettes to half and when that is accomplished, cessation will be considered. In this group, counselors will also address adherence, relapse prevention, and the support of a family member or friend. In all three conditions we will examine medication adherence as a mediator of treatment effects on maintained cessation, an issue that has received little empirical attention in tobacco-dependence treatment yet is of central importance in determining the effectiveness of the medications (Pierce & Gilpin, 2002). The proposed trial will have a 24-month follow up. The focus on medication use and adherence will require additional physician time with each patient in the proposed interventions (relative to the intervention in our current trial), so we will do cost effectiveness analyses for the two expanded interventions relative to community care and to the intervention in the current trial.
In sum, the specific aims of the proposed work are: