© 2006 American Public Health Association DOI: 10.2105/AJPH.2005.080382
Sharon M. Hall, Janice Y. Tsoh, Judith J. Prochaska, Stuart Eisendrath, Gary L. Humfleet, and Julie A. Gorecki are with the University of California, San Francisco. Joseph S. Rossi and Colleen A. Redding are with the University of Rhode Island Cancer Prevention Research Center, Kingston, RI. Marc Meisner is with Kaiser Permanente, San Rafael, Calif. At the time of this study, Amy B. Rosen was with the University of California, San Francisco. Correspondence: Requests for reprints should be sent to Sharon M. Hall, PhD, University of California, San Francisco, Treatment Research Center, 401 Parnassus Avenue, Box 0984, San Francisco, CA, 94143 (e-mail: shall{at}lppi.ucsf.edu).
Objectives. Using a brief contact control, we tested the efficacy of a staged care intervention to reduce cigarette smoking among psychiatric patients in outpatient treatment for depression.
Methods. We conducted a randomized clinical trial that included assessments at baseline and at months 3, 6, 12, and 18. Three hundred twenty-two patients in mental health outpatient treatment who were diagnosed with depression and smoked Results. As we hypothesized, abstinence rates among staged care intervention participants exceeded those of brief contact control participants at months 12 and 18. Significant differences favoring staged care intervention also were found in occurrence of a quit attempt and stringency of abstinence goal. Conclusion. The data suggest that individuals in psychiatric treatment for depression can be aided in quitting smoking through use of staged care interventions and that smoking cessation interventions used in the general population can be implemented in psychiatric outpatient settings.
The mental health system has been reluctant to identify and treat tobacco dependence despite exhortations to diagnose and treat this often fatal disorder.1,2 This phenomenon can be linked to the belief on the part of mental health professionals that they do not have the skills to provide smoking treatment, the failure to understand that mental health patients can succeed in quitting smoking, reimbursement concerns, and fear of exacerbation of symptoms during nicotine withdrawal. 2,3 Also, it is sometimes assumed that individuals with mental illness are too distracted, demoralized, or disorganized to benefit from smoking treatment. One large-scale recent study estimated that 44.3% of the cigarettes smoked in this country are smoked by individuals with a psychiatric disorder, such as substance abuse and dependence, schizophrenia, bipolar disorder, and major depressive disorder (MDD).4 Depressed smokers may be numerically the largest group of comorbid smokers, because of considerable co-occurrence, as well as the high incidence and prevalence of depression.5 There are compelling arguments for the provision of smoking treatment in the psychiatric outpatient setting. The first such argument is the high prevalence of cigarette smoking in that setting.6,7 Second, if smoking cessation exacerbates psychiatric disorders, quitting smoking while in treatment would provide a safety net.3 Third, although mental health providers may view themselves as unable to skillfully provide nicotine-dependence treatment, they already possess the basic tools needed to provide such treatment, including interviewing and behavior change methods and knowledge of psychopharmacology. The Agency for Health Care Policy and Research guidelines8 and the American Psychiatric Association practice guidelines9 available at the time this study was initiated (in 1999) suggested that smokers with comorbid mental health conditions should be offered the same smoking cessation treatments that have been identified as effective for smokers in general: skill training, pharmacotherapy, and clinical support. It is important to note that these recommendations are not currently implemented in mental health treatment settings.1 The clinical trial described in our article tested the efficacy of a staged care intervention that was implemented in the mental health outpatient setting and was designed to change smoking behavior in all smokers, including those unmotivated to quit. The target population of interest was patients in outpatient treatment for depression. The staged care intervention was an appropriate intervention for smokers enrolled in depression treatment, because smoking cessation would not be a primary goal for these individuals. Yet, their presence in the mental health treatment setting provided an opportunity to intervene in their smoking behavior. The staged care intervention operationalized the recommendations of the Agency for Health Care Policy and Research and the American Psychiatric Association practice guidelines.8,9 It integrated a computerized feedback system that was based on the Transtheoretical Model, which provided feedback about smoking with a provision for face-to-face individual psychological counseling and pharmacological treatment at the appropriate stage of readiness.10 The staged care intervention was compared with an educational materials and referral list control (brief contact control). The control condition was designed to model current practices in mental health clinics, although in practice it probably exceeded those usually provided. We proposed 4 hypotheses: (1) staged care intervention participants will be more likely to be abstinent from cigarettes at months 12 and 18 than participants in the brief contact control group. Observed effect sizes on interventions with smokers who may not be ready to quit smoking have been observed in the literature,11,12 and, in light of these findings we did not expect significant differences in abstinence rates at months 3 and 6. (2) Staged care intervention participants will be more likely to report at least 1 attempt at quitting smoking than brief contact control participants at months 3, 6, 12, and 18. (3) At months 3, 6, 12, and 18, staged care intervention participants will have more stringent smoking abstinence goals than brief contact control participants. (4) Independent of treatment condition, less severe depressive symptoms measured at baseline with the Beck Depression Index (BDI-II) will predict abstinence from cigarettes at months 3, 6, 12, and 18.13
Sites We conducted our trial at 4 mental health outpatient clinics from April 2000 through June 2003. The first site was a university-based, training-focused clinic (n = 103), and the other 3 were part of a large health maintenance organization (HMO; n = 219). All were located in an urban area and provided a range of services, including group and individual psychotherapy and pharmacotherapy.
Participants
Patients who met the screening criteria during a telephone interview that included the PRIME-MD were invited to an orientation meeting in which project staff described the study. Participants also provided baseline data, including psychometric instruments. As shown in Figure 1
The randomization allocation list was computer generated by statistical staff. On the basis of this list and after completing the baseline assessment, interviewers randomly assigned participants to conditions from within stratified blocks, according to the number of cigarettes smoked per day and the participants stage of change.
Staged Care Intervention Model Components The computerized system used in the present study is described in detail elsewhere.15 Participants met with their counselor and responded to questions on the computer about their cognitive and behavioral processes of change, their perceptions of the pros and cons of smoking, and about temptations to smoke. The system made normative and ipsative comparisons and produced a report that was designed to optimize movement into the next stage. The report described the participants current stage, how their decisions and cognitive and behavioral processes compared with those of others and to their own earlier reports, and tempting situations and strategies for movement to the next stage of readiness. It also provided an individualized report of tempting situations and proposed strategies for moving to the next stage of readiness. The counselor and the participant reviewed the written report together. Treatment sessions based on the computerized feedback reports lasted about 15 minutes. They were held at baseline, and at months 3, 6, and 12. Cessation treatment program. The second component of the staged care intervention model was a cessation treatment program for participants who had reached at least the contemplation stage on the basis of their computerized feedback report. The cessation treatment consisted of psychological counseling adapted from published interventions,16,17 nicotine patches, and possible use of sustained-release bupropion. Upon entrance into the study, each participant was assigned 1 of 2 counselorsone with a masters degree in psychology and a second with a doctorate in clinical psychology. Counselors provided the motivational counseling and cessation treatment to willing participants and were supervised weekly by either the project coordinator or by the first author. When participants reached the contemplation stage, they were offered cessation treatment. But, because of ethical concerns, any participant who requested cessation treatment, regardless of their stage, received it. During the study period, 34% (n= 53) of the staged care intervention participants entered cessation treatment.19 Counseling was provided in 6 sessions of 30 minutes each, over the course of 8 weeks and focused on immediate and complete cessation at the agreed-upon quit date. The intervention included development of a commitment to abstinence and a quit plan that was iteratively revised during the quitting process, selection of a quit date, participation in a series of self-tests pertaining to reasons for smoking, discussion of information about the risks of smoking and the benefits of quitting, and discussion of information on nutrition and exercise. The intervention also included mood monitoring, discussions of ways to increase pleasant moods and decrease negative ones, use of behavioral skills to reduce relapse risk, and relaxation and social support skills. A manual is available from the senior author upon request. Participants who smoked 10 or more cigarettes per day received 21-mg nicotine patches for the first 6 weeks, 14-mg patches for weeks 7 and 8, and 7-mg patches for the final 2 weeks. Participants who smoked fewer than 10 cigarettes per day started with 14-mg patches for 6 weeks and switched to 7-mg patches for the remainder of treatment. If a patient failed to quit smoking using nicotine replacement therapy or resumed smoking at any time after initiating cessation treatment, he or she was eligible to request bupropion from the project staff. Requests were relayed to the patients mental health provider by project staff, and an agreement was reached about the appropriateness of bupropion for the participant.
Brief Contact Control Intervention
Measures Questionnaire, interview, and information-system data. Commitment to abstinence was measured by the Thoughts about Abstinence Questionnaire,20,21 which assesses endorsement to 1 of 6 categories of abstinence goal and indicates varying degrees of commitment to complete abstinence: (1) quit forever, (2) quit but might slip, (3) occasional use, (4) abstinence for a time, (5) controlled use, (6) no clear goal. Responses are robust predictors of abstinence during and after tobacco dependence and substance abuse treatment.20,22 The questionnaire was administered at all assessments. Other instruments. The remaining instruments have been widely used in both psychiatric and nonpsychiatric populations. The Stages of Change questions were administered to all participants in both experimental and control conditions.18 Depressive symptoms were measured by the total score of the BDI-II.13 Level of nicotine dependence was assessed with the Fagerström Test for Nicotine Dependence (FTND).23 These instruments were administered at all assessments, but FTND analyses were restricted to baseline assessments in this study. The depression/ dysthymia, mania/hypomania, and nicotine dependence sections of the computerized Diagnostic Interview Schedule24 and the FTND23 were administered at baseline.
Assessments
Data Analysis Methods
Before testing our hypotheses, we compared the treatment conditions on baseline variables and computed propensity scores to predict assessment attrition. These dichotomous scores were based on completion of all assessments versus noncompletion of all assessments.25,26 Propensity scores estimate the effect of missing data on outcomes. A nonsignificant contribution suggests that missing data patterns probably did not bias results and that the score can be eliminated from the final model; a significant score indicates that the missing data patterns may have affected results and should be retained in the model to correct for that contribution.27 If the score did not contribute significantly to the model at P
In testing the hypotheses, the prototypical model was a generalized estimation equation (GEE). Baseline variables in Tables 1
In order to increase generalizability to clinically recognized diagnostic categories, we replicated the tests of the 4 hypotheses including only smokers with a diagnosis of major depressive disorder (n = 307). We used 2 to compare enrollees versus nonenrollees in the cessation treatment of the staged care intervention on attainment of abstinence at any assessment.
Descriptive Statistics Participant recruiting and follow-up rates are shown in Figure 1
Hypothesis Tests
The GEE assessing the second hypothesis, that staged care intervention participants would be more likely to report a quit attempt than brief contact control participants, indicated a significant treatment by cigarettes smoked at baseline interaction ( 2 = 6.54, df= 1, P=.01, OR = 3.44, CI = 1.36, 8.69), and significant main effects for treatment condition ( 2 = 4.42, df= 1, P=.03, OR = 3.52, CI = 1.10, 11.29), number of cigarettes at baseline ( 2=8.12, df=1, P=.004, OR=2.01, 95% CI = 1.25, 3.23), and previous quit attempts ( 2 = 7.23, df= 1, P=.007, OR = 1.03, 95% CI = 1.01, 1.06). Propensity score was not a significant contributor. The treatment condition xnumber of cigarettes smoked at baseline interaction is shown in Figure 3
In testing the third hypothesis, that staged care intervention participants would have more stringent smoking cessation goals, it was necessary to collapse the 6 response categories from the Thoughts about Abstinence Questionnaire (TAQ) into 3 categories because of small sample size in the categories that asked questions about controlled or occasional usequit forever (n=101), controlled/occasional use (n=146), and change not a goal (n=62). The GEE indicated a significant effect for propensity score ( 2=8.36, df=1, P=.004, OR= 7.67, 95% CI=1.99, 29.63), as well as time ( 2=6.72, df=1, P=.01, OR=1.14, 95% CI= 1.03, 1.25) and treatment ( 2=4.50, df=1, P=.03, OR=1.46, 95% CI=1.03, 2.06). Inspection of mean differences in percentages of participants not having change as a goal at each time point indicated no difference between experimental (15.1%) and control conditions (14.7%). The significant treatment condition effect suggested that more staged care intervention participants endorsed a goal of complete and continued abstinence than did control participants (43.9% vs 34.4%); conversely, staged care intervention participants were less likely to endorse a goal of controlled use (41.4%) than brief contact control participants (50.5%). Hypothesis 4 was not supported; there were no significant relationships between abstinence and the BDI, either as main or interaction effects, at any assessment. Replication of the tests of hypotheses on the subsample of participants diagnosed with MDD (n=307) produced results that paralleled those reported for the entire sample of N=322.
We examined the effect of opting for cessation treatment, offered as part of staged care intervention, on abstinence. Enrollees in cessation treatment were more likely to report abstinence at 1 of the 4 follow-up assessments (
Smokers in treatment for depression were helped by an intervention integrating motivational feedback plus medication and psychological intervention. They were more likely to be abstinent, to make at least 1 quit attempt if they were a heavier smoker, and to have a more stringent abstinence goal. Thus, the intervention enhanced 3 important components of abstinence: intention to change, attempting to change, and success in changing. An index of pathology, the BDI-II, did not predict abstinence. The latter finding suggests that depressive symptomatology and responsiveness to smoking interventions may be independent in mental health outpatients and that smoking cessation programs should be offered regardless of symptom severity in this population. Differences between conditions were found at months 12 and 18, a finding which also parallels that found in comparable interventions in the general population12,15 This finding, in concert with evidence of efficacy and lack of correlation of depression severity and abstinence, buttresses a core conclusion emanating from this study: smokers in mental health treatment for depression are responsive to widely implemented interventions, and their behavior in response to these interventions parallels that found in the general population of smokers. In an earlier paper, we examined the applicability of the Stages of Change model to this sample at baseline and found the patterns of relationships paralleled those for the general population, also supporting this conclusion.32
Limitations
Conclusions
The study was supported by the National Institute on Drug Abuse (grants P50 DA09253, T32 DA07250, and K05 DA016752) The authors thank Kevin Delucchi and Constance Weisner for their consultation, the clinical staff of Kaiser Permanente Northern California, the Langley Porter Psychiatric Institute for their assistance, and Lorel Hiramoto for manuscript preparation and editing.
Human Participant Protection
Peer Reviewed
Contributors Accepted for publication January 20, 2006.
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