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The purpose of this study was to examine the effectiveness of adding the Forever Free relapse prevention materials to telephone counseling provided by the Arkansas quitline. Results suggest that the addition of Forever Free materials to telephone counseling does not improve abstinence rates for those participants who receive at least one session of counseling and nicotine patches; however, for those participants unwilling or unable to receive nicotine patches, the addition of the Forever Free relapse prevention materials doubled the abstinence rate and increased the odds of abstinence by nearly 70% 6 months after treatment (20.9% versus 10.6%; OR=1.69; CI=1.02–2.78; p=0.04). Given the recent proliferation of quitline services and the variety of services provided, these results can address concerns about enhancing treatment outcomes for certain groups.
Tobacco use is the leading cause of preventable death and disease with over 440,000 deaths and over $150 billion in costs annually in the U.S. (CDC, 2002; Mokdad, Marks, Stroup, & Gerberding, 2004). Nearly 20% of adults in the U.S. are daily smokers, most of whom desire to quit and will make a quit attempt this year; however, very few smokers use evidence-based treatments to assist with cessation (ACS, 2009; CDC, 2004; CDC, 2008; DHHS, 2004). Cognitive behavioral therapy for tobacco dependence with nicotine replacement, bupropion, and/or varenicline is the most effective evidence-based treatment for tobacco dependence at this time (Fiore et al., 2008)
Cognitive-behavioral therapy (CBT) for tobacco dependence can be effectively delivered over the telephone (Anderson & Zhu, 2007; Zhu et al., 1996; Zhu et al., 2000). The recent proliferation of telephone counseling for tobacco dependence through “quitlines” is likely to provide more smokers with access to evidence-based treatments. All states in the U.S. as well as the District of Columbia, Puerto Rico, and all Canadian provinces now provide some form of telephone counseling through quitlines (Cummins, Bailey, Campbell, Koon-Kirby, & Zhu, 2007). A recent survey found that nearly all of the 62 quitlines in the U.S. and Canada provide multiple proactive treatment sessions and adjunctive self-help materials; however, there is considerable variability in the amount of treatment and the nature of the services provided as well as amount and nature of the adjunctive services such as the provision of medications (Anderson & Zhu, 2007; Cummins et al., 2007). For instance, 56% of quitlines report that they arrange to provide some form of cessation medications through a variety of mechanisms with just 35% providing free medications, primarily in the form of nicotine replacement therapy (NRT) (Cummins et al., 2007). Regardless of the services provided, most tobacco control programs and quitline venders seek to maximize program outcomes while containing costs.
Although there is a well-documented dose-response relationship between the amount of CBT and treatment outcomes, the amount of treatment contact patients receive, and subsequent program outcomes, are often capped by programmatic or contractual parameters (i.e. cost per minute or session) as well as the number of sessions patients are willing to attend. As with in-person treatment delivery modalities, a significant number of participants discontinue treatment prior to receiving all the treatment content and/or the recommended number of treatment contacts (Hollis et al., 2007; Sheffer, 2009). As more tobacco users utilize quitlines, methods to maximize treatment outcomes for those patients who are unwilling or unable to receive the recommended dose of CBT may be of interest.
Similarly, the addition of medications to CBT can double treatment outcomes; however, with free medications provided by just 35% of quitlines, not all quitline participants are able to obtain medications and even among those quitlines that provide medications, not all participants are willing or able to use medications. Methods to maximize treatment outcomes for those patients who do not receive medications may be of interest as well.
Brandon and colleagues demonstrated that a set of specially developed materials sent to recently quit, untreated smokers significantly reduced relapse (Brandon et al., 2004). These materials consist of eight booklets (called Forever Free), each with unique content that draws on empirical and theoretical research in relapse and relapse prevention (Brandon, Collins, Juliano, & Lazev, 2000; Marlatt, 1985; Shiffman et al., 1986). These materials appear to be both efficacious and cost-effective as a minimal intervention for smokers who have recently attained abstinence (Brandon et al., 2004; Chirikos, Herzog, Meade, Webb, & Brandon, 2004). However, the effectiveness of the booklets has not been tested with tobacco users who have received treatment for tobacco dependence, with or without medications. Most quitlines provide adjunctive materials, although there is, at present, no evidence that these materials enhance outcomes. Given that the Forever Free materials have been shown to be efficacious when delivered as a stand-alone intervention, it was hypothesized that they may also enhance outcomes for quitline patients, especially those who were unable or unwilling to receive the recommended amount of treatment and/or free medications.
This project was initiated as part of an evaluation of a public health program that provided telephone counseling as a treatment for tobacco dependence to Arkansas residents. The objective was to assess the efficacy and cost-effectiveness of using the eight Forever Free booklets to prevent relapse for participants utilizing the Arkansas quitline. The booklets were expected to increase six-month abstinence outcomes, especially for those participants who were unable or unwilling to receive the recommended amount of CBT and/or NRT.
For logistical reasons, a quasi-experimental design was used for this initial test of the effectiveness of the eight Forever Free booklets among quitline callers. The Forever Free booklets were mailed to all quitline callers who ended treatment during a six-week period. For comparison, we included quitline callers whose treatment ended during the months immediately prior and succeeding the six week intervention period. These callers were not sent the Forever Free booklets or any other relapse-prevention materials.
Participants included all Arkansas quitline callers whose primary form of tobacco use was cigarettes and who participated in telephone counseling between March 16, 2006 and July 1, 2006 (n=940) and who did not re-enter counseling within 2 years after completion of their index episode (N = 892). The Intervention (INT) group (n=380) included all participants who consecutively ended treatment (either by completing treatment or ending prematurely) between April 13, 2006 and June 1, 2006. The Comparison (COM) group (n=512) included all participants who consecutively ended treatment 1 month before or 1 month after the INT group. This study was approved by the Institutional Review Board at the University of Arkansas for Medical Sciences.
Multi-component cognitive-behavioral therapy with relapse prevention, a well-established, state-of-the-art, validated treatment for tobacco dependence consistent with the recommendations of the Public Health Service Clinical Practice Guideline was provided to participants free of charge (Chambless et al., 1998; Fiore et al., 2008).
The standardized approach in this manualized treatment has been utilized in numerous studies (Payne, Schare, Levis, & Colletti, 1991; Payne, Smith, Adams, & Diefenbach, 2006; Payne, Smith, McCracken, McSherry, & Antony, 1994). Treatment consisted of six structured, 20–30 minute sessions of content. An overview of the biopsychosocial underpinnings of tobacco dependence was presented in lay language addressing the physiological components (e.g., tolerance and withdrawal symptoms) and learning components (e.g., triggers or cues and tobacco use as reinforcement) of tobacco addiction, as well as the use of tobacco to cope with nicotine-related (e.g., lowered plasma nicotine levels) and nicotine-unrelated (e.g., managing stress) events. A variety of evidence-based cognitive-behavioral components were employed, including scheduled gradual rate reduction, self-monitoring, stimulus control, problem-solving, conflict management, cigarette refusal training, enhancing social support, goal setting, relapse prevention, and stress management (Brown et al., 2001; Brown, Lichtenstein, McIntyre, & Harrington-Kostur, 1984; Cinciripini et al., 1995; Cinciripini et al., 1994; Hatsukami, Dahlgren, Zimmerman, & Hughes, 1988; Murray, Johnston, Dolce, Lee, & O'Hara, 1995; Payne et al., 1991). Session content progressed systematically and was generally scheduled once per week for each of six weeks after the initial assessment. Given that the telephone counseling attracted a wide variety of tobacco users (levels of dependence, educational levels, motivational levels, etc.), flexibility in establishing the quit date as well as the number of treatment contacts to cover the required content was permitted. Participants were able to contact the quitline as needed if issues arose between sessions. Structured protocols and random reviews of digital recordings of the sessions were implemented to enhance treatment fidelity.
Nicotine patches were provided to participants free of charge with a release signed by a prescribing practitioner. Self-help and informational material published by Journeyworks, Inc. and the U.S. Public Health Service was also provided to all participants upon first contact.
Standard demographic, tobacco use history, and clinical information were collected during the intake interview. See Table 1.
The FTND is a 6-item questionnaire assessing tobacco dependence level in smokers. Extensive data attesting to the validity of this instrument is available. Scores from 5–10 indicate a higher dependence level (Fagerstrom & Schneider, 1989; Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991).
The PSS-4 is a 4-item questionnaire assessing stress level. Higher scores indicate greater stress and are associated with poorer outcomes. Mean national levels range from 4.2 to 4.7. Mean levels for smokers are higher (4.8 to 5.9) (Cohen, Kamarck, & Mermelstein, 1983; Cohen & Lichtenstein, 1990).
Based on the Transtheoretical Model, stage of change signifies intention and readiness to quit. Those quit are categorized in the Action stage; if planning to quit in the next 30 days, Preparation; in the next 6 months, Contemplation; and not in the next 6 months, Pre-contemplation (Velicer, Prochaska, Fava, Norman, & Redding, 1998).
Motivation and self-efficacy were measured on a scale of 0–10 with 0 = “not at all” and 10 = “the most ever” using the questions: “How much do you want to quit smoking?” and “How confident are you that you can quit using tobacco and stay quit for good?” (McKee, O'Malley, Salovey, Krishnan-Sarin, & Mazure, 2005; Moolchan, Berlin, Robinson, & Cadet, 2003).
Treatment contact number, the content covered in the call, and other details were routinely recorded in the treatment program records as part of standard data collection for the quitline each time a tobacco treatment specialist communicated with any quitline participant.
As standard quitline protocol, all quitline participants are contacted by a specially trained outcome assessment interviewer by telephone 6 months after the last tobacco treatment contact. Abstinence was assessed by assuming the participant was smoking and asking “How many cigarettes are you smoking on a usual day?” followed by, “Have you smoked any cigarettes in the past 7 days?” Participants were considered abstinent if they answered “zero” and “no,” respectively. Demand characteristics were reduced by assuming participants were smoking when framing the outcome questions and using separate, well-trained, non-clinical staff, blinded to condition, for outcome assessment. Seven-day point prevalence by self-report, without biochemical validation, is considered a valid and reliable method for assessing abstinence and appropriate for this type of program (Hughes et al., 2003).
Penalized imputation (PI), a process associated with intention-to-treat analyses, was used to handle missing data. All missing outcome data points were considered smoking. Although imperfect, this method is traditionally used to estimate outcomes when there is no difference in the rates of missing data between groups (Nelson, Partin, Fu, Joseph, & An, 2009).
In June 2006, a list of participants who completed or terminated telephone-based treatment between April 13, 2006 and May 31, 2006 was extracted from the clinical database. These participants, the INT group (N = 380), were mailed the eight Forever Free booklets in one packet. No other procedure differed from regular clinical practice. The comparison sample consisted of those who completed telephone treatment between March 16 and April 12, 2006 (N=265) and those completing between June 1 and July 1, 2006 (N = 247). All quitline participants were contacted for follow-up 6-months after discontinuing treatment. Quitline staff including tobacco treatment specialists and follow-up interviewers was unaware that some participants had received additional materials.
The data was exported to SPSS version 12 (SPSS, 2008). Descriptive analyses were used to characterize the sample and included analyses of variance (ANOVAs) and chi-square tests to compare the equality of means and proportions between the INT and the COM groups. See Tables 1 and and2.2. In order to account for other known sources of variability, those factors that were found to differ significantly between the two groups were included as covariates in the final model.
Logistic regression was used to predict 6-month outcomes with the main variable of interest (received the Forever Free booklets), and with additional significant covariates included in the model. Within the logistic regression model we tested interactions between the main covariate of interest (receiving the Forever Free booklets) and amount of CBT content received as well as receipt of nicotine patches.
No significant differences were found between the INT and the COM groups for sex, pregnancy status, household income, ethnicity, work status, stage of change, smokeless use, smoking policies in the home, timing of last quit attempt, whether they sought professional help with quitting in the past, readiness to set a quit date, years of education, dependence level, motivation to quit, self-efficacy, and whether or not any nicotine patches were sent. However, significant differences between the INT and the COM groups were found for age, the amount of treatment content, number of treatment contacts, the number of nicotine patched dispensed, and stress level. See Tables 1 and and2.2. The proportion of missing data did not differ between the INT and the COM groups (34.7% versus 40.0%; χ2 = 2.61; df = 1 p=0.11) providing support for using punitive imputation as a method for calculating outcomes.
Because significant differences were found between the groups in age, amount of treatment content, number of treatment contacts, number of patches dispensed, and stress levels, these variables were included as covariates in the logistic regression model in order to account for these differences. Amount of treatment content and number of treatment sessions were highly correlated (Pearson correlation = 0.68; p. < 0.01). When both content and number of contacts were included in the logistic regression models, content accounted for a significant amount of the variance and number of contacts did not. Amount of treatment content and not number of treatment contacts, therefore, was included in the final analyses.
There were proportionately more abstinent participants in the INT group than the COM group 6 months after treatment (20.3% versus 15.0%). However, when the differences between the groups were adjusted for age, amount of treatment content, number of patches dispensed, and stress level, the odds of achieving abstinence due to the receipt of the Forever Free booklets were not significant (OR= 1.15; CI= 0.78–1.67; p=0.48).
We conjectured that the Forever Free materials might be most effective for those callers who received less than the full course of counseling and pharmacotherapy. No significant interaction was found between receiving the Forever Free booklets and amount of treatment content (p=0.28). However, a significant interaction between receiving the Forever Free booklets and receiving the nicotine patches (p=0.03) was found. For those participants who did not receive patches, the effect of receiving the Forever Free booklets was significant (20.9% versus 10.6%; n=587; OR=1.69; CI=1.02–2.78; p=0.04) indicating nearly a 70% increase in the odds of abstinence at 6 months after treatment. For those participants who received patches (n=305), the effect of receiving the booklets was non-significant.
Because the group of participants who did not receive patches appeared to be unique in that they benefited from receiving the Forever Free booklets, further exploration of the characteristics of that group was conducted. Those who did not receive patches were less likely to be retired (3.4% versus 7.2%; χ2 (5, N=890) =12.46; p=.03) and less likely to have sought help in the past (20.2% versus 27.6%; χ2 (1, N=881) =6.19; p=.01); they received fewer sessions (M=4.13 vs. 6.81; F(1,891)=60.84, p <.01), less treatment content (M=3.02 versus 4.16; F(1,891)=74.11, p <.01), and were younger (M=41.50 years versus 44.95 years; F(1,887)=14.33, p <.01), when compared to those who received patches. No differences were found in the frequency of receiving the booklets, and in any of the other variables in Tables 1 and and22 between those who received nicotine patches and those who did not.
The addition of Forever Free relapse prevention materials to quitline treatment does not appear to improve abstinence rates for those participants who receive at least one session of counseling and nicotine patches; however, for those participants unwilling or unable to receive nicotine patches, the addition of the Forever Free relapse prevention materials to counseling nearly doubled the abstinence rate and increased the odds of abstinence 6 months after treatment by nearly 70%. Given the recent proliferation of quitline services and the variety of services provided, these results suggest that the addition of these materials may enhance treatment outcomes for certain groups of callers who are unwilling or unable to receive medication.
Participants unwilling or unable to use NRT or other medications will self-select in any clinical population and are often a significant proportion of those who present for treatment. In Arkansas, this subgroup consisted of nearly one-third of callers. Although no less dependent on nicotine, these callers were younger, less likely to have sought professional help in the past with quitting, and likely to receive less counseling. For this subgroup, the receipt of the Forever Free booklets significantly increased the odds of abstinence 6 months after treatment.
Most quitline venders provide self-help materials that address cessation and relapse-prevention. However, the Forever Free booklets are much more extensive (8 booklets of 12–16 pages each) than traditional self-help materials. When they were added as an additional component to the Arkansas quitline treatment, the Forever Free materials appeared to have little or no effect on outcomes among participants who had already received both counseling and nicotine patches. The booklets were most beneficial to callers who did not use pharmacotherapy. Consequently, the booklets would appear to be most helpful to those quitlines that do not provide pharmacotherapy, or to those callers who for one reason or another do not receive or use pharmacotherapy despite its availability. It should be noted, though, that the Arkansas quitline offered more intensive counseling than do many state quitlines. Consequently, the content provided by the Forever Free booklets may have been redundant with the content of the counseling sessions. It remains to be seen whether this relapse-prevention intervention would demonstrate greater effectiveness as a supplement to the less intensive counseling offered by many quitlines. It also must be noted that the Forever Free relapse prevention materials are unique in that they were developed, tested, and found to be efficacious in previous clinical trials with untreated populations. It is not known whether other relapse-prevention materials would be similarly effective.
Two main limitations of the study should be noted. First, we used a quasi-experimental design that needs to be replicated using a true experimental design in which quitline callers are randomized to Forever Free versus usual care conditions. It would also be informative to systematically vary the amount of both CBT content and pharmacotherapy that is provided by the quitline. Because quitlines already vary on these characteristics, this could be accomplished by testing the Forever Free materials across multiple quitlines that differ in their provision of these standard components. A second limitation is that in the present study we distributed the Forever Free booklets simultaneously to all quitline callers who ended telephone treatment during the prior 6 weeks. It would be most logical to provide these relapse-prevention materials either during the course of telephone counseling or immediately thereafter. Because some of our participants received the booklets up to 6 weeks after counseling ended, the efficacy of the booklets may have been compromised. Brandon and colleagues found that among self-quitters, the booklets were only effective for those who had quit smoking within the 12 weeks prior to receiving the first booklet (Brandon et al., 2000). In the current study, some of our participants received their booklets very close to that threshold.
Despite these limitations, results of the present study suggest that the Forever Free reapse prevention materials can be effective as a supplement to standard telephone counseling and provided by a quitline. In this case, the effect was found only among quitline participants who did not receive NRT, but future, controlled research is necessary to specify the parameters of this effect. Meanwhile, because medications are among the more expensive components of quitline treatment, many state tobacco control programs do not consistently provide NRT. For those states, the addition of the Forever Free relapse prevention materials may be a cost-effective method of enhancing quitline outcomes.
Treatment provided by the Arkansas quitline was funded through a contract with the Arkansas Department of Health with funds from the Master Settlement Agreement. This study was also supported by an award from the National Institute of Health (RR020146).
Christine E. Sheffer, Health Behavior and Health Education, Fay W Boozman College of Public Health, Fay W Boozman College of Public Health, 4301 West Markham Street, Little Rock, AR 72205.
Maxine Stitzer, Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Johns Hopkins Bayview Medical Center, 5510 Nathan Shock Drive, Baltimore, MD 21224.
Thomas Brandon, Professor of Psychology & Oncologic Sciences, University of South Florida and Director, Tobacco Research & Intervention Program, H. Lee Moffitt Cancer Center & Research Institute, 4115 E. Fowler Ave, Tampa, FL 33617.
Zoran Bursac, Department of Biostatistics, Fay W Boozman College of Public Health, University of Arkansas for Medical Sciences, 4301 West Markham Street, Little Rock, AR 72205.