James O. Prochaska, Ph.D - US grants

The proposed research is designed to develop more effective self-change models and materials for smoking cessation. Although smoking is the most preventable cause of cancer, 54 million Americans continue to smoke. Sixty percent of these smokers tried to quit but failed. Most smokers report that they would not attend formalized treatment programs but would use self-help materials. Unfortunately, available self-help manuals have been as ineffective as formalized treatment programs. Consequently, there is an urgent need to develop and disseminate more effective models and materials for individuals wishing to quit smoking on their own. The proposed research is a continuation of five years of research on self-change approaches to smoking cessation. These studies have enhanced a Transtheoretical Model which involves ten change processes receiving differential use during four stages of change: precontemplation; contemplation; action; and maintenance. Causal modeling would be continued on a two-year longitudinal data set of 950 smokers and former smokers. Structural analyses would test causal models of the processes which are most effective for the precontemplation, maintenance and relapse stages of change. Relapse analyses of self-changers would identify the antecedents and the positive and negative consequences of relapse. Currently funded Phase II research is developing self-help modules and computer-assisted correspondence courses for the contemplation and action stages. The proposed research would complete Phase II research through the development of modules and correspondence courses for the precontemplation, maintenance and relapse stages. Longitudinal Phase III research would then evaluate four different self-help programs: 1. the combined action and maintenance manuals of the American Lung Association; 2. a more individualized transtheoretical manual that includes modules for five stages of change; 3. a transtheoretical computer assisted correspondence course that provides individualized and interactive applications of the five modules; and 4. a computer and counselor assisted correspondence course that provides individualized, interactive and personalized applications of the five modules. A three year longitudinal analysis of 1600 subjects would provide intensive process and outcome evaluations of the four programs. This research is designed to contribute to cancer control by developing and evaluating more effective self-help models and programs that have potential for providing desirable and cost-effective help to large numbers of individuals wishing to stop smoking.

human therapy evaluation; psychotherapy; behavior modification; cancer prevention; health care model; human subject; neoplasm /cancer education;

The proposed research is designed to develop more effective self-help models and interventions for smoking cessation. Although smoking is the most preventable cause of cancer, 50 million Americans continue to smoke. MOst smokers report that they would not attend formalized treatment programs but would use self-help materials. Consequently, there is an urgent need to develop and disseminate more effective models and interventions for individuals wishing to quit smoking on their own. The proposed research is a continuation of ten years of research on self-change approaches to smoking cessation funded by Grant CA27821. The proposed study will take stage-specific, self-help smoking cessation programs that have been most promising in Phase III research and transfer the technology for dissemination to a larger scale Phase IV defined population of smokers belonging to a Health Maintenance Organization. Our Phase I, II, and III research provides the foundation for investigation of and intervention with subjects at each stage of change: precontemplation, contemplation, ready for action, action, relapse and maintenance. This Phase IV sample of smokers will be recruited proactively, so that more precontemplators and contemplators will comprise this sample. This project will assess how our self-help, stage-specific interventions work by utilizing process-to- outcome measures. In Study I a factorial design will be used which crosses 1, 2, 3, and 6 serial contacts with both interactive, computer-based and non-interactive interventions. Comparisons across different serial contact conditions will clarify serial treatment effects. Planned comparisons will clarify whether interactive, computer-based interventions are more effective and cost-effective compared to non-interactive manuals. Study II compares two enhanced versions of our standard computer interactive program, one utilizing a nicotine fading, hand-held computer modality and the other a counselor calling modality. Data analyses will identify the most effective, cost effective, and generalizable elements of these smoking cessation interventions in preparation for dissemination to larger Phase V populations. This research is designed to contribute to cancer control by developing and evaluating more effective self-help models and interventions that have potential for providing interactive yet cost-effective self-help programs for entire populations of smokers.

Schools and homes are two of the most critical channels for cancer prevention. This project will test the efficacy of stage-matched, proactive, interactive, and individualized interventions delivered through multiple channels (school and home) to two populations (adolescents and parents) on multiple cancer risks (high fat and low fiber diets, smoking, and ultraviolet light exposure). This experimental intervention trial employs 2 (standard health education v. stage-matched computerized and classroom curriculum) X 2 (home-based expert system intervention v. control) X 4 (yearly repeated measures) design. Schools are randomly assigned to standard v. stage-matched curricula and parents who are the primary food preparers are randomly assigned within schools to home intervention or control conditions. Ninth graders in the school intervention will receive over two years a series of eight individualized computer sessions and four social influence-based classroom sessions. Over two years, parents will receive a series of four computer-generated individualized reports along with self-help manuals, designed to facilitate progress through stages of change for each of the parent's relevant risk factors. The four randomized conditions will permit assessments of the impact on students of the innovative school interventions while assessing the effects on parents of the home-based intervention. We will also assess among students in the school-based program the additive effects of a home-based program for their parents and among parents in the home-based program the additive effects of a school- based program for their teenage children. Since over 80% of eligible students and parents are likely to participate, these programs have considerable potential to dramatically increase impacts on three of the most important behavioral risks for cancer.

DESCRIPTION: The proposed research is designed to develop more effective self-help interventions for smoking cessation. Smoking is the most preventable cause of cancer mortality, but 47 million Americans continue to smoke. Smoking cessation clinics have reached only about 1 percent of eligible smokers. Home based programs that are action-oriented reach only about 1-5 percent. In the current study using stage-matched interventions and proactive recruitment 85 percent of a defined population of smokers in an HMO were reached. It is proposed that this marked increase in participation rates needs to be complimented by dramatic increases in cessation rates of the most promising self-help interventions developed to date. The proposed research is a continuation of 15 years of research on self-change approaches to smoking cessation already funded by NIH. This research program has produced models, measures and intervention methods that are having major impacts on the field. The current project has accomplished all of the aims proposed including unprecedented participation rates, individualized and interactive interventions outperforming self-help manuals at 1, 2 3 and 6 series of contacts; enhanced proactive counselor protocols producing high abstinence rates at 12 months, and a low cost single contact expert system producing relatively high abstinence rates. The proposed extension is a population based clinical trial with 5500 smokers proactively recruited from an HMO and randomly assigned to one of nine conditions varying from low to high contact intensity. These conditions include: 1) no treatment; 2) proactive assessment every six months; 3) single expert system intervention; 4) a matched modality intervention combining the best modality for smokers in each of three stages of change; 5)the investigators most effective three intervention expert system; 6) and 7) enhanced personal choice and professional choice versions of the standard systems; 8) an enhanced proactive counseling condition with counselor fading; and 9) a stepped care population program progressing from expert systems, to counseling and nicotine replacement where indicated. Data analyses will identify the most effective, cost-effective and generalizable elements of these smoking cessation interventions in preparation for dissemination to entire populations. This research is designed to continue the investigators' contributions to cancer control by developing and evaluating stage-matched, interactive and proactive self-help interventions that have the potential to produce unprecedented impacts on entire populations of smokers.

DESCRIPTION (Adapted from the Applicant's Abstract): This project applying cognitives in schools with adolescents has four primary aims: 1) to replicate the excellent results found with adolescents who received at school proactive, individualized and interactive multimedia expert systems for smoking, high fat diets and sun exposure. 2) To expand these findings to three additional behavioral risk factors for cancer, namely alcohol abuse, sedentary life-styles and stress; and 3) to enhance our current best practices for smoking, diet and sun exposure by creating an integrated expert system that teaches teenagers the basic principles and processes for changing these and other risk behaviors; 4) to explore the additive effects of treating both students at school and their parents at home (in a parallel Interactive RO1 project entitled "Home Computers for Parents for Six Cancer Risk Factors") compared to treating just the students alone for each of the six target behaviors. This population-based clinical trial employs a 3 X 4 repeated measures design crossing 3 groups (the Best Practices expert systems for smoking, diet and sun exposure; an innovative integrated expert system; and the New Behaviors comparison group that also serves as a distraction placebo control. Fourteen high schools will participate with 3570 ninth graders being randomly assigned to one of the three groups. All participants will receive six 45 minute expert system sessions during their ninth and tenth grades. The expert systems provide normative (compared to their peers) and ipsative (compared to self) feedback on each of the 15 relevant Transtheoretical Model variables for each of their relevant risk factors. These systems are designed to provide guided learning for accelerating and facilitating progress through stages of change. Since nearly 80 percent of eligible students are expected to participate, these programs have considerable potential to produce major population impacts on six of the most important behavioral risks for cancer and other chronic diseases. The project will produce individualized and interactive multimedia computer programs that can be disseminated in a cost-effective manner through schools to help entire populations of adolescents.

Abstract Not Provided.

[unreadable] DESCRIPTION (provided by applicant): The overarching goal is to advance knowledge about long-term maintenance, particularly in older adults, by systematically analyzing maintenance factors in: 1) types of treatment; and 2) types of populations. The research analyzes 14 change processes within and across 10 behaviors that are of increasing significance to the health of aging populations. The 10 behaviors are 1. smoking; 2. alcohol; 3. adherence to anti- hypertensives; 4. adherence to statins; 5. self-monitoring of blood glucose; 6. stress management; 7. depression management; 8. exercise; 9. diet; and 10. sun exposure. The primary goals are: 1) to compare maintenance rates and pathways to maintenance within and between types of treatment (e.g., treatment vs. no-treatment; multiple level treatments vs. single level); and 2) types of populations differing by age, gender, education or ethnicity. The project would assess on which behaviors older adults are better, worse or the same as other adults in maintaining change depending on factors related to motivation, self-efficacy and resistance to change. The project would assess maintenance models specific to each behavior and models that are general across behaviors. The analyses would: 1. Calculate and compare maintenance rates across behaviors for each type of treatment and population; 2. Graphically represent longitudinal use of 14 maintenance factors by three dynatypes (maintainers, relapsers, and non-adopters); 3. Assess statistical differences between the three dynatypes, groups representing treatments or populations, and time; 4. Assess causal influences and mediating effects of the 14 maintenance factors and 5. Identify common and unique use of maintenance factors and mediation models across behaviors by use of meta-analyses. The proposal would be the largest comparative study of maintenance and would analyze 22 studies with over 40,000 participants supported by more than 40 million dollars in grants with co-investigators from multiple disciplines. The knowledge generated would produce 60 publications of importance for theories of behavior change and for interventions for long-term maintenance. Special relevance for older adults includes the identification of maintenance factors related to their doing better, worse or the same in maintaining changes in particular health behaviors. Given increasing risks of developing diseases related to these behaviors, this research has special relevance for prevention and management of chronic diseases in older adults. [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This proposal is submitted in response to PA-07-119 (Health Services Research on the Prevention and Treatment of Drug and Alcohol Abuse) from NIDA and addresses major gaps in health services research for nicotine addiction treatments for entire populations of smokers and for the 80% who are not motivated to quit. Nicotine addiction is just like other drug addictions in terms of breaking the addiction cycle. This research will be done in collaboration with the Health and Wellness Institute founded for dissemination purposes by Blue Cross of Rhode Island which serves over 70% of the state. Health service researchers and providers differ on whether treatment emphasis should be on clinician-based counseling, biologically-based medications, computer-based tailored communications or a combination of these. There is a lack of comparative research on population treatments to compare effectiveness, cost-effectiveness and enhancement of quality of life. Such comparative research would provide health care systems and providers with evidence on how to best serve entire populations of smokers, especially unmotivated smokers who are seriously underserved. This research will compare the four most highly recommended treatments: 1. Motivation Enhancement Therapy (MET) plus NRT;2. Reduction Therapy plus NRT;3.Tailored communications based on the Transtheoretical Model (TTM), and 4. The combination of these treatments. A five group randomized comparative treatment design will compare MET, Reduction, TTM Tailored and combined treatments and assess multiple outcomes at 0, 6, 12, 18 and 24 months. The study will proactively screen the health care system population to identify a sample of 2,500 smokers, including 2,000 unmotivated smokers. Secondary aims will examine cessation outcome trajectories (No Treatment Effects, Stable Effects after treatment, Decreasing Effects or Increasing Effects), and potential mediators of how the treatments work. PUBLIC HEALTH RELEVANCE: If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine Replacement Therapy and Transtheoretical tailored interventions produces an increasing treatment trajectory, it will produce unprecedented impacts with unmotivated smokers specifically and population cessation generally. These recruitment and intervention strategies require limited resources from health care providers and could be readily disseminable to other health care systems for application with populations of smokers, especially unmotivated smokers who have been understudied and underserved.

DESCRIPTION (provided by applicant): This proposal addresses major gaps in health services research for treating nicotine addiction in populations of smokers. One of the most important debates in the field of health services for disease prevention is whether financial incentives should be contingent on participation in evidence-based programs for nicotine addiction, or on actual outcomes, like prolonged abstinence. On one side are growing numbers of employers who advocate for standards based services which reward participants who reach a public health standard like total abstinence. On the other side are long lists of non-profit organizations who support cash incentives for participation but oppose standards based incentives out of concern that significant percentages of populations with and without chronic conditions will not be able to achieve such standards and will suffer as a result. This study is aimed at one of the major gaps in knowledge in this debate, which is the lack of any randomized clinical trial that has compared the impacts of outcomes- and participation-based incentives. This population- based, randomized clinical trial with a sample of 870 smokers will compare long-term abstinence rates in three treatment conditions: 1. Those incentivized for participation in an evidence-based treatment designed for smokers at each stage of change; 2. Those incentivized for biologically validated prolonged abstinence at 6 ($200) and 12 ($250) months who could also choose to participate in the TTM-tailored intervention; and 3. An assessment only control condition incentivized just for research participation. The aims are: 1) To assess whether each treatment group outperforms the controls at 12, 24 and 36 months; 2) To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized; 3) To compare the cost-effectiveness and cost savings of each treatment in a population of mostly unmotivated smokers; 4) To assess the long-term treatment trajectories of each treatment; and 5) To identify mediators of long-term outcomes in each treatment. Innovation in this project is reflected by how many of the aims and themes of this research parallel the NIH (2009) Report's recommendations for innovative research to advance the science of behavior change. They include: 1) the comparison of financial incentives based on treatment participation versus outcomes; 2) the study of treatment adherence and effects of participation on outcomes; 3) the use of tailoring and technology to enhance clinical services; 5) examining treatment efficacy in different subpopulations (e.g., those in different stages of change); 6) comparing cost-effectiveness and cost savings of alternative health services; 7) preparing evidence-based treatments for immediate dissemination; and 8) designing clinical trials that can have immediate impacts on major health service policies. This project has the potential to help fill major knowledge gaps relevant to one of the most critical controversies in the science and service of health behavior change for nicotine addiction. PUBLIC HEALTH RELEVANCE: One of the most important debates in the field of disease prevention is whether financial incentives should be contingent on participation in evidence-based programs for smoking cessation or on actual outcomes, like prolonged abstinence. This study can fill a major knowledge gap in this debate, which is the lack of any population trial that compared the impacts of outcomes- and participation-based incentives in a population of smokers. This research can help policy makers and health service providers choose the incentives approach that provides the most effectiveness, cost-effectiveness and cost-savings for entire populations of smokers.