Judith J. Prochaska, Ph.D. - US grants

DESCRIPTION (provided by applicant): Nicotine dependence is the most prevalent substance abuse disorder among psychiatric patients, a group that accounts for 44% of the U.S. tobacco market. While numerous trials have established the effectiveness of smoking cessation interventions for hospitalized medical patients, psychiatric inpatients have largely been excluded. The objective of this proposal is to support the candidate's development of skills to perform patient-oriented research in the area of tobacco dependence treatment with comorbid smokers in new settings. The career plan includes training in clinical trials, cost-effectiveness, and psychopharmacology. The UCSF Department of Psychiatry and the NIDA-funded P50 San Francisco Treatment Center provide an exceptional environment for developing research investigators. The primary mentor, Dr. Sharon Hall, is a leading expert in the treatment of nicotine dependence and other drugs of abuse. Her extensive research background includes treatment of comorbid smokers in psychiatric settings. The primary specific aim of the research plan is to test in a randomized clinical trial (N=300) a series of hypotheses concerning the efficacy of an extended expert-system intervention plus nicotine replacement therapy (NRT) for treating tobacco dependence among patients hospitalized on a smoke-free psychiatric unit. It is hypothesized that the intervention will be more effective than the enhanced standard care control condition (on-unit NRT with self-help brochure) in producing biochemically verified abstinence from cigarettes at 3-, 6-, 12-, and 18-months follow up. Additionally, intervention participants will exhibit greater stage progression, commitment to abstinence, and delay in relapse to smoking following hospital discharge, factors predictive of future success with quitting smoking. Smoking cessation treatments have been shown to be highly cost-effective with the general population of smokers, and cost is likely to be a consideration in efforts to incorporate additional services into an inpatient psychiatric setting. Therefore, a secondary specific aim is to model the cost-effectiveness of the smoking cessation intervention. Intervention efficacy will be examined in a university-based psychiatric inpatient unit. A smaller pilot study (N=48) will examine translation of the intervention to a county hospital serving a more diversified patient population. Findings will be used in submission of an R01 application to conduct a multisite randomized trial.

DESCRIPTION (provided by applicant): The overall goal of this research is to identify efficacious strategies for treating tobacco dependence among adult smokers hospitalized with severe mental illness. Nicotine dependence is the most prevalent substance abuse disorder among psychiatric patients, a group that accounts for a staggering 44% to 46% of the US tobacco market16, 17. In terms of dollars spent, this equates to $39 billion in annual tobacco sales18. While numerous trials have established the effectiveness of smoking cessation interventions for hospitalized medical patients, little research has targeted the acute psychiatric inpatient setting19. The American Psychiatric Association's tobacco treatment guidelines identify psychiatric hospitalization as an ideal opportunity for promoting smoking cessation1. Individuals with mental illness have lower quit rates and may be less motivated and prepared to quit in the near future than the general population20-22. Thus, sufficiently intense, multi- component interventions are needed that address both the physiological and behavioral aspects of nicotine dependence and assist smokers at all stages of readiness through the quitting process23. Using a three group additive design, the proposed randomized clinical trial (N=1100) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The application builds upon Dr. Prochaska's K23 mentored career development award and seeks to determine: (i) whether the initial successes seen in an academic-based psychiatric hospital can be replicated in a larger and more diverse patient population recruited from a community hospital;and (ii) if more extended and intensive clinician-delivered treatment can outperform our current best practices. The three groups are: (1) Usual Care (N=150) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization;(2) Brief Treatment (N=475) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization;(3) Extended Treatment (N=475) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment. We hypothesize that the extended treatment will outperform the brief treatment, and that both treatment groups will be more effective than usual care in producing quit attempts and ultimately abstinence from cigarettes. Secondary aims will model the cost-effectiveness of the treatment conditions;examine moderators and mediators of treatment outcomes;and prospectively examine the relation between changes in smoking, mental health functioning, and use of other substances over time. Public Health Relevance Statement: Individuals with mental illness in the US are dying, on average, 25 years prematurely, with tobacco-related illnesses of cardiovascular and lung disease and cancer identified as chief causes24. Despite the high prevalence of smoking, low rates of quitting, and devastating health effects, clinical treatment research with smokers with mental illness remains limited. This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units in a community hospital.

The theme of this Center, continuing and extended care models for drug abuse treatment, affords greater opportunity to address the broader health needs of patients over time. Risk behaviors tend to co-occur, and people who abuse alcohol or other drugs are likely to carry additional risks, such as tobacco use, poor diet, physical inactivity, stress and distress, and poor sleep quality. Targeting change in multiple risks offers the potential of increased health benefits, maximized health promotion, and reduced medical costs. Yet, controversies remain regarding how to, and even whether to, assess and treat the multiple comorbid conditions with which patients present. Proceeding in two phases, this Integrative component will provide unique information on the multiple behavioral risks, health functioning, and comprehensive treatment needs of 1200 clients in drug abuse treatment in three very different systems of care: a county public health buprenorphine clinic, a large non-profit integrated managed care health plan, and a Veteran's Affairs medical center. In Phase I, 900 participants from Drs. Hall's and Weisner's components will complete a health risk assessment of 16 behaviors that also assesses participants' stage of change. The primary aims are to examine: the prevalence of multiple risk behaviors and motivation to change among individuals in drug treatment; the association between multiple risk behaviors and health-related quality of life; covariation in changes in risk behaviors; and the medical costs associated with multiple risks and changes over 18-months time. Findings will identify treatment needs and prioritize intervention targets for the pilot study in Phase II. Phase II pilots and evaluates, in a randomized controlled thai, an Innovative, online, extended-care, computer-delivered and stage-tailored health risk intervention (S-HRI) with 300 participants in drug abuse treatment. The S-HRI provides feedback on participants' stages of change for each risk with recommendations on the single most important step they can take to begin progressing. A counselor will review the report with participants and provide motivational interviewing (Ml) coaching and referrals to relevant behavior change services. Intervention participants will complete the S-HRI and Ml-coaching sessions at baseline, 3, 6 and 12 months follow-up. Primary hypotheses are that, relative to usual care, the Intervention will result in greater: (1) client engagement with behavior change service referrals, (2) behavioral changes in multiple risks, and (3) improvements In health-related quality of life at 3, 6, 12, and 18 months follow-up. A secondary aim will examine retention in addictions treatment by condition.

DESCRIPTION (provided by applicant) the proposed research will evaluate the efficacy of two culturally-tailored technology- mediated disease prevention interventions for supporting change in multiple risk behaviors in rural Alaska Native (AN) men and women. Directly informed by the research team's fieldwork over the past 6 years in rural Alaska, continued community partnership with the tribes, and ethnographic research, the interventions will be tailored to AN health needs and values to target 5 of the American Heart Association's 7 Strategic Impact Goals for 2020. In a randomized controlled 2-group design, the trial will compare two active treatment conditions: Group 1 targets tobacco and physical activity; Group 2 targets control of hypertension and hypercholesterolemia (HTN-HCL) through medication adherence and nutritional changes. Both conditions utilize trans theoretical model-tailored, computerized interventions, delivered via telemedicine by Indigenous-focused counselors located in Anchorage reaching AN people in their rural home villages. Computerized intervention contacts occur at baseline, 3-, 6- and 12-months with final assessment at 18-months. Study design provides an equivalent contact time and technology comparison; facilitates individual-level randomization within communities, as all participants receive highly individualized counseling and intervention materials; and allows for comparison of traditional risk factor (HTN-HCL) versus risk behavior (tobacco/ physical activity) interventions. Participants (N=300) will be daily smokers with at least one additional cardiovascular disease risk factor (e.g., inactivity, overweight, HTN, HCL) or established vascular disease. The trial aims to reach AN people regardless of residential location or intention to change. The primary hypothesis is that Group 1 will achieve significantly greater biochemically- confirmed tobacco abstinence than Group 2 through 18-months follow-up and secondarily will significantly increase their physical activity. Secondary hypotheses are that Group 2 will achieve significantly greater control of HTN and HCL than Group 1 through (i) medication compliance and (ii) dietary change. Tertiary aims will: (a) compare the interventions on overall behavior change; (b) model cost-effectiveness and budgetary impact of each intervention; and (c) examine moderators/mediators of treatment outcome, including the trans-3'-hydroxycotinine to cotinine ratio, a noninvasive measure of nicotine metabolism rate. The proposal combines technology, pharmacology, behavioral science, and health economics for advancing the health of AN people who face significant health disparities with limited access to interventions given their isolated geographics.

? DESCRIPTION (provided by applicant): Social Media Technology for Treating Tobacco Addiction. The internet was built for communication. This research project, with its cutting-edge social network approaches and analyses, will examine the potential of the internet, and more specifically social media, to engage health communications for quitting smoking and preventing relapse for addiction treatment and cancer prevention. Further, the design tests the personalized benefits and treatment processes of a women-centered internet cessation intervention. With initial funding from an NIH R34 innovation award, we developed and evaluated a novel online social media intervention for tobacco cessation called Tweet2Quit. Tweet2Quit is a 100-day online intervention that uses a novel, low cost, automated approach to encourage and direct peer-to-peer social support for quitting smoking. Private Twitter groups of 24 smokers are set up, and engagement is encouraged and directed by daily auto feedback and daily auto messages that suggest discussion topics consistent with US treatment guidelines for tobacco use cessation. In a randomized controlled trial (N=160), all participants received advice to quit, referral to the NCI Smokefree.gov website, and 8 weeks of nicotine patch (usual care); and half were then randomized to a Tweet2Quit peer support group to test the net benefit of the social media intervention. At 60-days follow- up, Tweet2Quit participants reported 40% sustained abstinence compared to 20% for controls (p=.017), and engagement in the intervention was related to abstinence (p<.001). Consistent with the tobacco treatment literature, in both study conditions, men were more likely to quit smoking than women, and the gender effect in Tweet2Quit was moderate (d=.55). Notably, women in Tweet2Quit tweeted as much as the men, though the content differed thematically. The proposed randomized controlled evaluation (N=960) of the Tweet2Quit intervention will biochemically verify abstinence out to 6-months follow-up and will test the personalized benefit for women of a women-only versus co-ed Tweet2Quit group. In a 3-arm design, we will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-women only. Each 24-person Tweet2Quit group will include 12 buddy pairs based on similarity in demographics and abstinence goals. Also automated pattern detection will identify dips in tweeting and trigger automated alerts and engagement strategies. Our primary aims test hypothesis 1: Relative to usual care (n=240), Tweet2Quit-coed groups (n=480) will achieve significantly greater bioconfirmed sustained abstinence out to 6-months follow-up, and hypothesis 2: Women in Tweet2Quit will achieve significantly greater bioconfirmed 6-months abstinence in woman-only groups (n=240) vs. coed groups (n=240 women). Our secondary aims are to test the same hypotheses based on 3-month (end of treatment) sustained abstinence and 7-day point prevalence at 1, 3, and 6 months. Exploratory aims will study the Tweet2Quit groups' social network structures with a focus on the identification of buddy pairs and social brokers and test if these relationships are stronger for women in women-only groups versus women in coed groups of Tweet2Quit.

? DESCRIPTION (provided by applicant): This grant will continue the funding of a successful, 40-year training program in cardiovascular disease (CVD) prevention. The program's objective is to train behavioral, epidemiological and clinical scientists to conduct interdisciplinary and translational population-level research aimed at the prevention of CVD and a reduction in health disparities. The training focuses on direct research experience in an existing excellent interdisciplinary research environment, the Stanford Prevention Research Center (SPRC), which includes community, policy, epidemiologic, behavioral, and clinical research that totals ~$11 million annually, primarily from the NIH. This renewal coincides with a period of unprecedented growth and innovation for SPRC. A new chair leads the division, Dr. John Ioannidis, 4 new faculty have been added, and $15 million in unrestricted funding has been obtained recently. These funds will create the infrastructure for a Wellness Living Laboratory (WELL), a bold and ambitious 5-year effort to create a registry of tens of thousands of participants, citizen scientists, initially in our extraordinarily diverse Santa Clara County andin China, who will have the opportunity to participate in an ongoing series of nested RCTs while simultaneously being followed as part of a long-term cohort. The SPRC faculty are collaborating to build this paradigm-shifting model of population science that will provide additional unique and cutting edge opportunities for postdoctoral fellows to conduct CVD-related research. WELL will complement the continued highly productive portfolio of innovative and impactful NIH-funded research of SPRC faculty (e.g., Virtual Advisors for Physical Activity Promotion in Aging Latino Communities, Studying Social Factors in Sodium Consumption to Reduce Hypertension Disparities). Trainees work closely with 1 or more faculty and join a research team where they actively learn about study design and methods, data collection and analyses, manuscript preparation, results dissemination, and grant preparation, with ongoing help and support from SPRC statisticians and investigators. The training includes weekly research seminars and research brainstorming sessions, monthly career development seminars, chronic disease prevention course offerings, and selected patient care and teaching experiences. Physician trainees enter a track that includes an optional 1-year MS degree in Epidemiology and Clinical Research. Trainee selection is based on interest in CVD prevention, potential for an academic research career, and demonstrated excellence. Of the 30 postdoctoral fellows completing training in the past 10 years (2005-2014) 26 (87%) currently hold academic or other research positions; of the 39 postdoctoral trainees appointed in the past 10 years, 67% (n=26) were women and 21% were under-represented minorities (2 Hispanic, 5 African-American, 1 Native American). We request continued funding for 8 postdoctoral trainees with an MD and/or PhD. (End of Abstract)