Professor, Social and Behavioral Sciences
Linda M. Collins is Professor of Global Public Health in the Department of Social and Behavioral Sciences, with a secondary appointment in the Department of Biostatistics. She earned her B.A. in Psychology at the University of Connecticut and her Ph.D. in Quantitative Psychology at the University of Southern California.
Collins’ research interests are focused on the development, dissemination, and application of the multiphase optimization strategy (MOST), a framework for the optimization of behavioral, biobehavioral, and social-structural interventions. The objective of MOST is to improve intervention effectiveness, efficiency, economy, and scalability. She is currently collaborating on research applying MOST in the areas of smoking cessation, the prevention of excessive drinking and risky sex in college students, and HIV services.
Collins’ research has been funded by the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and the National Science Foundation, among others. She has given more than 150 presentations on MOST around the world, and her publications have appeared in journals in the fields of behavioral science, quantitative methodology, medicine, and engineering.
Collins has held tenured faculty positions at the University of Southern California and at Penn State University, where she was Distinguished Professor of Human Development and Family Studies and Director of The Methodology Center. She is a Fellow of the American Psychological Association, the Association for Psychological Science, the Society of Behavioral Medicine, and is a past president of the Society of Multivariate Experimental Psychology and the Society for Prevention Research.
BA, Psychology, University of Connecticut, Storrs, CTPhD, Quantitative Psychology, University of Southern California, Los Angeles, CA
Fulbright Specialist, National University of Ireland Galway (2018)Pauline Schmitt Russell Distinguished Career Award, Pennsylvania State University’s College of Health and Human Development (2017)Evan G. and Helen G. Pattishall Outstanding Research Achievement Award, Pennsylvania State University’s College of Health and Human Development (2011)President’s Award, Society for Prevention Research (2004)Faculty Scholar Medal for the Social and Behavioral Sciences, Pennsylvania State University (2000)Psychology Department Teacher of the Year, University of Southern California (1992)Psychology Department Mentorship Award, University of Southern California (1991)Society of Multivariate Experimental Psychology Award for Distinguished Early Career Contributions to Multivariate Behavioral Research (1991)
Behavioral ScienceCost EffectivenessCost-effective Health Programs and PoliciesDissemination and Implementation of Evidence-based Programs
African American/Black and Latino Adults with Detectable HIV Viral Load Evidence Substantial Risk for Polysubstance Substance Use and Co-occurring Problems: A Latent Class AnalysisCleland, C. M., Gwadz, M., Collins, L. M., Wilton, L., Sherpa, D., Dorsen, C., Leonard, N. R., Cluesman, S. R., Martinez, B. Y., Ritchie, A. S., & Ayvazyan, M.
Journal titleAIDS and BehaviorAbstractSubstance use problems are highly prevalent among persons living with (PLWH) in the United States and serve as serious barriers to engagement in HIV care. Yet, in contrast to studies of single substances, little is known about patterns of polysubstance use in this population. Moreover, other risk factors (e.g., financial hardship, incarceration, homelessness, and mental health distress) are also prevalent and complicate HIV management. The present study drew on a cross-sectional survey with African American/Black and Latino (AABL) adult PLWH from low socioeconomic status backgrounds in New York City who were insufficiently engaged in HIV care and evidenced detectable HIV viral load (N = 512). We used latent class analysis (LCA) to explore patterns of polysubstance use and their relationships to financial hardship, incarceration, homelessness, and mental health. LCA yielded three substance use classes: Class 1, a high polysubstance use/high-risk substance use class (9%); Class 2, a polysubstance use/moderate substance use risk class (18%); and Class 3, a moderate polysubstance use/moderate-to-low-risk substance use class (74%). Mental health symptoms were prevalent in all classes, but Class 1 had greater mental health distress than the other two classes. Current homelessness was more prevalent in Classes 1 and 2. We cannot end the HIV epidemic without engaging and treating AABL PLWH who have serious barriers to engagement along the HIV care continuum, and who evidence polysubstance use along with co-occurring risk factors. Clinical settings can develop outreach and engagement approaches to bring this subpopulation of PLWH into care settings, and further, specialized services are needed to successfully screen, treat, and retain them.
Black and Latino Persons Living with HIV Evidence Risk and Resilience in the Context of COVID-19: A Mixed-Methods Study of the Early Phase of the PandemicGwadz, M., Campos, S., Freeman, R., Cleland, C. M., Wilton, L., Sherpa, D., Ritchie, A. S., Hawkins, R. L., Allen, J. Y., Martinez, B. Y., Dorsen, C., Collins, L. M., Hroncich, T., Cluesman, S. R., & Leonard, N. R.
Journal titleAIDS and Behavior
Page(s)1340-1360AbstractThe COVID-19 pandemic has great potential to disrupt the lives of persons living with HIV (PLWH). The present convergent parallel design mixed-methods study explored the early effects of COVID-19 on African American/Black or Latino (AABL) long-term survivors of HIV in a pandemic epicenter, New York City. A total of 96 AABL PLWH were recruited from a larger study of PLWH with non-suppressed HIV viral load. They engaged in structured assessments focused on knowledge, testing, trust in information sources, and potential emotional, social, and behavioral impacts. Twenty-six of these participants were randomly selected for in-depth semi-structured interviews. Participants were mostly men (64%), African American/Black (75%), and had lived with HIV for 17 years, on average (SD=9 years). Quantitative results revealed high levels of concern about and the adoption of recommended COVID-19 prevention recommendations. HIV care visits were commonly canceled but, overall, engagement in HIV care and antiretroviral therapy use were not seriously disrupted. Trust in local sources of information was higher than trust in various federal sources. Qualitative findings complemented and enriched quantitative results and provided a multifaceted description of both risk factors (e.g., phones/internet access were inadequate for some forms of telehealth) and resilience (e.g., “hustling” for food supplies). Participants drew a direct line between structural racism and the disproportional adverse effects of COVID-19 on communities of color, and their knowledge gleaned from the HIV pandemic was applied to COVID-19. Implications for future crisis preparedness are provided, including how the National HIV/AIDS Strategy can serve as a model to prevent COVID-19 from becoming another pandemic of the poor.
Evaluating four motivation-phase intervention components for use with primary care patients unwilling to quit smoking: a randomized factorial experimentCook, J. W., Baker, T. B., Fiore, M. C., Collins, L. M., Piper, M. E., Schlam, T. R., Bolt, D. M., Smith, S. S., Zwaga, D., Jorenby, D. E., & Mermelstein, R.
Journal titleAddictionAbstractAims: To assess the effectiveness of intervention components designed to increase quit attempts and promote abstinence in patients initially unwilling to quit smoking. Design: A four-factor, randomized factorial experiment. Setting: Sixteen primary care clinics in southern Wisconsin. Participants: A total of 577 adults who smoke (60% women, 80% White) recruited during primary care visits who were currently willing to reduce their smoking but unwilling to try to quit. Interventions. Four factors contrasted intervention components administered over a 1-year period: (i) nicotine mini-lozenge versus none; (ii) reduction counseling versus none; (iii) behavioral activation (BA) counseling versus none; and (iv) motivational 5Rs counseling versus none. Participants could request cessation treatment at any time. Measurements: The primary outcome was 7-day point-prevalence abstinence at 52 weeks post enrollment; secondary outcomes were point-prevalence abstinence at 26 weeks and making a quit attempt by weeks 26 and 52. Findings: No abstinence main effects were found but a mini-lozenge × reduction counseling × BA interaction was found at 52 weeks; P = 0.03. Unpacking this interaction showed that the mini-lozenge alone produced the highest abstinence rate (16.7%); combining it with reduction counseling produced an especially low abstinence rate (4.1%). Reduction counseling decreased the likelihood of making a quit attempt by 52 weeks relative to no reduction counseling (P = 0.01). Conclusions: Nicotine mini-lozenges may increase smoking abstinence in people initially unwilling to quit smoking, but their effectiveness declines when used with smoking reduction counseling or other behavioral interventions. Reduction counseling decreases the likelihood of making a quit attempt in people initially unwilling to quit smoking.
Stopping, starting, and sustaining HIV antiretroviral therapy: a mixed-methods exploration among African American/Black and Latino long-term survivors of HIV in an urban contextGwadz, M., Cleland, C. M., Freeman, R., Wilton, L., Collins, L. M., L. Hawkins, R., Ritchie, A. S., Leonard, N. R., Jonas, D. F., Korman, A., Cluesman, S., He, N., & Sherpa, D.
Journal titleBMC public health
Issue1AbstractBackground: Although periods of HIV antiretroviral therapy (ART) discontinuation have deleterious health effects, ART is not always sustained. Yet, little is known about factors that contribute to such ART non-persistence among long-term HIV survivors. The present study applied a convergent parallel mixed-methods design to explore the phenomena of stopping/starting and sustaining ART, focusing on low-socioeconomic status African American or Black and Latino persons living with HIV (PLWH) who face the greatest challenges. Methods: Participants (N = 512) had poor engagement in HIV care and detectable HIV viral load. All received structured assessments and N = 48 were randomly selected for in-depth interviews. Quantitative analysis using negative binomial regression uncovered associations among multi-level factors and the number of times ART was stopped/started and the longest duration of sustained ART. Qualitative data were analyzed using a directed content analysis approach and results were integrated. Results: Participants were diagnosed 18.2 years ago on average (SD = 8.6), started ART a median five times (Q1 = 3, Q3 = 10), and the median longest duration of sustained ART was 18 months (Q1 = 6, Q3 = 36). Factors associated with higher rates of stops/starts were male sex, transgender identity, cannabis use at moderate-to-high-risk levels, and ART- and care-related stigma. Factors associated with lower rates of stops/starts were older age, more years since diagnosis, motivation for care, and lifetime injection drug use (IDU). Factors associated with longer durations of sustained ART were Latino/Hispanic ethnicity, motivation for ART and care, and recent IDU. Factors associated with a shorter duration were African American/Black race, alcohol use at moderate-to-high-risk levels, and social support. Qualitative results uncovered a convergence of intersecting risk factors for stopping/starting ART and challenges inherent in managing HIV over decades in the context of poverty. These included unstable housing, which contributed to social isolation, mental health distress, and substance use concerns, the latter prompting selling (“diverting”) ART. Primarily complementary quantitative and qualitative findings described mechanisms by which risk/protective factors operated and ways PLWH successfully restart and/or sustain ART. Conclusions: The field focuses substantially on ART adherence, but greater attention to reducing the frequency of ART non-persistence is needed, along with creating social/structural conditions favorable for sustained ART.
A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN StudySpring, B., Pfammatter, A. F., Marchese, S. H., Stump, T., Pellegrini, C., McFadden, H. G., Hedeker, D., Siddique, J., Jordan, N., & Collins, L. M.
Page(s)1652-1662AbstractObjective: Intensive behavioral obesity treatments face scalability challenges, but evidence is lacking about which treatment components could be cut back without reducing weight loss. The Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity (Opt-IN) study applied the Multiphase Optimization Strategy to develop an entirely remotely delivered, technology-supported weight-loss package to maximize the amount of weight loss attainable for ≤$500. Methods: Six-month weight loss was examined among adults (N = 562) with BMI ≥ 25 who were randomly assigned to conditions in a factorial experiment crossing five dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training). Results: About 84.3% of participants completed the final assessment. The treatment package yielding maximum weight loss for ≤$500 included 12 coaching calls, buddy training, and primary care provider progress reports; produced average weight loss of 6.1 kg, with 57.1% losing ≥5% and 51.8% losing ≥7%; and cost $427 per person. The most expensive candidate-treatment component (24 vs. 12 coaching calls) was screened out of the optimized treatment package because it did not increase weight loss. Conclusions: Systematically testing each treatment component’s effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.
A Tribute to the Mind, Methodology and Mentoring of Wayne VelicerHarlow, L. L., Aiken, L., Blankson, A. N., Boodoo, G. M., Brick, L. A. D., Collins, L. M., Cumming, G., Fava, J. L., Goodwin, M. S., Hoeppner, B. B., MacKinnon, D. P., Molenaar, P. C., Rodgers, J. L., Rossi, J. S., Scott, A., Steiger, J. H., & West, S. G.
Journal titleMultivariate Behavioral ResearchAbstractWayne Velicer is remembered for a mind where mathematical concepts and calculations intrigued him, behavioral science beckoned him, and people fascinated him. Born in Green Bay, Wisconsin on March 4, 1944, he was raised on a farm, although early influences extended far beyond that beginning. His Mathematics BS and Psychology minor at Wisconsin State University in Oshkosh, and his PhD in Quantitative Psychology from Purdue led him to a fruitful and far-reaching career. He was honored several times as a high-impact author, was a renowned scholar in quantitative and health psychology, and had more than 300 scholarly publications and 54,000+ citations of his work, advancing the arenas of quantitative methodology and behavioral health. In his methodological work, Velicer sought out ways to measure, synthesize, categorize, and assess people and constructs across behaviors and time, largely through principal components analysis, time series, and cluster analysis. Further, he and several colleagues developed a method called Testing Theory-based Quantitative Predictions, successfully applied to predicting outcomes and effect sizes in smoking cessation, diet behavior, and sun protection, with the potential for wider applications. With $60,000,000 in external funding, Velicer also helped engage a large cadre of students and other colleagues to study methodological models for a myriad of health behaviors in a widely applied Transtheoretical Model of Change. Unwittingly, he has engendered indelible memories and gratitude to all who crossed his path. Although Wayne Velicer left this world on October 15, 2017 after battling an aggressive cancer, he is still very present among us.
itMatters: Optimization of an online intervention to prevent sexually transmitted infections in college studentsWyrick, D. L., Tanner, A. E., Milroy, J. J., Guastaferro, K., Bhandari, S., Kugler, K. C., Thorpe, S., Ware, S., Miller, A. M., & Collins, L. M.
Journal titleJournal of American College Health
Page(s)1-11AbstractObjective: To describe an iterative approach to developing an online intervention targeting the intersection of alcohol use and sexual behaviors among first year college students. Methods and Participants: Using the multiphase optimization strategy (MOST), we conducted two iterative optimization trials to: (1) identify candidate intervention components (i.e., descriptive norms, injunctive norms, outcome expectancies, perceived benefits of protective behavioral strategies, and self-efficacy to use strategies); (2) revise components; and (3) identify the optimized intervention. Participants were first year college students at six geographically diverse universities (optimization trial 1 N = 5,880; optimization trial 2 N = 3,551) Results: For both optimization trials, the results indicated that only descriptive and injunctive norms produced a significant effect (p<.05). Conclusions: The iterative process of MOST allowed us to develop an optimized intervention which is an essential tool to maximize intervention effectiveness and efficiency to improve uptake, sustainability, and public health impact.
Predictors of smoking cessation attempts and success following motivation-phase interventions among people initially unwilling to quit smokingKlemperer, E. M., Mermelstein, R., Baker, T. B., Hughes, J. R., Fiore, M. C., Piper, M. E., Schlam, T. R., Jorenby, D. E., Collins, L. M., & Cook, J. W.
Journal titleNicotine and Tobacco Research
Page(s)1446-1452AbstractIntroduction: Most people who smoke cigarettes are not willing (ie, not ready) to make a quit attempt (QA) at any given time. Unfortunately, interventions intended to increase QAs and the success of QAs are only modestly effective. Identifying processes leading to QAs and quitting success could guide intervention development. Aims and Methods: This is a secondary analysis of a randomized factorial trial of 6 weeks of motivation-phase interventions among primary care patients (N = 517) who were initially unwilling to quit but were willing to reduce their smoking. Using logistic regression, we controlled for treatment condition and tested whether baseline or change in smoking-related constructs after 6 weeks of treatment predicted (1) making an at least 24 h QA between weeks 6 and 26 and (2) quitting success at week 26 (7-day point-prevalence abstinence among those who made a QA). Predictors included cigarettes/day, time to first cigarette, motivation to quit, quitting self-efficacy, anticipated urges to smoke if quit, positive affect, negative affect, and time spent around others who smoke. Results: In multivariable models that included all smoking-related constructs, changes in the following variables predicted initiating a QA above and beyond other variables: greater baseline time to first cigarette (odds ratio [OR] = 1.60), increases in time to first cigarette (OR = 1.27), and increases in quitting self-efficacy (OR = 1.14). Increased motivation to quit predicted conversion of a QA into quitting success at 26 weeks (OR = 1.36). Conclusion: Predictors of making a QA differed from predictors of quitting success. Predictors of QAs and success could each serve as important treatment targets of motivation-phase interventions. Implications: Motivation-phase interventions for people initially unwilling to quit smoking cigarettes may be improved by striving to increase their (1) time to first cigarette and quitting self-efficacy to promote QAs and (2) motivation to quit to promote quit success. Future experimental tests of such interventions are needed to identify causal determinants of QAs and quitting success.
Understanding long-term HIV survivorship among African American/Black and Latinx persons living with HIV in the United States: A qualitative exploration through the lens of symbolic violenceFreeman, R., Gwadz, M., Wilton, L., Collins, L. M., Dorsen, C., Hawkins, R. L., Silverman, E., Martinez, B. Y., Leonard, N. R., Applegate, A., & Cluesman, S.
Journal titleInternational Journal for Equity in Health
Issue1AbstractBackground: Persons living with HIV (PLWH) are living longer, although racial/ethnic and socioeconomic status (SES) disparities persist. Yet, little is known about the experience of living with and managing HIV over decades. The present study took a qualitative approach and used the lens of symbolic violence, a type of internalized, non-physical violence manifested in the power differential between social groups. We focused on adult African American/Black and Latinx (AABL) PLWH from low-SES backgrounds. Methods: Data were drawn from two studies with AABL PLWH in New York City (N = 59). After providing signed informed consent, participants engaged in in-depth semi-structured interviews on aspects of HIV management. Interviews were audio-recorded and professionally transcribed verbatim, and data were analyzed using directed qualitative content analysis. Results: Participants in the two studies were comparable on sociodemographic and background characteristics. They had lived with HIV for 20 years, on average (range 3-33 years). All were from low-SES backgrounds and most were African American/Black and men. Participants experienced a convergence of multiple social exclusions, harms, and stigmas, consistent with symbolic violence, which contributed to disengagement from HIV care and discontinuation of HIV medications. We organized results into five sub-themes: (1) participants were "ground down"over time by material, social, and emotional challenges and this diminished self-worth and, at times, the will to live; (2) social isolation and self-isolation, based in part on feeling devalued and dehumanized, served as stigma-avoidance strategies and mechanisms of social exclusion; (3) stigmatizing aspects of patient-provider interactions, both experienced and anticipated, along with (4) restricted autonomy in HIV care and other settings (e.g., parole) reduced engagement; and (5) poor HIV management was internalized as a personal failure. Importantly, resilience was evident throughout the five sub-themes. Conclusions: Symbolic violence is a useful framework for understanding long-term HIV management and survivorship among AABL PLWH from low-SES backgrounds. Indeed, forms of symbolic violence are internalized over time (e.g., experiencing devaluation, dehumanization, loss of self-worth, and anticipated stigma), thereby impeding successful HIV management, in part because avoiding HIV care and discontinuing HIV medications are primary coping strategies. Results have implications for interventions in community and health care settings.
Achieving the goals of translational science in public health intervention research: The multiphase optimization strategy (MOST)Guastaferro, K., & Collins, L. M.
Journal titleAmerican journal of public health
Developing a Psychological-Behavioral Intervention in Cardiac Patients Using the Multiphase Optimization Strategy: Lessons Learned from the FieldHuffman, J. C., Millstein, R. A., Celano, C. M., Healy, B. C., Park, E. R., & Collins, L. M.
Journal titleAnnals of Behavioral Medicine
Page(s)151-163AbstractBackground: The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention. Purpose: Using a 6 year MOST-based behavioral intervention development project as an example, we outline the results - and resulting decision-making process - related to experiments at each step to display the practical challenges present at each stage. Methods: To develop a positive psychology (PP) based intervention to promote physical activity after an acute coronary syndrome (N = 255 across four phases), we utilized qualitative, proof-of-concept, factorial design, and randomized pilot experiments, with iterative modification of intervention content and delivery. Results: Through this multiphase approach, we ultimately developed a 12 week, phone-delivered, combined PP-motivational interviewing intervention to promote physical activity. Across stages, we learned several important lessons: (a) participant and interventionist feedback is important, even in later optimization stages; (b) a thoughtful and systematic approach using all information sources is required when conflicting results in experiments make next steps unclear; and (3) new approaches in the field over a multiyear project should be integrated into the development process. Conclusions: A MOST-based behavioral intervention development program can be efficient and effective in developing optimized new interventions, and it may require complex and nuanced decision-making at each phase.
Effects of motivation phase intervention components on quit attempts in smokers unwilling to quit: A factorial experimentEngle, J. L., Mermelstein, R., Baker, T. B., Smith, S. S., Schlam, T. R., Piper, M. E., Jorenby, D. E., Collins, L. M., & Cook, J. W.
Journal titleDrug and alcohol dependence
Page(s)149-157AbstractBackground: Smoking reduction treatment is a promising approach to increase abstinence amongst smokers initially unwilling to quit. However, little is known about which reduction treatment elements increase quit attempts and the uptake of cessation treatment amongst such smokers. Methods: This study is a secondary analysis of a 4-factor randomized factorial experiment conducted amongst primary care patients (N = 517) presenting for regular healthcare visits in Southern Wisconsin who were unwilling to quit smoking but willing to cut down. We evaluated the main and interactive effects of Motivation-phase intervention components on whether participants: 1) made a quit attempt (intentional abstinence ≥24 h) by 6- and 26-weeks post-study enrollment and, 2) used cessation treatment. We also evaluated the relations of quit attempts with abstinence. The four intervention components evaluated were: 1) Nicotine Patch vs. None; 2) Nicotine Gum vs. None; 3) Motivational Interviewing (MI) vs. None; and 4) Behavioral Reduction Counseling (BR) vs. None. Intervention components were administered over 6 weeks, with an option to repeat treatment; participants could request cessation treatment at any point. Results: Nicotine gum significantly increased the likelihood of making a quit attempt by 6 weeks (23% vs. 15% without gum; p <.05). Conversely, nicotine patch reduced quit attempts when used with BR. Patch also discouraged use of cessation treatment (15.8% vs. 23% without patch; p <.05). Aided vs. unaided quit attempts produced abstinence in 42% vs. 10% of participants, respectively. Conclusion: Nicotine gum is a promising Motivation-phase intervention that may spur quit attempts amongst smokers initially unwilling to quit.
The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panelFailed generating bibliography.Abstract
Journal titleJournal of Clinical Epidemiology
Page(s)74-81AbstractObjectives: To provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions. Study Design and Setting: The National Institutes of Health Office of Behavioral and Social Science Research convened an expert panel to critically review the literature on control or comparison groups for behavioral trials and to develop strategies for improving comparator choices and for resolving controversies and disagreements about comparators. Results: The panel developed a Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials. The model indicates that the optimal comparator is the one that best serves the primary purpose of the trial but that the optimal comparator's limitations and barriers to its use must also be taken into account. Conclusion: We developed best practice recommendations for the selection of comparators for health-related behavioral trials. Use of the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials can improve the comparator selection process and help resolve disagreements about comparator choices.
A randomized controlled trial of an optimized smoking treatment delivered in primary carePiper, M. E., Cook, J. W., Schlam, T. R., Jorenby, D. E., Smith, S. S., Collins, L. M., Mermelstein, R., Fraser, D., Fiore, M. C., & Baker, T. B.
Journal titleAnnals of Behavioral Medicine
Page(s)854-864AbstractBackground The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence. Results A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800. Conclusions A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care. Clinical Trial Registration NCT02301403.
Healthy Campus Trial: A multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: Study protocol for a randomized controlled trialUwatoko, T., Luo, Y., Sakata, M., Kobayashi, D., Sakagami, Y., Takemoto, K., Collins, L. M., Watkins, E., Hollon, S. D., Wason, J., Noma, H., Horikoshi, M., Kawamura, T., Iwami, T., & Furukawa, T. A.
Issue1AbstractBackground: Youth in general and college life in particular are characterized by new educational, vocational, and interpersonal challenges, opportunities, and substantial stress. It is estimated that 30-50% of university students meet criteria for some mental disorder, especially depression, in any given year. The university has traditionally provided many channels to promote students' mental health, but until now only a minority have sought such help, possibly owing to lack of time and/or to stigma related to mental illness. Smartphone-delivered cognitive behavioral therapy (CBT) shows promise for its accessibility and effectiveness. However, its most effective components and for whom it is more (or less) effective are not known. Methods/design: Based on the multiphase optimization strategy framework, this study is a parallel-group, multicenter, open, fully factorial trial examining five smartphone-delivered CBT components (self-monitoring, cognitive restructuring, behavioral activation, assertion training, and problem solving) among university students with elevated distress, defined as scoring 5 or more on the Patient Health Questionnaire-9 (PHQ-9). The primary outcome is change in PHQ-9 scores from baseline to week 8. We will estimate specific efficacy of the five components and their interactions through the mixed-effects repeated-measures analysis and propose the most effective and efficacious combinations of components. Effect modification by selected baseline characteristics will be examined in exploratory analyses. Discussion: The highly efficient experimental design will allow identification of the most effective components and the most efficient combinations thereof among the five components of smartphone CBT for university students. Pragmatically, the findings will help make the most efficacious CBT package accessible to a large number of distressed university students at reduced cost; theoretically, they will shed light on the underlying mechanisms of CBT and help further advance CBT for depression.
Just-in-time adaptive interventions (JITAIs) in mobile health: Key components and design principles for ongoing health behavior supportNahum-Shani, I., Smith, S. N., Spring, B. J., Collins, L. M., Witkiewitz, K., Tewari, A., & Murphy, S. A.
Journal titleAnnals of Behavioral Medicine
Page(s)446-462AbstractBackground The just-in-time adaptive intervention (JITAI) is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual's changing internal and contextual state. The availability of increasingly powerful mobile and sensing technologies underpins the use of JITAIs to support health behavior, as in such a setting an individual's state can change rapidly, unexpectedly, and in his/her natural environment. Purpose Despite the increasing use and appeal of JITAIs, a major gap exists between the growing technological capabilities for delivering JITAIs and research on the development and evaluation of these interventions. Many JITAIs have been developed with minimal use of empirical evidence, theory, or accepted treatment guidelines. Here, we take an essential first step towards bridging this gap. Methods Building on health behavior theories and the extant literature on JITAIs, we clarify the scientific motivation for JITAIs, define their fundamental components, and highlight design principles related to these components. Examples of JITAIs from various domains of health behavior research are used for illustration. Conclusion As we enter a new era of technological capacity for delivering JITAIs, it is critical that researchers develop sophisticated and nuanced health behavior theories capable of guiding the construction of such interventions. Particular attention has to be given to better understanding the implications of providing timely and ecologically sound support for intervention adherence and retention.
Multilevel factorial designs with experiment-induced clusteringNahum-Shani, I., Dziak, J. J., & Collins, L. M.
Journal titlePsychological Methods
Page(s)458-479AbstractFactorial experimental designs have many applications in the behavioral sciences. In the context of intervention development, factorial experiments play a critical role in building and optimizing highquality, multicomponent behavioral interventions. One challenge in implementing factorial experiments in the behavioral sciences is that individuals are often clustered in social or administrative units and may be more similar to each other than to individuals in other clusters. This means that data are dependent within clusters. Power planning resources are available for factorial experiments in which the multilevel structure of the data is due to individuals' membership in groups that existed before experimentation. However, in many cases clusters are generated in the course of the study itself. Such experiment-induced clustering (EIC) requires different data analysis models and power planning resources from those available for multilevel experimental designs in which clusters exist prior to experimentation. Despite the common occurrence of both experimental designs with EIC and factorial designs, a bridge has yet to be built between EIC and factorial designs. Therefore, resources are limited or nonexistent for planning factorial experiments that involve EIC. This article seeks to bridge this gap by extending prior models for EIC, developed for single-factor experiments, to factorial experiments involving various types of EIC. We also offer power formulas to help investigators decide whether a particular experimental design involving EIC is feasible. We demonstrate that factorial experiments can be powerful and feasible even with EIC. We discuss design considerations and directions for future research.
Optimization of a technology-supported physical activity intervention for breast cancer survivors: Fit2Thrive study protocolPhillips, S. M., Collins, L. M., Penedo, F. J., Courneya, K. S., Welch, W., Cottrell, A., Lloyd, G. R., Gavin, K., Cella, D., Ackermann, R. T., Siddique, J., & Spring, B.
Journal titleContemporary Clinical Trials
Page(s)9-19AbstractFit2Thrive is a theory-guided physical activity promotion trial using the Multiphase Optimization Strategy (MOST) to test efficacy for improving physical activity of five technology-supported physical activity promotion intervention components among breast cancer survivors. This trial will recruit 256 inactive breast cancer survivors nationwide. All participants will receive the core intervention which includes a Fitbit and standard self-monitoring Fit2Thrive smartphone application which will be downloaded to their personal phone. Women will be randomized to one of 32 conditions in a factorial design involving five factors with two levels: support calls (No vs. Yes), app type (standard vs. deluxe), text messaging (No vs. Yes), online gym (No vs. Yes) and Fitbit Buddy (No vs. Yes). The proposed trial examines the effects of the components on physical activity at 12 and 24 weeks. Results will support the selection of a final package of intervention components that has been optimized to maximize physical activity and is subject to an upper limit of cost. The optimized intervention will be tested in a future trial. Fit2Thrive is the first trial to use the MOST framework to develop and test a physical activity promotion intervention in breast cancer survivors and will lead to an improved understanding of how to effectively change survivors' physical activity. These findings could result in more scalable, effective physical activity interventions for breast cancer survivors, and, ultimately, improve health and disease outcomes.
Optimizing a Positive Psychology Intervention to Promote Health Behaviors after an Acute Coronary Syndrome: The Positive Emotions after Acute Coronary Events III (PEACE-III) Randomized Factorial TrialCelano, C. M., Albanese, A. M., Millstein, R. A., Mastromauro, C. A., Chung, W. J., Campbell, K. A., Legler, S. R., Park, E. R., Healy, B. C., Collins, L. M., Januzzi, J. L., & Huffman, J. C.
Journal titlePsychosomatic Medicine
Page(s)526-534AbstractObjective Despite the clear benefits of physical activity and related behaviors on prognosis, most patients experiencing an acute coronary syndrome (ACS) remain nonadherent to these behaviors. Deficits in positive psychological constructs (e.g., optimism) are linked to reduced participation in health behaviors, supporting the potential utility of a positive psychology (PP)-based intervention in post-ACS patients. Accordingly, we aimed to identify optimal components of a PP-based intervention to promote post-ACS physical activity. Methods As part of a multiphase optimization strategy, we completed a randomized factorial trial with eight conditions in 128 post-ACS patients to efficiently identify best-performing intervention components. All participants received a PP-based intervention, with conditions varying in duration (presence/absence of booster sessions), intensity (weekly/daily PP exercises), and content (PP alone or combined with motivational interviewing), allowing three concurrent comparisons within the trial. The study aims included assessments of the overall feasibility, acceptability, and impact of the intervention, along with the primary aim of determining which components were associated with objectively measured physical activity and self-reported health behavior adherence at 16 weeks, assessed using longitudinal models. Results The intervention was well accepted and associated with substantial improvements in behavioral and psychological outcomes. Booster sessions were associated with greater activity to a nearly significant degree (β = 8.58, 95% confidence interval =-0.49-17.65, effect size difference =.43, p =.064), motivational interviewing was associated with overall adherence (β = 0.95, 95% confidence interval = 0.02-1.87, effect size difference =.39, p =.044), and weekly exercise completion was generally superior to daily. Conclusions These findings will enable optimization of the PP-based intervention in preparation for a well-powered controlled trial. Clinical Trial Registration Clinicaltrials.gov, NCT02754895.
Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization StrategyBernstein, S. L., Dziura, J., Weiss, J., Miller, T., Vickerman, K. A., Grau, L. E., Pantalon, M. V., Abroms, L., Collins, L. M., & Toll, B.
Journal titleContemporary Clinical Trials
Page(s)1-8AbstractBackground: Tobacco dependence remains the leading preventable cause of death in the developed world. Smokers are disproportionately from lower socioeconomic groups, and may use the hospital emergency department (ED) as an important source of care. A recent clinical trial demonstrated the efficacy of a multicomponent intervention to help smokers quit, but the independent contributions of those components is unknown. Methods: This is a full-factorial (16-arm) randomized trial in a busy hospital ED of 4 tobacco dependence interventions: brief motivational interviewing, nicotine replacement therapy, referral to a telephone quitline, and a texting program. The trial utilizes the Multiphase Optimization Strategy (MOST) and a novel mixed methods analytic design to assess clinical efficacy, cost effectiveness, and qualitative participant feedback. The primary endpoint is tobacco abstinence at 3 months, verified by participants' exhaled carbon monoxide. Results: Study enrollment began in February 2017. As of April 2017, 52 of 1056 planned participants (4.9%) were enrolled. Telephone-based semi-structured participant interviews and in-person biochemical verification of smoking abstinence are completed at the 3-month follow-up. Efficacy and cost effectiveness analyses will be conducted after follow-up is completed. Discussion: The goal of this study is to identify a clinically efficacious, cost-effective intervention package for the initial treatment of tobacco dependence in ED patients. The efficacy of this combination can then be tested in a subsequent confirmatory trial. Our approach incorporates qualitative feedback from study participants in evaluating which intervention components will be tested in the future trial. Trial registration: Trial (NCT02896400) registered in ClinicalTrials.gov on September 6, 2016.
An Overview of Research and Evaluation Designs for Dissemination and ImplementationBrown, C. H., Curran, G., Palinkas, L. A., Aarons, G. A., Wells, K. B., Jones, L., Collins, L. M., Duan, N., Mittman, B. S., Wallace, A., Tabak, R. G., Ducharme, L., Chambers, D. A., Neta, G., Wiley, T., Landsverk, J., Cheung, K., & Cruden, G.
Journal titleAnnual Review of Public Health
Page(s)1-22AbstractThe wide variety of dissemination and implementation designs now being used to evaluate and improve health systems and outcomes warrants review of the scope, features, and limitations of these designs. This article is one product of a design workgroup that was formed in 2013 by the National Institutes of Health to address dissemination and implementation research, and whose members represented diverse methodologic backgrounds, content focus areas, and health sectors. These experts integrated their collective knowledge on dissemination and implementation designs with searches of published evaluations strategies. This article emphasizes randomized and nonrandomized designs for the traditional translational research continuum or pipeline, which builds on existing efficacy and effectiveness trials to examine how one or more evidence-based clinicalprevention interventions are adopted, scaled up, and sustained in community or service delivery systems. We also mention other designs, including hybrid designs that combine effectiveness and implementation research, quality improvement designs for local knowledge, and designs that use simulation modeling.
Implementing Clinical Research Using Factorial Designs: A PrimerBaker, T. B., Baker, T. B., Smith, S. S., Smith, S. S., Bolt, D. M., Loh, W. Y., Mermelstein, R., Fiore, M. C., Piper, M. E., Fiore, M. C., Piper, M. E., & Collins, L. M.
Journal titleBehavior Therapy
Page(s)567-580AbstractFactorial experiments have rarely been used in the development or evaluation of clinical interventions. However, factorial designs offer advantages over randomized controlled trial designs, the latter being much more frequently used in such research. Factorial designs are highly efficient (permitting evaluation of multiple intervention components with good statistical power) and present the opportunity to detect interactions amongst intervention components. Such advantages have led methodologists to advocate for the greater use of factorial designs in research on clinical interventions (Collins, Dziak, & Li, 2009). However, researchers considering the use of such designs in clinical research face a series of choices that have consequential implications for the interpretability and value of the experimental results. These choices include: whether to use a factorial design, selection of the number and type of factors to include, how to address the compatibility of the different factors included, whether and how to avoid confounds between the type and number of interventions a participant receives, and how to interpret interactions. The use of factorial designs in clinical intervention research poses choices that differ from those typically considered in randomized clinical trial designs. However, the great information yield of the former encourages clinical researchers’ increased and careful execution of such designs.
The Positive Emotions after Acute Coronary Events behavioral health intervention: Design, rationale, and preliminary feasibility of a factorial design studyHuffman, J. C., Albanese, A. M., Campbell, K. A., Celano, C. M., Millstein, R. A., Mastromauro, C. A., Healy, B. C., Chung, W. J., Januzzi, J. L., Collins, L. M., & Park, E. R.
Journal titleClinical Trials
Page(s)128-139AbstractBackground: Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome. Objective: In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation. Methods: The Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16 weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity. Results: Thus far, 78 participants have enrolled, with 72% of all possible exercises fully completed by participants. Conclusion: The Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.
Toward precision smoking cessation treatment I: Moderator results from a factorial experimentPiper, M. E., Schlam, T. R., Cook, J. W., Smith, S. S., Bolt, D. M., Loh, W. Y., Mermelstein, R., Collins, L. M., Fiore, M. C., & Baker, T. B.
Journal titleDrug and alcohol dependence
Page(s)59-65AbstractBackground The development of tobacco use treatments that are effective for all smokers is critical to improving clinical and public health. The Multiphase Optimization Strategy (MOST) uses highly efficient factorial experiments to evaluate multiple intervention components for possible inclusion in an optimized tobacco use treatment. Factorial experiments permit analyses of the influence of patient characteristics on main and interaction effects of multiple, relatively discrete, intervention components. This study examined whether person-factor and smoking characteristics moderated the main or interactive effects of intervention components on 26-week self-reported abstinence rates. Methods This fractional factorial experiment evaluated six smoking cessation intervention components among primary care patients (N = 637): Prequit Nicotine Patch vs. None, Prequit Nicotine Gum vs. None, Preparation Counseling vs. None, Intensive Cessation In-Person Counseling vs. Minimal, Intensive Cessation Telephone Counseling vs. Minimal, and 16 vs. 8 Weeks of Combination Nicotine Replacement Therapy (NRT; nicotine patch + nicotine gum). Results Both psychiatric history and smoking heaviness moderated intervention component effects. In comparison with participants with no self-reported history of a psychiatric disorder, those with a positive history showed better response to 16- vs. 8-weeks of combination NRT, but a poorer response to counseling interventions. Also, in contrast to light smokers, heavier smokers showed a poorer response to counseling interventions. Conclusions Heavy smokers and those with psychiatric histories demonstrated a differential response to intervention components. This research illustrates the use of factorial designs to examine the interactions between person characteristics and relatively discrete intervention components. Future research is needed to replicate these findings.
Toward precision smoking cessation treatment II: Proximal effects of smoking cessation intervention components on putative mechanisms of actionPiper, M. E., Cook, J. W., Schlam, T. R., Smith, S. S., Bolt, D. M., Collins, L. M., Mermelstein, R., Fiore, M. C., & Baker, T. B.
Journal titleDrug and alcohol dependence
Page(s)50-58AbstractBackground Understanding how smoking cessation treatments exert their effects can inform treatment development and use. Factorial designs allow researchers to examine whether multiple intervention components affect hypothesized change mechanisms, and whether the affected mechanisms are related to cessation. Methods This is a secondary data analysis of smokers recruited during primary care visits (N = 637, 55% women, 87% white) who were motivated to quit. Participants in this fractional factorial experiment were randomized to one level of each of six intervention factors: Prequit Nicotine Patch vs None, Prequit Nicotine Gum vs None, Preparation Counseling vs None, Intensive In-Person Counseling vs Minimal, Intensive Phone Counseling vs Minimal, and 16 vs 8 Weeks of Combination Nicotine Replacement (nicotine patch + nicotine gum). Data on putative mechanisms (e.g., medication use, withdrawal, self-efficacy) and smoking status were gathered using daily assessments and during follow-up assessment calls. Results Some intervention components influenced hypothesized mechanisms. Prequit Gum and Patch each reduced prequit smoking and enhanced prequit coping and self-efficacy. In-Person Counseling increased prequit motivation to quit, postquit self-efficacy, and postquit perceived intratreatment support. Withdrawal reduction and reduced prequit smoking produced the strongest effects on cessation. The significant effect of combining Prequit Gum and In-Person Counseling on 26-week abstinence was mediated by increased prequit self-efficacy. Conclusions This factorial experiment identified which putative treatment mechanisms were influenced by discrete intervention components and which mechanisms influenced cessation. Such information supports the combined use of prequit nicotine gum and intensive in-person counseling as cessation interventions that operate via increased prequit self-efficacy.