Is it worth it? Greater risk aversion with lower life satisfaction among depressed individuals.

Decisions of individuals with depression are often risk-averse. Risk-aversion may also extend to decisions regarding treatment, which may cause individuals to forgo or delay treatment. It is also well established that depression is associated with lower satisfaction with life. However, whether life satisfaction is associated with risk aversion for individuals with depression is not yet known. Three groups of participants (Depressed: n = 61; Chronic pain: n = 61; Comorbid depression and pain: n = 58) completed a clinical interview and several self-report questionnaires, including the Satisfaction with Life Scale (SWLS). Participants also completed two utility elicitation tasks: time trade-off (TTO), which measures utilities of health states without implied risks, and standard gamble (SG), which measures utilities of health states in the presence of risk (presented in this study as a hypothetical clinical trial described as having both potential harms and benefits). Risk aversion is defined as the difference in the utility ratings generated via SG and via TTO. For both TTO and SG, individuals evaluated their own depression or pain. When perfect health was used as a hypothetical benefit in TTO and SG tasks, satisfaction with life was not associated with risk preferences, for either depressed participants or participants with chronic pain (all ps ns). However, for participants with depression, when the hypothetical benefit was a more ecologically valid 'mild' depression in TTO and SG tasks, lower satisfaction with life was associated with greater risk aversion (p < .005; p < .03). For depressed individuals, therefore, lower satisfaction with life may be associated with risk aversion regarding treatments when benefits are seen as minor, which may result in treatment avoidance and, consequently, further worsening of both symptoms and life satisfaction.

Suicidality in the Arab World: Results from an Online Screener.

Suicide in the Arab World is grossly understudied. This study sought to understand suicidality among Arabic-speaking individuals visiting an online depression screener. A large sample (N = 23,201) from the Arab World was recruited online. 78.9% (n = 17,042) reported suicidality (thoughts of death or suicide, or a suicide attempt) and 12.4% reported a suicide attempt in the past 2 weeks. Binary logistic regressions indicated that women tended to report more suicidality, and that suicidality tended to decline with age (all ps < 0.001), across all levels of suicidality. Comparing countries with n ≥ 1000 (Algeria, Egypt, Jordan, Morocco, and Saudi Arabia), several 3-way (gender * age * country) and 2-way interactions indicated that some countries departed from the usual pattern of responses. For instance, in Algeria, neither gender nor age differences were observed in reported attempts. Women and younger adults in the Arab World may be at higher risk of suicidality. Differences between and within countries warrant further exploration.

Self-harm behaviors and their intentions: a cross-cultural analysis.

BACKGROUND: Self-harm behaviors (performed with either lethal and non-lethal intentions) are common, especially among individuals suffering from mood disorders, and the reasons individuals self-harm vary both by person and by the type of behavior. Understanding these variations may help clinicians determine levels of risk more accurately. AIMS: To understand whether culture and gender are associated with the likelihood of engaging in specific self-harm behaviors and whether the intention (lethal, ambivalent, non-lethal) of these behaviors vary with culture and gender. METHODS: 2826 individuals took part in an international multilingual online depression/suicidality screening study and reported at least one instance of self-harm in the past year. Participants were grouped into six broad cultural categories (Latin America, South Asia, Russian, Western English, Chinese, Arab). RESULTS: 3-way (culture x gender x intent) interactions were observed for several self-harm behaviors (overdosing, self-burning, asphyxiating, poisoning, and jumping from heights), suggesting that individuals engage in each of these behaviors with different intentions depending on gender and culture. Cultures and genders likewise differed in the likelihood of engaging in several self-harm behaviors. CONCLUSIONS: Clinicians should consider culture and gender when assessing for suicide risk, as similar self-harming behaviors may reflect different intentions depending on an individual's culture and gender.

Role of Maternal Depression on Child Development: A Prospective Analysis from Pregnancy to Early Childhood.

Few studies have examined how different characteristics of maternal depression may be associated with developmental outcomes among low-income children. The current study prospectively examined whether the timing (pregnancy vs. early postpartum), severity, and chronicity of maternal depression were associated with child cognitive and social-emotional development in two cohorts of primarily low-income Latinx immigrant mothers and their children. Maternal depression was assessed during pregnancy and at 6 months postpartum. Child development was assessed up to 5 years postpartum. Results showed that maternal depression experienced during pregnancy was associated with lower child cognitive development, particularly among girls. Additionally, both the timing (pregnancy and early postpartum) and severity/chronicity of maternal depression were each independently associated with lower child social-emotional development. These findings highlight the need for early prevention interventions to help offset the adverse effects of maternal depression on child developmental outcomes in this at-risk population.

Longitudinal Association Between Smoking Abstinence and Depression Severity in Those With Baseline Current, Past, and No History of Major Depressive Episode in an International Online Tobacco Cessation Study.

INTRODUCTION: We use multilevel modeling to parse out the effects of time-varying smoking abstinence and baseline depression (history and severity) on depression severity over 1 year. AIMS AND METHODS: Participants were 1000 smokers recruited worldwide for an online randomized controlled tobacco cessation trial. We examined whether changes in depression severity over time were associated with self-reported 7-day point prevalence smoking status assessed at 1-, 3-, 6-, and 12-month follow-up (FU) using baseline major depressive episode (MDE) history and baseline depression severity as time-invariant covariates. We present depression severity means and smoking abstinence at each FU. RESULTS: Regardless of concurrent abstinence status, baseline MDE history was significantly related to depression severity over time: those reporting a past MDE had worse depressive symptoms over time compared with those reporting no MDE history. Baseline depression severity interacted significantly with time-varying abstinence status: for every 1-unit increase in baseline scores on the Center for Epidemiological Studies-Depression Scale (CES-D), individuals who were smoking at FU reported CES-D scores that were 0.17 points higher than those who were abstinent. In this context, nicotine dependence, gender, age, or marital status did not affect depression severity. CONCLUSIONS: In the context of cessation, having an MDE history plays a significant role in the trajectory of depression severity over the course of 1 year, regardless of abstinence status. Abstinence is related to lower depressive symptoms at each FU, and this effect was stronger at higher levels of baseline depression severity. IMPLICATIONS: This study indicates that depressive symptoms are not exacerbated among individuals who are quitting smoking at 1-, 3-, 6-, and 12-month FUs. Depression severity is worse with a baseline history of MDE. Further, those with high baseline depression severity who continue smoking have worse depressive symptoms throughout a 1-year period compared with their abstinent counterparts.

Leading the charge toward a world without depression: perinatal depression can be prevented.

This manuscript is based on a keynote address presented at the 2020 Marcé Society's Conference celebrating the Society's 40th anniversary. The address described a 50-year perspective on prevention research, current evidence that perinatal depression can be prevented, and how digital tools could be used to disseminate perinatal depression prevention interventions throughout the world. We utilized the Mothers and Babies Course as a case study to illustrate these goals. The article reviews the gradual progress of depression prevention research, from the time when the state of the science was such that it was believed that the onset of major depressive episodes could not be prevented until the present day. In addition, the article recounts the three consensus reports on prevention of mental disorders published by the National Academies of Science, Engineering, and Medicine, culminating in the 2019 report, which calls on the field to implement known interventions for the prevention of depression and other mental disorders, and to scale up their administration to reduce the prevalence of these disorders in the general population. The paper presents the 2019 recommendations of the US Preventive Services Task Force, which instructs the health system to provide routine referrals to perinatal depression prevention interventions (e.g., the Mothers and Babies Course) to perinatal persons at risk for depression. We now have the knowledge to prevent approximately half of episodes of perinatal depression. It is time to implement this knowledge and begin to do research on how to prevent the remaining half.

A proof-of-concept pilot randomized comparative trial of brief Internet-based compassionate mind training and cognitive-behavioral therapy for perinatal and intending to become pregnant women.

OBJECTIVE: Depression is a prevalent and costly mental health problem that affects women as well as their larger communities, with substantial impacts on mother and infant during childbearing years. Face-to-face care has not adequately addressed this global concern due to difficulties in scaling these resources. Internet interventions, which can provide psychological tools to those lacking adequate access, show promise in filling this void. METHOD: We conducted a 2-condition proof-of-concept pilot randomized trial comparing brief Internet-based cognitive behavioural therapy (CBT) and brief Internet-based compassionate mind training (CMT) for women who are currently pregnant, became pregnant within the last year, and intend to become pregnant in the future. RESULTS: We found that, although CMT and CBT demonstrated near equivalence in improving affect, self-reassurance, self-criticism, and self-compassion, CMT showed superiority to CBT in reducing depression and anxiety symptoms. CONCLUSION: These findings provide a compelling initial argument for the use of CMT as an avenue for addressing problems associated with negative affect. Implications, limitations, and future directions along this line of research will also be discussed.

Preventing Perinatal Depression in High Risk Women: Moving the Mothers and Babies Course from Clinical Trials to Community Implementation.

A growing research literature highlights the public health need for preventive interventions to reduce symptoms and incidence of perinatal depression among vulnerable populations. The Mothers and Babies (MB) course is a cognitive-behavioral intervention designed to teach mood regulation skills to English- and Spanish-speaking low-income women at high risk for perinatal depression. We describe the development of the MB course and evaluate the extent to which research findings support efficacy, effectiveness, and dissemination based on the Society for Prevention Research Standards Committee's standards of evidence. Our review of research and implementation activities suggests that the MB intervention demonstrates promising evidence for efficacy in reducing depressive symptoms; empirical support for prevention of major depressive episodes is still preliminary. Work is in progress to evaluate program effectiveness and prepare for broad dissemination and implementation. The MB course shows promise as an intervention for low-income women at risk for perinatal mood issues. Spanish and English intervention materials have been developed that can be delivered in different settings (hospitals, home visiting), in different dosages (6, 8, or 12 sessions), and via different modalities (group, individual). Evaluating the MB course against current standards is intended to inform other prevention intervention development research.

Smoking cessation outcomes among sexual and gender minority and nonminority smokers in extended smoking treatments.

INTRODUCTION: Sexual and gender minority individuals (i.e., lesbian, gay, bisexual, and transgender [LGBT]) have a higher smoking prevalence than nonminority individuals. There is limited evidence of smoking abstinence success in nontailored smoking treatments among LGBT smokers. METHODS: This study is a secondary data analysis comparing the efficacy of extended, nontailored treatments among sexual and gender minority and nonminority smokers. Data from two clinical trials were combined to increase power and generalizability of the findings. Trials began with 12 weeks of counseling, nicotine replacement, and bupropion, after which participants were randomized to an extended treatment. RESULTS: Follow-up occurred at weeks 12, 24, 52, 64, and 104. Of the sample (n = 777), 17% identified as sexual and gender minority and 83% as nonminority. The sample was 75% non-Hispanic White, with 86% completing at least some college, and 68% were employed. Sexual and gender minorities were younger and indicated a greater desire to quit smoking than nonminority smokers. No other differences emerged on demographic, smoking, or mood variables. The average Fagerström Test for Nicotine Dependence score was 4.8, and mean daily cigarettes was 19.8. The generalized estimating equations model revealed no significant differences in abstinence between sexual and gender minority smokers and nonminority smokers at all follow-up assessments. CONCLUSIONS: Sexual and gender minority smokers appear as likely to quit or abstain as nonminority smokers in extended, nontailored interventions. However, these findings may not generalize to other geographic areas, where access to treatment is limited or a higher stigma of sexual orientation exists.

Keywords to recruit Spanish- and English-speaking participants: evidence from an online postpartum depression randomized controlled trial.

BACKGROUND: One of the advantages of Internet-based research is the ability to efficiently recruit large, diverse samples of international participants. Currently, there is a dearth of information on the behind-the-scenes process to setting up successful online recruitment tools. OBJECTIVE: The objective of the study was to examine the comparative impact of Spanish- and English-language keywords for a Google AdWords campaign to recruit pregnant women to an Internet intervention and to describe the characteristics of those who enrolled in the trial. METHODS: Spanish- and English-language Google AdWords campaigns were created to advertise and recruit pregnant women to a Web-based randomized controlled trial for the prevention of postpartum depression, the Mothers and Babies/Mamás y Bebés Internet Project. Search engine users who clicked on the ads in response to keyword queries (eg, pregnancy, depression and pregnancy) were directed to the fully automated study website. Data on the performance of keywords associated with each Google ad reflect Web user queries from February 2009 to June 2012. Demographic information, self-reported depression symptom scores, major depressive episode status, and Internet use data were collected from enrolled participants before randomization in the intervention study. RESULTS: The Google ads received high exposure (12,983,196 impressions) and interest (176,295 clicks) from a global sample of Web users; 6745 pregnant women consented to participate and 2575 completed enrollment in the intervention study. Keywords that were descriptive of pregnancy and distress or pregnancy and health resulted in higher consent and enrollment rates (i.e., high-performing ads). In both languages, broad keywords (eg, pregnancy) had the highest exposure, more consented participants, and greatest cost per consent (up to US $25.77 per consent). The online ads recruited a predominantly Spanish-speaking sample from Latin America of Mestizo racial identity. The English-speaking sample was also diverse with most participants residing in regions of Asia and Africa. Spanish-speaking participants were significantly more likely to be of Latino ethnic background, not married, completed fewer years of formal education, and were more likely to have accessed the Internet for depression information (P<.001). CONCLUSIONS: The Internet is an effective method for reaching an international sample of pregnant women interested in online interventions to manage changes in their mood during the perinatal period. To increase efficiency, Internet advertisements need to be monitored and tailored to reflect the target population's conceptualization of health issues being studied. TRIAL REGISTRATION: ClinicalTrials.gov NCT00816725; http://clinicaltrials.gov/show/NCT00816725 (Archived by WebCite at http://www.webcitation.org/6LumonjZP).

Using Google AdWords for international multilingual recruitment to health research websites.

BACKGROUND: Google AdWords, the placement of sponsored links in Google search results, is a potent method of recruitment to Internet-based health studies and interventions. However, the performance of Google AdWords varies considerably depending on the language and the location of the target audience. OBJECTIVE: Our goal was to describe differences in AdWords performance when recruiting participants to the same study conducted in four languages and to determine whether AdWords campaigns can be optimized in order to increase recruitment while decreasing costs. METHODS: Google AdWords were used to recruit participants to the Mood Screener, a multilingual online depression screening tool available in English, Russian, Spanish, and Chinese. Two distinct recruitment periods are described: (1) "Unmanaged", a 6-month period in which ads were allowed to run using only the AdWords tool itself, with no human intervention, and (2) "Managed", a separate 7-week period during which we systematically sought to optimize our recruitment campaigns. RESULTS: During 6 months of unmanaged recruitment, our ads were shown over 1.3 million times, resulting in over 60,000 site visits. The average click-through rate (ratio of ads clicked to ads displayed) varied from 1.86% for Chinese ads to 8.48% for Russian ads, as did the average cost-per-click (from US $0.20 for Chinese ads to US $0.50 for English ads). Although Chinese speakers' click-through rate was lowest, their rate of consenting to participate was the highest, at 3.62%, with English speakers exhibiting the lowest consent rate (0.97%). The conversion cost (cost to recruit a consenting participant) varied from US $10.80 for Russian speakers to US $51.88 for English speakers. During the 7 weeks of "managed" recruitment, we attempted to improve AdWords' performance in regards to the consent rate and cost by systematically deleting underperforming ads and adjusting keywords. We were able to increase the number of people who consent after coming to the site by 91.8% while also decreasing per-consent cost by 23.3%. CONCLUSIONS: Our results illustrate the need to linguistically and culturally adapt Google AdWords campaigns and to manage them carefully to ensure the most cost-effective results.

Suicide attempts in the absence of depression: Differences between broad cultural groups.

Suicide is one of the leading causes of death worldwide (WHO, 2021). Depression is a common precursor to suicide and suicidality; however, individuals' experience of depression and the meaning of suicide differs depending on one's cultural background (Colucci, 2013; Goodmann et al., 2021; Kleinman, 2004). The current study explores the relationship between suicide and depression among six broad cultural groups in a large sample (N = 17,015) of adults representing six broad cultural groups (Latin America, South Asia, former Soviet Bloc, Western English-speakers, Chinese, and Arab World). Participants were recruited to a multilingual depression and suicide screening study via Google Ads (Leykin et al., 2012; Gross et al., 2014). As expected, the presence of depression was associated with suicide attempts. However, cultural group moderated this association, with Chinese participants being most likely to report suicide attempts while screening negative for depression. Although depression remains an important predictor of suicidality, it appears that certain cultural groups may be at higher risk even when depression is not present. Clinicians should consider using culturally adapted assessments for depression and suicidality.

Understanding attrition from international Internet health interventions: a step towards global eHealth.

Worldwide automated Internet health interventions have the potential to greatly reduce health disparities. High attrition from automated Internet interventions is ubiquitous, and presents a challenge in the evaluation of their effectiveness. Our objective was to evaluate variables hypothesized to be related to attrition, by modeling predictors of attrition in a secondary data analysis of two cohorts of an international, dual language (English and Spanish) Internet smoking cessation intervention. The two cohorts were identical except for the approach to follow-up (FU): one cohort employed only fully automated FU (n = 16 430), while the other cohort also used 'live' contact conditional upon initial non-response (n = 1000). Attrition rates were 48.1 and 10.8% for the automated FU and live FU cohorts, respectively. Significant attrition predictors in the automated FU cohort included higher levels of nicotine dependency, lower education, lower quitting confidence and receiving more contact emails. Participants' younger age was the sole predictor of attrition in the live FU cohort. While research on large-scale deployment of Internet interventions is at an early stage, this study demonstrates that differences in attrition from trials on this scale are (i) systematic and predictable and (ii) can largely be eliminated by live FU efforts. In fully automated trials, targeting the predictors we identify may reduce attrition, a necessary precursor to effective behavioral Internet interventions that can be accessed globally.

Training Addiction Counselors to Implement an Evidence-Based Intervention: Strategies for Increasing Organizational and Provider Acceptance.

One barrier to widespread public access to empirically supported treatments (ESTs) is the limited availability and high cost of professionals trained to deliver them. Our earlier work from two clinical trials demonstrated that front-line addiction counselors could be trained to deliver a manualized, group-based cognitive behavioral therapy (GCBT) for depression, a prototypic example of an EST, with a high level of adherence and competence. This follow-up article provides specific recommendations for the selection and initial training of counselors, and for the structure and process of their ongoing clinical supervision. Unique challenges in working with counselors unaccustomed to traditional clinical supervision are highlighted. The recommendations are based on comprehensive feedback derived from clinician notes taken throughout the clinical trials, a focus group with counselors conducted one year following implementation, and interviews with key organization executives and administrators.

Updated taxonomy of digital mental health interventions: a conceptual framework.

Most individuals at risk for or already experiencing mental disorders have no access to mental health care. Digital mental health interventions (DMHIs) can be effective in preventing and treating mental disorders. A taxonomy of digital interventions was previously proposed to organize the different types of digital tools being developed to expand mental health service delivery. This article updates that framework and presents illustrations for four types of digital interventions specific to mental health and revises their definitions. The illustrations primarily focus on studies that include populations underrepresented in the literature to highlight the potential of DMHIs to reduce health disparities. Provider administered DMHIs (Type 1) and provider administered DMHIs with blended digital adjuncts (Type 2) are offered within a healthcare system. Self-help human supported/guided DMHIs with therapeutic or technical guidance (Type 3) are offered outside a healthcare system. And self-help fully automated DMHIs (Type 4) are interventions similar to self-help books, do not involve human support and are also offered outside a healthcare system. Type 1, 2, and 3 interventions are consumable, they require human time to administer and are limited by the number of hours a health care provider or guide (to promote adherence) is available. Type 4 interventions are non-consumable because these can be used an unlimited number of times anytime anywhere in the world without human interaction. Identifying DMHIs as belonging to one of these categories can promote the development of each category, guide future reviews and help disseminate those DMHIs to as many people as possible.

Discrepancies in suicide screenings: Results from an international study.

BACKGROUND: When screening for suicidality, clinicians usually ask questions in ascending order of severity. Clinicians often discontinue questioning after negative responses to the first question or questions, presuming that these individuals are unlikely to endorse any further suicidality. In this study, the accuracy of this presumption is evaluated in a large international sample. METHODS: Participants were 21,385 individuals reporting a suicide attempt in the past two weeks. Participants were recruited, primarily via Google Ads, to a quintilingual (English, Spanish, Chinese, Arabic, and Russian) multinational depression and suicide screening study. RESULTS: Examining three initial screening questions (i.e., thoughts of death, wanting to die, and thinking about committing suicide), 14.8 % (n = 3179) of participants denied one or more question, 3.96 % (n = 847) denied two, and 1.95 % (n = 416) denied all three questions. The proportions of individuals with discrepant responses differed between linguistic-geographical groups, with Chinese and South Asian groups being more likely to be discrepant across all questions (all ps < .001). LIMITATIONS: Suicidality was assessed using an internet-based self-report measure, and linguistic-geographical groups explored in this study are very broad, which may limit generalizability. CONCLUSIONS: Results suggest that prematurely discontinuing suicide screening may fail to capture some individuals who made a recent attempt, and that in some groups, this discrepancy may be more pronounced. Clinicians should assess all individuals as thoroughly as possible regardless of initial responses, inquire about other significant risk factors, and be culturally sensitive.

Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations.

OBJECTIVE: Too few cancer patients and survivors receive evidence-based interventions for mental health symptoms. This review examines the potential for Internet interventions to help fill treatment gaps in psychosocial oncology and presents evidence regarding the likely utility of Internet interventions for cancer patients. METHODS: The authors examined available literature regarding Internet interventions tailored to cancer patients' mental health needs and reviewed elements of Internet interventions for mental health relevant to advancing psycho-oncology Internet intervention research. RESULTS: Few rigorous studies focusing on mental health of cancer patients have been conducted online. A growing body of evidence supports the efficacy, accessibility, and acceptability of mental health Internet interventions for a variety of general and medical patient populations. The authors present recommendations and guidelines to assist researchers in developing, testing, and disseminating Internet interventions for cancer patients and survivors, to manage and improve their mental health. Issues unique to Internet interventions-including intervention structure, customization, provider interaction, and privacy and confidentiality issues-are discussed. These guidelines are offered as a step toward establishing a set of "best practices" for Internet interventions in psycho-oncology and to generate further discussion regarding the goals of such interventions and their place in cancer care. CONCLUSIONS: Internet interventions have the potential to fill an important gap in quality cancer care by augmenting limited available mental health services. These interventions should be developed in a manner consistent with best practices and must be empirically tested and validated. Copyright © 2011 John Wiley & Sons, Ltd.

Are consumers of Internet health information "cyberchondriacs"? Characteristics of 24,965 users of a depression screening site.

BACKGROUND: The number of individuals looking for health information on the Internet continues to expand. The purpose of this study was to understand the prevalence of major depression among English-speaking individuals worldwide looking for information on depression online. METHODS: An automated online Mood Screener website was created and advertised via Google AdWords, for 1 year. Participants (N = 24,965) completed a depression screening measure and received feedback based on their results. Participants were then invited to participate in a longitudinal mood screening study. RESULTS: Of the 24,965 who completed the screening, 66.6% screened positive for current major depression, 44.4% indicated current suicidality, and 7.8% reported a recent (past 2 weeks) suicide attempt. Of those consenting to participate in the longitudinal study (n = 1,327 from 86 countries), 77.4% screened positive for past depression, 64.6% reported past suicidality, and 17.5% past suicide attempt. Yet, only 25% of those screening positive for current depression, and only 37.2% of those reporting a recent suicide attempt are in treatment. CONCLUSION: Many of the consumers of Internet health information may genuinely need treatment and are not "cyberchondriacs." Online screening, treatment, and prevention efforts may have the potential to serve many currently untreated clinically depressed and suicidal individuals.

Interpreting the outcomes of automated internet-based randomized trials: example of an International Smoking Cessation Study.

BACKGROUND: Smoking is one of the largest contributors to the global burden of disease. Internet interventions have been shown to reduce smoking rates successfully. However, improved methods of evaluating effectiveness need to be developed for large-scale Internet intervention trials. OBJECTIVE: To illustrate a method to interpret outcomes of large-scale, fully automated, worldwide Internet intervention trials. METHODS: A fully automated, international, Internet-based smoking cessation randomized controlled trial was conducted in Spanish and English, with 16,430 smokers from 165 countries. The randomized controlled trial replicated a published efficacy trial in which, to reduce follow-up attrition, 1000 smokers were followed up by phone if they did not provide online follow-up data. RESULTS: The 7-day self-reported abstinence rates ranged from 36.18% (2239/6189) at 1 month to 41.34% (1361/3292) at 12 months based on observed data. Given high rates of attrition in this fully automated trial, when participants unreachable at follow-up were presumed to be smoking, the abstinence rates ranged from 13.63% (2239/16.430) at 1 month to 8.28% (1361/16,430) at 12 months. We address the problem of interpreting results with high follow-up attrition rates and propose a solution based on a smaller study with intensive phone follow-up. CONCLUSIONS: Internet-based smoking cessation interventions can help large numbers of smokers quit. Large-scale international outcome studies can be successfully implemented using automated Internet sites. Interpretation of the studies' results can be aided by extrapolating from results obtained from subsamples that are followed up by phone or similar cohort maintenance methods. TRIAL REGISTRATION: ClinicalTrials.gov NCT00721786; http://clinicaltrials.gov/ct2/show/NCT00721786 (Archived by WebCite at http://www.webcitation.org/63mhoXYPw).