Trial of a patient-directed eHealth program to ameliorate perinatal depression: the MomMoodBooster2 practical effectiveness study.

BACKGROUND: Depression is one of the most common complications of childbirth, and is experienced by approximately 17% of pregnant women and 13% of postpartum women. An estimated 85% of these women go untreated-an alarming statistic given the serious consequences for the mother, her child, other family members, and society. Professional societies (the American College of Obstetricians and Gynecologists and American Academy of Pediatrics) have recommended improvements in screening and treatment. Meta-analyses indicate that cognitive behavioral therapy eHealth interventions are efficacious for depression, generally, and for perinatal depression, specifically. Earlier controlled trials have established the effectiveness and acceptability of MomMoodBooster (including an Australian version, MumMoodBooster), an eHealth program for ameliorating postpartum depression. OBJECTIVE: This study aimed to evaluate the effectiveness of a perinatal version of MomMoodBooster encompassing both prenatal and postpartum content in a healthcare delivery setting already providing universal screening and referral of at-risk patients as part of routine care. STUDY DESIGN: A practical effectiveness study randomly assigned 95 pregnant and 96 postpartum women screened as depressed and satisfying eligibility criteria to experimental groups: the healthcare organization's perinatal depression care program (routine-care group) and routine care+MomMoodBooster2 program (eHealth group). Eligibility criteria included: pregnant or <1 year postpartum, ≥18 years of age, no active suicidal ideation, access to broadband internet via desktop/laptop, tablet, or smartphone, and English language proficiency. RESULTS: Intent-to-treat analyses of group effects used fixed-effects growth models to assess 12-week posttest change in outcomes. Results showed that both groups had significantly decreased depression severity, anxiety, stress, and automatic thoughts, and increased behavioral activation and self-efficacy. Relative to the routine-care group, the eHealth group displayed significantly greater decreases in depression severity and stress. These group comparisons were not moderated by depression severity (screening or baseline), anxiety, stress, or pregnant/postpartum status. Almost all (93%; n=89) women in the eHealth group visited their program, of whom 99% visited program sessions (M sessions visited=4.3±2.0; M total session duration=73.0±70.2 minutes; 49% viewed all 6 sessions). Among confirmed eHealth program users who provided ratings, 96% (79/82) rated their program as easy to use, 83% rated it helpful, and 93% (76/82) indicated that they would recommend it. CONCLUSION: Results support the effectiveness of using MomMoodBooster2 as a treatment option for perinatal women with depression, especially when combined with universal depression screening and referral. Consequently, the eHealth program shows promise as a tool to increase the reach of treatment delivery and to potentially reduce the number of untreated perinatal women with depression.

Internet and Face-to-face Cognitive Behavioral Therapy for Postnatal Depression Compared With Treatment as Usual: Randomized Controlled Trial of MumMoodBooster.

BACKGROUND: Previous research has confirmed that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. Advantages of internet-delivered treatment include anonymity, convenience, and catering to women who are unable to access face-to-face (FTF) treatments. To date, no research has examined the efficacy of such interventions compared directly with FTF treatments in women clinically diagnosed with PND. OBJECTIVE: This study aims to compare the efficacy of one of the first web-based cognitive behavioral therapy (CBT) interventions (internet CBT+coach calls) for PND (MumMoodBooster [MMB]) with FTF-CBT in a randomized controlled trial (RCT). METHODS: In this study, 116 postnatal women with a Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) diagnosis of major or minor depression were randomized to MMB (39/116, 33.6%), FTF-CBT (39/116, 33.6%), or a treatment-as-usual (TAU) control condition (38/116, 32.8%). Diagnostic status was determined at baseline and at 21-week follow-up using the Structured Clinical Interview for the DSM-IV. Severity of anxiety and depressive symptoms was evaluated using the Depression Anxiety Stress Scales and the revised Beck Depression Inventory at baseline, 12-week follow-up (after treatment), and 21-week follow-up. RESULTS: Of the 116 participants, 107 (92.2%) had a diagnosis of major depression at baseline. Rates of remission from a major or minor depressive episode at 21 weeks in both the FTF-CBT and MMB groups were superior to that of the TAU group (56.6% and 47.7% less likely to be depressed, respectively) and they were not significantly different from each other. Although remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety, and stress from baseline to the 21-week follow-up (large and moderate effect sizes). Thus, after 21 weeks, the average symptom scores for depression and anxiety of women receiving MMB were approximately half those of women in both the TAU and FTF-CBT groups. CONCLUSIONS: In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed PND episode. MMB was superior to TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over the 21-week follow-up for depressed postnatal women. These findings replicate results of prior studies on MMB that showed clinically significant improvements in depressive symptoms, and they provide direct empirical support that internet-delivered treatment for depressed postnatal women is a viable alternative to FTF treatment. The generalizability of the results needs to be examined in future research, as RCTs of internet-based versus FTF treatments necessarily involve a subset of people who are willing to undertake either modality of treatment. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000881730; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true.

Evaluating the efficacy of the Family Check-Up Online: A school-based, eHealth model for the prevention of problem behavior during the middle school years.

This study evaluated the efficacy of a family-centered preventive intervention, the Family Check-Up (FCU), delivered as an online, eHealth model to middle school families. To increase accessibility of family-centered prevention in schools, we adapted the evidence-based FCU to an online format, with the goal of providing a model of service delivery that is feasible, given limited staffing and resources in many schools. Building on prior research, we randomly assigned participants to waitlist control (n = 105), FCU Online as a web-based intervention (n = 109), and FCU Online with coaching support (n = 108). We tested the effects of the intervention on multiple outcomes, including parental self-efficacy, child self-regulation, and child behavior, in this registered clinical trial (NCT03060291). Families engaged in the intervention at a high rate (72% completed the FCU assessment) and completed 3-month posttest assessments with good retention (94% retained). Random assignment to the FCU Online with coaching support was associated with reduced emotional problems for children (p = .003, d = -0.32) and improved parental confidence and self-efficacy (p = .018, d = 0.25) when compared with waitlist controls. Risk moderated effects: at-risk youth showed stronger effects than did those with minimal risk. The results have implications for online delivery of family-centered interventions in schools.

Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial.

BACKGROUND: Many best practice smoking cessation programs use fully automated internet interventions designed for nonmobile personal computers (desktop computers, laptops, and tablets). A relatively small number of smoking cessation interventions have been designed specifically for mobile devices such as smartphones. OBJECTIVE: This study examined the efficacy and usage patterns of two internet-based best practices smoking cessation interventions. METHODS: Overall, 1271 smokers who wanted to quit were randomly assigned to (1) MobileQuit (designed for-and constrained its use to-mobile devices, included text messaging, and embodied tunnel information architecture) or (2) QuitOnline (designed for nonmobile desktop or tablet computers, did not include text messages, and used a flexible hybrid matrix-hierarchical information architecture). Primary outcomes included self-reported 7-day point-prevalence smoking abstinence at 3- and 6-month follow-up assessments. Program visits were unobtrusively assessed (frequency, duration, and device used for access). RESULTS: Significantly more MobileQuit participants than QuitOnline participants reported quitting smoking. Abstinence rates using intention-to-treat analysis were 20.7% (131/633) vs 11.4% (73/638) at 3 months, 24.6% (156/633) vs 19.3% (123/638) at 6 months, and 15.8% (100/633) vs 8.8% (56/638) for both 3 and 6 months. Using Complete Cases, MobileQuit's advantage was significant at 3 months (45.6% [131/287] vs 28.4% [73/257]) and the combined 3 and 6 months (40.5% [100/247] vs 25.9% [56/216]) but not at 6 months (43.5% [156/359] vs 34.4% [123/329]). Participants in both conditions reported their program was usable and helpful. MobileQuit participants visited their program 5 times more frequently than did QuitOnline participants. Consistent with the MobileQuit's built-in constraint, 89.46% (8820/9859) of its visits were made on an intended mobile device, whereas 47.72% (691/1448) of visits to QuitOnline used an intended nonmobile device. Among MobileQuit participants, 76.0% (459/604) used only an intended mobile device, 23.0% (139/604) used both mobile and nonmobile devices, and 0.1% (6/604) used only a nonmobile device. Among QuitOnline participants, 31.3% (137/438) used only the intended nonmobile devices, 16.7% (73/438) used both mobile and nonmobile devices, and 52.1% (228/438) used only mobile devices (primarily smartphones). CONCLUSIONS: This study provides evidence for optimizing intervention design for smartphones over a usual care internet approach in which interventions are designed primarily for use on nonmobile devices such as desktop computers, laptops. or tablets. We propose that future internet interventions should be designed for use on all of the devices (multiple screens) that users prefer. We forecast that the approach of designing internet interventions for mobile vs nonmobile devices will be replaced by internet interventions that use a single Web app designed to be responsive (adapt to different screen sizes and operating systems), share user data across devices, embody a pervasive information architecture, and complemented by text message notifications. TRIAL REGISTRATION: ClinicalTrials.gov NCT01952236; https://clinicaltrials.gov/ct2/show/NCT01952236 (Archived by WebCite at http://www.webcitation.org/6zdSxqbf8).

The Family Check-Up Online Program for Parents of Middle School Students: Protocol for a Randomized Controlled Trial.

BACKGROUND: Research has established that skillful family management during adolescence protects youth from a variety of mental health and behavioral problems. Interventions associated with this research have focused on parenting skills as the mediator that links early risk factors with a profile of later behavioral risk, including problem behavior, substance use, and school failure. Fortunately, positive changes in family management skills have been linked to meaningful improvements in adolescent behavior, and these improvements have been significant across a variety of cultural groups. OBJECTIVE: We describe the background, research design, and intervention components of an electronic health version of the Family Check-Up program that is targeting middle school children and is being evaluated in a randomized controlled trial for its usability, feasibility, and efficacy. METHODS: We used an iterative formative research process to develop an electronic health version of the Family Check-Up program. In our ongoing randomized controlled trial, eligible families are randomly assigned to 1 of 3 conditions: Family Check-Up Online-only (n≈100), Family Check-Up Online + Coach (n≈100), and a waitlist control condition (middle school as usual; n≈100). We are conducting assessments at baseline, 3 months following randomization (posttest), and at follow-ups scheduled for 6 months and 12 months. RESULTS: This randomized controlled trial project was funded in 2015. Participant recruitment was completed in spring 2018 and enrollment is ongoing. Follow-up assessments will be completed in 2019. CONCLUSIONS: The innovative Family Check-Up Online program has the potential to help address many of the barriers that more traditional school-based behavioral mental health implementation strategies have yet to solve, including staffing and resources to implement family-centered support within schools. TRIAL REGISTRATION: ClinicalTrials.gov NCT03060291; https://clinicaltrials.gov/ct2/show/NCT03060291 (Archived by WebCite at http://www.webcitation.org/70f8keeN4). TRIAL REGISTRATION: RR1-10.2196/11106.

Internet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster.

BACKGROUND: There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed. OBJECTIVE: In a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching. METHODS: This was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women's diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9). RESULTS: At the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average. CONCLUSIONS: Our results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf).

Nicotine Metabolite Ratio Is Associated With Lozenge Use But Not Quitting in Smokeless Tobacco Users.

INTRODUCTION: The nicotine metabolite ratio (NMR) of 3'-hydroxycotinine to cotinine is a noninvasive marker of the rate of nicotine metabolism. Fast metabolism (ie, a high NMR) is associated with lower cigarette smoking abstinence rates using transdermal nicotine replacement. We evaluated whether the NMR can be used to predict self-reported nicotine lozenge use and tobacco abstinence among smokeless tobacco users treated for tobacco dependence. METHODS: This was a secondary analysis of data from one arm of a large trial. Participants received quitting support materials and 4-mg nicotine lozenges by mail plus three coaching phone calls. Saliva kits were mailed for collection of saliva samples, which were analyzed for cotinine and 3'-hydroxycotinine. Self-reported tobacco and lozenge use were assessed at 3 months. Analyses were performed using Spearman rank correlation and logistic regression. RESULTS: Of the 160 saliva collection kits mailed, 152 were returned. The NMR was not significantly correlated with the baseline amount of smokeless tobacco used, the number of years of tobacco use, or the level of tobacco dependence as measured by the Severson Smokeless Tobacco Dependency Scale. The NMR was positively correlated with lozenge use (r = 0.21, P = .015), but it did not predict self-reported 7-day point prevalence abstinence at 3 months. CONCLUSIONS: Fast metabolizers may need to self-administer more nicotine replacement in the form of nicotine lozenges to achieve the same clinical response achieved by slower metabolizers using fewer lozenges.

Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation.

BACKGROUND: Use of smokeless tobacco (moist snuff and chewing tobacco) is a significant public health problem but smokeless tobacco users have few resources to help them quit. Web programs and telephone-based programs (Quitlines) have been shown to be effective for smoking cessation. We evaluate the effectiveness of a Web program, a Quitline, and the combination of the two for smokeless users recruited via the Web. OBJECTIVES: To test whether offering both a Web and Quitline intervention for smokeless tobacco users results in significantly better long-term tobacco abstinence outcomes than offering either intervention alone; to test whether the offer of Web or Quitline results in better outcome than a self-help manual only Control condition; and to report the usage and satisfaction of the interventions when offered alone or combined. METHODS: Smokeless tobacco users (N= 1,683) wanting to quit were recruited online and randomly offered one of four treatment conditions in a 2×2 design: Web Only, Quitline Only, Web + Quitline, and Control (printed self-help guide). Point-prevalence all tobacco abstinence was assessed at 3- and 6-months post enrollment. RESULTS: 69% of participants completed both the 3- and 6-month assessments. There was no significant additive or synergistic effect of combining the two interventions for Complete Case or the more rigorous Intent To Treat (ITT) analyses. Significant simple effects were detected, individually the interventions were more efficacious than the control in achieving repeated 7-day point prevalence all tobacco abstinence: Web (ITT, OR = 1.41, 95% CI = 1.03, 1.94, p = .033) and Quitline (ITT: OR = 1.54, 95% CI = 1.13, 2.11, p = .007). Participants were more likely to complete a Quitline call when offered only the Quitline intervention (OR = 0.71, 95% CI = .054, .093, p = .013), the number of website visits and duration did not differ when offered alone or in combination with Quitline. Rates of program helpfulness (p <.05) and satisfaction (p <.05) were higher for those offered both interventions versus offered only quitline. CONCLUSION: Combining Web and Quitline interventions did not result in additive or synergistic effects, as have been found for smoking. Both interventions were more effective than a self-help control condition in helping motivated smokeless tobacco users quit tobacco. Intervention usage and satisfaction were related to the amount intervention content offered. Usage of the Quitline intervention decreased when offered in combination, though rates of helpfulness and recommendations were higher when offered in combination. TRIAL REGISTRATION: Clinicaltrials.gov NCT00820495; http://clinicaltrials.gov/ct2/show/NCT00820495.

From black box to toolbox: Outlining device functionality, engagement activities, and the pervasive information architecture of mHealth interventions.

mHealth interventions that deliver content via mobile phones represent a burgeoning area of health behavior change. The current paper examines two themes that can inform the underlying design of mHealth interventions: (1) mobile device functionality, which represents the technological toolbox available to intervention developers; and (2) the pervasive information architecture of mHealth interventions, which determines how intervention content can be delivered concurrently using mobile phones, personal computers, and other devices. We posit that developers of mHealth interventions will be better able to achieve the promise of this burgeoning arena by leveraging the toolbox and functionality of mobile devices in order to engage participants and encourage meaningful behavior change within the context of a carefully designed pervasive information architecture.

Randomized trial of nicotine lozenges and phone counseling for smokeless tobacco cessation.

INTRODUCTION: Relatively few treatment programs have been developed specifically for smokeless tobacco (ST) users who want to quit. Their results suggest that self-help materials, telephone counseling, and nicotine lozenges are efficacious. This study provides the first direct examination of the separate and combined effects of telephone counseling and lozenges. METHODS: We recruited ST users online (N = 1067) and randomly assigned them to 1 of 3 conditions: (a) a lozenge group (n = 356), who were mailed 4-mg nicotine lozenges; (b) a coach calls group (n = 354), who were offered 3 coaching phone calls; or (c) a lozenge + coach calls group (N = 357), who received both lozenges and coaching calls. Additionally, all participants were mailed self-help materials. Self-reported tobacco abstinence was assessed at 3 and 6 months after randomization. RESULTS: Complete-case and intention-to-treat (ITT) analyses for all tobacco abstinence were performed at 3 months, 6 months, and both 3 and 6 months (repeated point prevalence). ITT analyses revealed a highly similar result: the lozenge + coach calls condition was significantly more successful in encouraging tobacco abstinence than either the lozenge group or the coach calls group, which did not differ. CONCLUSIONS: Combining nicotine lozenges and phone counseling significantly increased tobacco abstinence rates compared with either intervention alone, whereas coach calls and lozenges were equivalent. The study confirms the high tobacco abstinence rates for self-help ST cessation interventions and offers guidance to providing tobacco treatment to ST users.

MomMoodBooster web-based intervention for postpartum depression: feasibility trial results.

BACKGROUND: Postpartum depression (PPD)-the most common complication of childbirth-is a significant and prevalent public health problem that severely disrupts family interactions and can result in serious lasting consequences to the health of women and the healthy development of infants. These consequences increase in severity when left untreated; most women with PPD do not obtain help due to a range of logistical and attitudinal barriers. OBJECTIVE: This pilot study was designed to test the feasibility, acceptability, and potential efficacy of an innovative and interactive guided Web-based intervention for postpartum depression, MomMoodBooster (MMB). METHODS: A sample of 53 women who satisfied eligibility criteria (<9 months postpartum, ≥18 years of age, home Internet access and use of personal email, Edinburgh Postnatal Depression Survey score of 12-20 or Patient Health Questionnaire score from 10-19) were invited to use the MMB program. Assessments occurred at screening/pretest, posttest (3 months following enrollment), and at 6 months follow-up. RESULTS: All six sessions of the program were completed by 87% (46/53) of participants. Participants were engaged with the program: visit days (mean 15.2, SD 8.7), number of visits (mean 20.1, SD 12.2), total duration of visits in hours (mean 5.1, SD 1.3), and number of sessions viewed out of six (mean 5.6, SD 1.3) all support high usage. Posttest data were collected from 89% of participants (47/53) and 6-month follow-up data were collected from 87% of participants (46/53). At pretest, 55% (29/53) of participants met PHQ-9 criteria for minor or major depression. At posttest, 90% (26/29) no longer met criteria. CONCLUSIONS: These findings support the expanded use and additional testing of the MMB program, including its implementation in a range of clinical and public health settings.

Comparative effectiveness of the nicotine lozenge and tobacco-free snuff for smokeless tobacco reduction.

Long-term smokeless tobacco (ST) use is associated with cardiovascular disease and cancer, but not all ST users want to quit. Previous studies have evaluated the effectiveness of nicotine lozenges and tobacco-free snuff for reducing ST use among ST users not ready to quit, but no comparative effectiveness trials of these two products have been conducted. We conducted a multicenter, randomized clinical pilot study evaluating the comparative effectiveness of the 4-mg nicotine lozenge and tobacco-free snuff for reducing ST use and increasing tobacco abstinence among ST users with no intention of quitting in the next 30 days. Participants received 8 weeks of treatment and behavioral counseling on tobacco reduction strategies with follow-up to 26 weeks. We randomized 81 participants (40 nicotine lozenges, 41 tobacco-free snuff). No significant differences in reduction were observed between the two groups at weeks 8, 12, and 26. No significant differences were observed between groups in nicotine withdrawal or tobacco craving. However, both groups significantly reduced (p<.001) ST use in cans/week and dips/day from baseline which was sustained through the end-of-study. The observed biochemically-confirmed abstinence rates at week 26 were similar between groups (12% vs. 12%, one-tailed p=.615). The 4-mg nicotine lozenge and the tobacco-free snuff both appear to be effective and comparable for reducing ST use among ST users not ready to quit in the next 30 days.

Randomized controlled trial of MyLastDip: a Web-based smokeless tobacco cessation program for chewers ages 14-25.

INTRODUCTION: Use of smokeless tobacco (ST) is a significant public health problem for young adults, many of whom want to quit. We describe the outcome of a Randomized Controlled Trial (RCT) examining the efficacy of two web-based ST cessation interventions targeting young chewers. METHODS: One thousand seven hundred and sixteen ST users wanting to quit were recruited online to the MyLastDip program and randomly assigned to one of two fully automated web-based ST cessation interventions: (a) an Enhanced Condition (N = 857) with tailored treatment recommendations and interactive features, or (b) a Basic Condition (N = 859) that provided an online ST cessation guide in static text. RESULTS: Assessment completion rates at 3 months, 6 months, and for both 3 and 6 months were 73%, 71%, and 65%, respectively. No significant differences were found between conditions. Using complete case analysis for repeated point prevalence (3- and 6-month assessments), all tobacco abstinence was 28.9% for participants in the Enhanced Condition and 25.6% in the Basic Condition. Using intent-to-treat analysis, abstinence rates were 35.2% versus 32.3%. Similar results were obtained for ST abstinence. Participants reported being satisfied with their programs and the Enhanced Condition participants were relatively more engaged. Differences in program engagement were not related to tobacco abstinence at 6 months. CONCLUSIONS: Both web-based ST cessation programs encouraged robust levels of absolute tobacco and ST abstinence at follow-up. The absence of between-group differences was discussed in terms of composition of the control condition and implications for next steps in treatment development and testing.

Development and process evaluation of a Web-based responsible beverage service training program.

BACKGROUND: Responsible beverage service (RBS) training designed to improve the appropriate service of alcohol in commercial establishments is typically delivered in workshops. Recently, Web-based RBS training programs have emerged. This report describes the formative development and subsequent design of an innovative Web-delivered RBS program, and evaluation of the impact of the program on servers' knowledge, attitudes, and self-efficacy. METHODS: Formative procedures using focus groups and usability testing were used to develop a Web-based RBS training program. Professional alcohol servers (N = 112) who worked as servers and/or mangers in alcohol service settings were recruited to participate. A pre-post assessment design was used to assess changes associated with using the program. RESULTS: Participants who used the program showed significant improvements in their RBS knowledge, attitudes, and self-efficacy. CONCLUSIONS: Although the current study did not directly observe and determine impact of the intervention on server behaviors, it demonstrated that the development process incorporating input from a multidisciplinary team in conjunction with feedback from end-users resulted in creation of a Web-based RBS program that was well-received by servers and that changed relevant knowledge, attitudes, and self-efficacy. The results also help to establish a needed evidence base in support of the use of online RBS training, which has been afforded little research attention.

A comparison of three smokeless tobacco dependence measures.

Smokeless tobacco (ST) use is associated with tobacco dependence and long-term adverse health consequences. Clinical and research tools that can accurately assess ST dependence are needed to improve research and treatment of ST users. Measures of ST dependence have been developed to address this need. We used data from a study evaluating the effectiveness of bupropion sustained release for the treatment of ST use (N=225) to compare the Fagerström Tolerance Questionnaire for Smokeless Tobacco (FTQ-ST) users, the Severson Smokeless Tobacco Dependency Scale (SSTDS), and the Glover-Nilsson Smokeless Tobacco Behavioral Questionnaire (GN-STBQ). We observed that despite the intention of the scale: (1) all scales were significantly correlated with ST cans consumed per week; (2) the FTQ-ST was significantly correlated with serum nicotine and cotinine concentrations and craving; (3) the GN-STBQ and SSTDS were significantly associated with both craving and withdrawal; and (4) none of the scales were significantly associated with ST abstinence. When all of the scales were entered simultaneously in a multivariable analysis, the SSTDS was the only scale independently associated with withdrawal and craving. As when used with cigarette smokers, the FTQ-ST appeared to measure the construct of physical dependence. The GN-STBQ and SSTDS, designed to measure broader constructs of dependence, were found to predict both withdrawal and craving which may be advantageous in clinical settings. The GN-STBQ and the FTQ-ST did not contribute significantly to the prediction of withdrawal and craving beyond what was accomplished using the SSTDS. The use of the scales is discussed in terms of clinical usefulness and how each scale might assess differing aspects of tobacco dependence.

Web-Based Intervention for Postpartum Depression: Formative Research and Design of the MomMoodBooster Program.

BACKGROUND: Postpartum depression is a significant public health problem affecting approximately 13% of women. There is strong evidence supporting Cognitive Behavioral Therapy (CBT) for successful psychosocial treatment. This treatment model combines cognitive and behavioral strategies to address pessimism, attributions for failure, low self-esteem, low engagement in pleasant activities, social withdrawal, anxiety, and low social support. Encouraging results have been reported for using Web-based CBT interventions for mental health domains, including the treatment of panic disorder, post-traumatic stress disorder, and complicated grief and depression. To date, however, Web-based interventions have not been used and evaluated specifically for the treatment of postpartum depression. OBJECTIVE: We describe the formative work that contributed to the development of our Web-based intervention for helping to ameliorate symptoms of postpartum depression, and the design and key components of the program. METHODS: A total of 17 focus group participants and 22 usability testers, who shared key characteristics with the participants of our planned feasibility study, took part. The proposed structure and ingredients of the program and mock-ups of selected webpages were presented to focus group participants. At various points, participants were asked a series of thought questions designed to elicit opinions and set the occasion for group discussion. At the end of the session, participants were asked to describe their overall reaction to the proposed features of the program emphasizing candid opinions about what they did not like and features they thought were missing and should be added. Usability testers were asked to interact with a series of seven different Web-based interactions planned for the program while receiving minimal direction. Each tester was asked to describe her thoughts using a think-aloud technique. They were then asked to consider all that they had learned about the program and complete the System Usability Scale that we adapted slightly to be appropriate for evaluating the proposed website. Transcripts from the focus groups and usability tests were reviewed by research team members for overarching themes with particular emphasis on suggested changes. A list emerged, and iterative and incremental adjustments were made as a result. RESULTS: The qualitative and quantitative data gathered in the focus groups and usability sessions reported here suggest that the new mothers involved had largely positive reactions to the major features of the program and that those program features performed well in terms of usability. CONCLUSIONS: An overview of the eventual design, architecture, and key program ingredients of the MomMoodBooster program is provided including innovative features supplementing 6 core CBT sessions, which include a partner's website, a library, and individual feedback by a personal coach.

Modeling missing binary outcome data in a successful web-based smokeless tobacco cessation program.

AIM: To examine various methods to impute missing binary outcome from a web-based tobacco cessation intervention. DESIGN: The ChewFree randomized controlled trial used a two-arm design to compare tobacco abstinence at both the 3- and 6-month follow-up for participants randomized to either an enhanced web-based intervention condition or a basic information-only control condition. SETTING: Internet in the United States and Canada. PARTICIPANTS: Secondary analyses focused upon 2523 participants in the ChewFree trial. MEASUREMENTS: Point-prevalence tobacco abstinence measured at 3- and 6-month follow-up. FINDINGS: The results of this study confirmed the findings for the original ChewFree trial and highlighted the use of different missing-data approaches to achieve intent-to-treat analyses when confronted with substantial attrition. The use of different imputation methods yielded results that differed in both the size of the estimated treatment effect and the standard errors. CONCLUSIONS: The choice of imputation model used to analyze missing binary outcome data can affect substantially the size and statistical significance of the treatment effect. Without additional information about the missing cases, they can overestimate the effect of treatment. Multiple imputation methods are recommended, especially those that permit a sensitivity analysis of their impact.

A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users.

Smokeless tobacco (ST) is associated with adverse health consequences yet treatment resources for ST are not widely available. Cost-effective behavioral interventions incorporating self-help materials and counseling calls have been demonstrated to reduce ST use rates and can be easily disseminated, but the feasibility and effectiveness of incorporating pharmacotherapy into this approach have not been evaluated. We conducted a clinical pilot study randomizing 60 patients to 12 weeks of the 4-mg nicotine lozenge or placebo delivered through the mail. All subjects received an assisted self-help intervention (ASH) with telephone support. At the end of the medication phase, lozenges were being used by 63% of subjects in the 4-mg nicotine lozenge group and 43% in placebo. The nicotine lozenge decreased composite withdrawal symptoms and adverse events were minimal. No significant differences were observed in abstinence rates between the two groups at 3 or 6 months. We conclude that the mailing of nicotine lozenges to ST users is a feasible and safe strategy the efficacy of which needs to be evaluated.

A randomized clinical trial of nicotine lozenge for smokeless tobacco use.

INTRODUCTION: Smokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg nicotine lozenge decreases tobacco craving and nicotine withdrawal symptoms among ST users. METHODS: We conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the efficacy of 12 weeks of 4-mg nicotine lozenge for ST use. RESULTS: We randomized 270 participants (136 active lozenge, 134 placebo). No significant differences were observed between the groups in biochemically confirmed all tobacco abstinence rates at Week 12 (36% lozenge vs. 27.6% placebo; odds ratio [OR] 1.5, 95% CI 0.7-2.1; p = .138). However, the 4-mg nicotine lozenge increased self-reported all tobacco abstinence (44.1% vs. 29.1%; OR 1.9, 95% CI 1.2-3.2; p = .011) and self-reported ST abstinence (50.7% vs. 34.3%; OR 2.0, 95% CI 1.2-3.2; p = .013) compared with placebo at the end of treatment (Week 12). Following target quit date (TQD), nicotine withdrawal symptoms decreased significantly with time (time effect = -.022 per day, SE = .003; p < .001) and was significantly lower for the active lozenge (treatment effect = -.213, SE = .071; p = .003). Tobacco craving also decreased significantly following TQD (time effect = -.071, SE = .006; p < .001) and was lower for the active nicotine lozenge (treatment effect = -.452, SE = .164; p = .006). DISCUSSION: The 4-mg nicotine lozenge increased self-reported but not biochemically confirmed tobacco abstinence rates at 3 months. The use of the 4-mg nicotine lozenge is associated with decreased nicotine withdrawal symptoms and tobacco craving.

Methodological issues in research on web-based behavioral interventions.

BACKGROUND: Web-based behavioral intervention research is rapidly growing. PURPOSE: We review methodological issues shared across Web-based intervention research to help inform future research in this area. METHODS: We examine measures and their interpretation using exemplar studies and our research. RESULTS: We report on research designs used to evaluate Web-based interventions and recommend newer, blended designs. We review and critique methodological issues associated with recruitment, engagement, and social validity. CONCLUSIONS: We suggest that there is value to viewing this burgeoning realm of research from the broader context of behavior change research. We conclude that many studies use blended research designs, that innovative mantling designs such as the Multiphase Optimization Strategy and Sequential Multiple Assignment Randomized Trial methods hold considerable promise and should be used more widely, and that Web-based controls should be used instead of usual care or no-treatment controls in public health research. We recommend topics for future research that address participant recruitment, engagement, and social validity.