Lee Ritterband - US grants

DESCRIPTION (provided by applicant): Insomnia is a common problem, affecting over 95 million Americans. In addition to being a source of worry, physical discomfort, and moodiness, the estimated annual cost for the treatment of insomnia is $10.9 billion, costs of reduced productivity due to insomnia is $41 billion, and approximately 56,000 automobile accidents are cited as due to insomnia and fatigue each year. Cognitive-behavioral therapy (CBT) has been found to have significant short-term and long-term benefits as well as excellent patient acceptance. However, while it is often the treatment of choice, availability of CBT for insomnia is limited by many factors, including lack of trained clinicians, poor geographical distribution of knowledgeable professionals, expense, and inaccessibility to treatment and clinicians due to work schedules and competing commitments. This study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. Traditional CBT, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an Intemet intervention system, so individuals can access a personalized treatment any time, at their own convenience. Phase 1 of this study will involve developing the web program. Our research team has extensive experience developing such web interventions, as well as considerable experience with insomnia. Phase 2 will be a pilot test of the Internet intervention. Forty individuals with insomnia will be assessed pre and post the six week treatment program. It is hypothesized that the Internet intervention will promote improvements in sleep, mood, and cognitive functioning, while reducing costs associated with insomnia. Findings indicating feasibility will allow refinement and optimization of the Internet intervention, Phase 3, and creation of a potential future clinical trial.

[unreadable] DESCRIPTION (provided by applicant): An estimated 1.5 percent to 7.5 percent of children suffer from encopresis (fecal soiling). One of the most effective ways of treating encopresis is with Enhanced Toilet Training (ETT). ETT is twice as effective as intensive medical management alone at 3, 6, and 12-month follow-up when delivered by skilled and knowledgeable clinicians. We have successfully transformed ETT into an interactive internet intervention, a web program accessible by anyone with a computer and internet access. This program has been shown to have significant additive value to standard clinical care, and is based on a theoretical model we developed for therapeutic behavior change achieved through internet interventions. To date, this Internet intervention for pediatric encopresis has only been offered to individuals who are currently in treatment with a health care provider. In order to significantly increase its potential for wide-spread dissemination, a new clinical trial is proposed in which families can self-refer to the intervention. In addition, as adherence is often a significant issue with internet interventions, an enhanced condition involving a stepped care approach with graduated levels of support (automated email, personalized email, phone support) for different levels of non-adherence will be evaluated as part of a large, national, randomized clinical trial. We propose a four year project in which we will experimentally test the short and long term benefits of the intervention as compared to use of the system with a stepped care approach to enhance adherence and ultimately symptom improvement. A static, educational website will be used with the control group. Cost-benefit analyses will be evaluated and documented. We hypothesize that the pediatric encopresis internet intervention will be more effective than a static website at 6 weeks and 12 months post treatment in terms of encopretic symptom reduction (including fewer accidents, increased BMs in toilet, and increased trips to the bathroom), behavior change (measured by acceptable cleanout, laxatives, straining, toileting, and routine), and reduced costs (doctor visits, medication usage, missed school/work days, diapers used). We also predict that the stepped care version of the program, as compared to the standard program, will produce greater website utilization and thus improved behavior change and symptom reduction. While overall cost will likely be higher with stepped care, we expect cost-benefit analyses to show that this increased cost is acceptable for a certain segment of the population studied. Additional testing of our model for internet interventions will also be conducted. Relevance: Internet interventions can provide sophisticated and personalized treatment at low cost. This application plans to take a program for children with encopresis and evaluate how effective it is when offered "direct-to-consumers." It also attempts to increase success by integrating methods to improve adherence to the program. Findings from this study will have far reaching implications for the management of encopresis in particular and internet interventions in general. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Abstract Insomnia is a major public health problem, with significant psychological, health, and economic consequences. Studies have demonstrated that face-to-face cognitive-behavioral therapy (CBT) for insomnia is one of the most effective treatments. Despite the therapeutic effectiveness of CBT, treatment availability is significantly limited by a lack of trained clinicians, poor geographical distribution of knowledgeable professionals, and expense. One way to overcome these barriers is to use the Internet to deliver treatment, potentially making this effective intervention more accessible and less costly. In a recent NIH (R34) study, we developed and tested a self-guided, interactive, tailored Internet intervention for adults with insomnia (SHUTi: Sleep Healthy Using The Internet, www.shuti.net). SHUTi incorporates the primary components of CBT for insomnia, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. In the small, local RCT, participants who received SHUTi significantly improved their sleep, whereas the wait-list control group showed no significant changes. Moreover, these improvements were maintained at 6 month follow-up. The proposed study will expand on the R34 trial by including a broader sample, comparing SHUTi to a Patient Education website, and conducting follow-up assessments for one-year to demonstrate potential maintenance of treatment effects. In this new RCT, we will recruit 300 adults with insomnia, including those with comorbid psychological or medical conditions, as part of a 2 (Patient Education vs. SHUTi) X 4 (Pre, Post, 6 and 12 month follow-up) study design. We hypothesize that adults who receive SHUTi will show greater improvements in sleep, mood related symptoms, perceived health status, and overall quality of life compared to those receiving the Patient Education website. We believe that use of SHUTi will result in greater efficacy compared to the Patient Education website at only a moderate increase in costs, resulting in a greater cost effectiveness ratio. We will also test our model for Internet interventions, and begin to identify user characteristics that may be predictive in determining symptom improvement. Because Internet interventions may ultimately be able to reduce health disparity by increasing access to care for geographically isolated patients, we will collect data regarding the sample's access to insomnia treatment. Finally, it is important to note that this proposal is consistent with the recommendations made by the 2005 NIH State-of-the-Science for Insomnia Conference Statement calling for increased research on insomnia treatment. PUBLIC HEALTH RELEVANCE: Relevance: This study will test how well a self-help treatment program for insomnia can be delivered over the Internet. Internet interventions have the potential of overcoming many of the limitations of face-to-face treatments, including availability, accessibility, and cost. Findings from this study will have far reaching implications for the treatment of insomnia in particular and Internet interventions in general.

DESCRIPTION (provided by applicant): Ineffective management of blood glucose (BG) levels during preconception and pregnancy has been associated with severe maternal and fetal complications. Apart from the physical and psychological burden of these complications on patients, healthcare costs related to managing these issues are substantial. Preconception care emphasizing stringent glycemic control in the preconception period and continued through early pregnancy can dramatically reduce these risks. However, the use of preconception care in the US has been disappointingly low due to a variety of organizational, provider, and patient centered factors. Furthermore, efforts to achieve tight glycemic control can increase the risk of severe hypoglycemia (SH) in T1DM women, potentially leading to serious health consequences (e.g., traffic accidents, maternal death). This may also impede patients' progress to achieve their glycemic targets for pregnancy. Aforementioned reasons together make BG management even more challenging for this patient population compared to others with diabetes. There is a vital need to equip this critical population of TIDM women contemplating pregnancy with practical self-management skills that they can actively use to better understand and manage their BG levels, and achieve their target glycemic control without undue risk of hypoglycemia. BGATHome is an automated, tailored, Internet version of Blood Glucose Awareness Training (BGAT), a face- to-face, psycho-educational intervention for T1DM patients developed by our research team. The program has demonstrated effectiveness in terms of improving glycemic control, reducing extreme BG levels, SH, diabetic ketoacidosis, and improving patients' psychological functioning. Historically, in our BGAT-related studies, we have excluded T1DM women who were either contemplating pregnancy or were pregnant during the course of our studies given their unique diabetes-related clinical needs. In this project, we will develop and test a specialized version of BGATHome for use with T1DM women who are contemplating pregnancy to examine its efficacy as an intervention for these women to better regulate their BG levels and to meet their diabetes-related clinical targets for conception. Using formative research with the targeted patients, their significant others, and providers, we will determine and create a new version of BGATHome tailored for this population. This new intervention, BGAT-Pregnancy, will then be tested in a RCT involving T1DM women contemplating pregnancy to examine feasibility and preliminary efficacy. Interviews with trial participants, their significant others, and potential providers will be conducted to enable further optimization of the intervention in preparation for a subsequent R01 submission. This will be the first study investigating the use of the Internet to improve detection and management of extreme BG levels in T1DM women contemplating pregnancy. If proven efficacious, BGATHome for Pregnancy would provide a crucial supplement to preconception care for the US T1DM women, substantially reducing dangerous complications, and improving psychological outcomes. PUBLIC HEALTH RELEVANCE: Pregnancy in women with pre-existing diabetes significantly increases the risk of various complications including spontaneous abortions and major malformations in the newborns. Tight blood glucose (BG) control before and during pregnancy can reduce these risks dramatically. This project will test whether an Internet- delivered training program can improve BG awareness and management in women with Type 1 diabetes contemplating pregnancy. If proven effective, this project has the potential for a significant publc health impact by allowing widespread access for the targeted population and increasing convenience of obtaining care.

? DESCRIPTION (provided by applicant): Insomnia is a significant public health problem for older adults with substantial medical, psychological and financial ramifications. With as many as 20-30% of older adults (age =55) meeting diagnostic criteria for chronic insomnia, finding accessible, effective, and low-cost treatments is critical. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacological intervention that has been shown to be efficacious when tailored for older adults. Regrettably, access to this treatment is significantly limited by a lack of trained clinicians and expense. To overcome barriers to face-to-face care, use of the Internet has emerged as a feasible and effective method to provide health information and treatment. Unfortunately, the health care field has been reluctant to use technology-delivered solutions with older patients out of a concern that older adults either do not have access to or do not want to use technology. However, older adults in the U.S. are the largest growing group of Internet users, and they generally have a desire to learn new technologies. When older adults do use technology-based programs for health promotion, they rate these programs favorably. Internet-delivered CBT-I for older adults has a high likelihood of major public health impact by allowing wide- spread access to a needed intervention, increasing the convenience of obtaining care, and decreasing treatment costs among an age group with high rates of insomnia known to exacerbate other concerns (health, mood, cognition). Our research team previously developed and tested an Internet-delivered, automated intervention based on the primary tenants of CBT-I for adults under 65 (SHUTi: Sleep Healthy Using The Internet, R34MH70805 and R01MH086758). Pilot data with a subset of users aged 55-65 indicates that the Internet intervention is feasible and efficacious in this age group; however, this age group differs from the younger cohort in terms of greater dropout and smaller magnitude of improvement (although still significant). The primary goal of this grant is to conduct the first RCT of an Internet intervention tailored for older adults with insomnia (OAWI). We will recruit 309 OAWI in a 3 (Patient Education (PE) website vs. SHUTi for Older Adults vs. SHUTi-OA + Stepped Care (SC)) X 4 (Pre, Post, 6 and 12 month follow-up) design. We hypothesize that adults who receive SHUTi-OA (or SHUTi-OA+SC) will show greater improvements in sleep and daytime variables compared to those in the PE website. We also expect that SHUT-OA+SC (provision of personalized emails or phone calls to participants not completing assigned tasks) will result in greater utilization and better outcomes than SHUTi-OA without support, but at increased cost. Cost-effectiveness analyses and acceptability curves will determine the incremental benefit achieved with the additional costs. If the Internet intervention proves efficacious in a large RCT, it would yield an effective, relatively low-cost, and readily scalable insomnia solution for the fastest-growing demographic in the U.S. (older adults) who experiences the greatest rates of insomnia.

Project Summary: Sugar-sweetened beverages (SSB, e.g., soda/pop, sweet tea, sports and energy drinks, fruit drinks) are the largest single food source of calories in the United States (US) diet and contributes approximately 7% of total daily energy intake for US adults. Among Appalachian adults, SSB intake is disproportionately high, averaging about 14% of total daily energy intake. There are strong and consistent data documenting relationships among high SSB consumption and numerous health issues such obesity, diabetes, some obesity-related cancers, coronary heart disease, hypertension, and dental decay. Further compounding the SSB problem, the Appalachian region lacks access to providers, medical services, and evidence-based behavioral prevention programs. There is also limited data on technology-based behavioral interventions in Appalachia. However, given recent progress in shrinking the digital divide, the timing is optimal to evaluate technology-based behavioral interventions in this region. The current proposal is designed to target this major SSB dietary risk factor and public health challenge, as well as address notable gaps in the rural e/m-Health literature. Importantly, this proposal builds on our team?s e/m-Health intervention expertise and decade of SSB behavioral intervention research in rural Appalachia. iSIPsmarter is a technology-based behavioral and health literacy intervention targeting SSB reduction and weight reduction/maintenance. It is comprised of six core Internet-delivered modules, an integrated short message service (SMS) strategy to engage users in tracking SSB behaviors, and a cellular enabled scale for in-home weight tracking. iSIPsmarter is a highly interactive, structured, and self-guided program that uses strategies previously proven to promote behavior change. iSIPsmarter also incorporates a stepped care approach to engage users who struggle to complete components of the intervention. The proposed RCT is guided by the RE-AIM framework and targets 244 adults from rural Appalachia. The overall goal is to examine the efficacy of iSIPsmarter in a 2 group [iSIPsmarter vs. static Patient Education (PE) website] by 4 assessment (Pre, 3-, 6- and 18-month follow-up) design. It is hypothesized that iSIPsmarter will be more efficacious at reducing SSB consumption than a PE website at post assessment. Changes in secondary outcomes (e.g. overall dietary quality, weight, quality of life) and maintenance of outcomes at 6- and 18-months post intervention will also be evaluated. Additional secondary aims include to examine reach and representativeness, patterns of user engagement, and cost. Two tertiary aims include exploratory mediation analyses and a systems-level, participatory process to understand context for future organizational-level adoption of iSIPsmarter, and specifically to explore factors that would promote or inhibit a sustainable SSB screening and referral process. The long-term goal of this line of this research is to sustain an effective, scalable, and high reach behavioral intervention to improve SSB behaviors and weight and to reduce SSB-related health inequities and chronic conditions in rural Appalachia and beyond.