Debra L. Barton, Ph.D. - US grants

DESCRIPTION (provided by applicant): Hot flashes are prevalent with menopause and can significantly negatively impact a woman's life. Studies estimate as many as 80 percent of women report hot flashes. Besides being a physiologic phenomenon accompanied by heart palpitations and sweating, hot flashes can also be accompanied by negative emotions such as anxiety and panic. There are limited treatment options with respect to high efficacy and low side effect profile. The current nonhormonal options provide, at most, around 60 percent reduction in hot flashes which is lower than hormones. The goal of this research program is to find both pharmacologic and non-pharmacologic options for improvement in menopausal symptoms, including hot flashes. This pilot study will test the combination of a potentially effective behavioral (non-pharmacologic) intervention, hypnosis, with a known effective pharmacologic intervention, venlafaxine ER. Venlafaxine has been well studied and found to provide a 55 percent reduction in hot flashes. Hypnosis will be tested with both venlafaxine ER as well as a placebo pill. Likewise, we will utilize a control hypnosis comparison as well. The aims of this study are to evaluate the effect size of venlafaxine ER 75 mg with hypnosis compared to venlafaxine ER 75 mg with control hypnosis compared to placebo with hypnosis compared to placebo with control hypnosis, as well as to evaluate the side effects of each of these treatments. We will also evaluate potential moderating variables of expectancy and hypnotizability. The pilot study will randomly assign postmenopausal women reporting hot flashes to one of the four treatment arms described above for 8 weeks, including a baseline week. Hot flashes will be measured daily throughout the trial with a prospective daily diary, including the baseline week. Differences in hot flash reduction between baseline and the last week of treatment will be compared between each arm. Effect sizes and confidence intervals will be calculated. Questionnaires measuring secondary outcomes such as sleep, mood, hot flash interference and menopause related quality of life will be completed before starting the study interventions and at the end of the study. A larger, more definitive trial is planned based on the results and effect sizes of this pilot trial. PUBLIC HEALTH RELEVANCE: This project will be the first step to a larger study evaluating the combination of low dose venlafaxine (37.5 mg and 75 mg) with self-hypnosis for reducing hot flashes. This is a novel combination with the potential to reduce hot flashes equal to estrogen based therapy without significant unwanted side effects. The risk/benefit of estrogen therapy has recently been deemed negative with respect to hot flash management, yet hot flashes can significantly negatively impact one's life. Therefore, effective treatments without unwanted side effects are needed. The novelty of combining a pharmacologic with a non-pharmacologic intervention in a large clinical trial for hot flashes is unprecedented. This pilot study will provide the data to go forward with a large, definitive trial. In addition, information regarding moderating variables of expectancy and hypnotizability will be gained.

Administrative Core - Summary The Center for Complexity and Self-Management of Chronic Disease (CSCD) will address the growing problem of chronic disease. One of the critical cores in accomplishing that objective is the Administrative Core (ACORE). The ACORE will provide the oversight and infrastructure for the CSCD Center. The Executive Committee, the group that will facilitate the operationalization of the Center's scientific vision and resource allocation will be embedded in the ACORE. The ACORE will be responsible for the overall evaluation of the Center and financial stewardship and health. It will be the link to interdisciplinary colleagues and the External Advisory Committee. The aims specific to the ACORE are 1) To leverage complexity to advance the science of self-management for the promotion of health in chronic illness by a) providing consultation and mentorship to interdisciplinary teams around innovative methods for analyzing the effects of complex interventions; b)providing interdisciplinary forums, seminars, workshops and brainstorming sessions; c) establishing a resource bank (with Methods/Analytics Core) with tools (measurement, technology, and /or intervention manuals) that can be used in studies or further developed for other populations; and 2) to develop plans to sustain the CSCD and the interdisciplinary teams who are in its membership by a) facilitating new and continued Center membership through the development of an integrated communication strategy that includes relevant disciplines throughout the University and neighboring health system, b) using real time data quarterly to inform the need for upgrades in processes and c) evaluating outcomes on a biannual basis to facilitate any required changes to improve sustainability. In short, the ACORE will be the working engine for the Center that will enable both the Pilot and Methods/Analytics Cores to be successful in completing their aims.

? DESCRIPTION (provided by applicant): The Center for Complexity and Self-Management of Chronic Disease (CSCD) will address the growing problem of chronic disease. As knowledge and technology addressing disease advances, and the focus on health promotion and illness prevention continues to lag behind, the burden of chronic illness burgeons. Many are concerned about the aging population and the increase in chronic disease, calling for improved efficiencies in the provision of health care. Improved self-management is an important strategy to improve health outcomes in a cost effective manner. Despite much research in self-management, critical gaps in knowledge persist. Current research is limited by designs, methods and analytics that reduce the high number of dynamic, interacting variables into linear equations with select variables that result in missed opportunities for quantum improvements in the desired outcomes. Self-management involves a cluster of behaviors, processes and context, and relationships among the self and provider, health care system, and community. In addition, individuals, families and populations too often are confronted with challenges of multiple chronic illnesses. Research in this complex arena requires methods and analytics that can address non-linear, dynamic relationships between many variables. Though a challenge for the status quo, the Center for Complexity and Self-Management of Chronic Disease (CSCD) is positioning itself to address the following specific aims: 1) to leverage complexity to advance the science of self-management for the promotion of health in chronic illness; 2) expand the number and quality of research investigators who are successful in independently funded careers in self-management research to improve health outcomes; 3) facilitate the dissemination of research findings to the scientific and, when applicable, to the clinical communities and 4) develop plans to sustain the CSCD and the interdisciplinary teams who are in its membership. To accomplish these aims, we will establish three cores, administrative, pilot and methods/analytics. The Center will be guided by Individual and Family Self-Management Theory that has been informed by Chaos Theory. In short the overall purpose of the Center for Complexity and Self-management of Chronic Disease is to address the need for innovative research that encompasses complexity in order to advance the science in self-management to achieve clinically important outcomes such as minimizing disability, optimizing function and living well. In addition, the Center will facilitate interdisciplinary approaches and expand the pool of interdisciplinary research teams who are equipped to successfully develop and implement externally funded programs of research in self-management. We plan to change the landscape of self-management research and thereby advance the science in efficient, meaningful ways.

DESCRIPTION (provided by applicant): Enhancement of Thai nurses' research capacity will successfully harness their roles as knowledge providers who can address critical health priorities in Thailand. Those priorities in Thailand are non-communicable diseases (NCDs) as they are projected to soon become the leading causes of morbidity and mortality in that country. There is a need for nursing and health systems research aimed at improving prevention, primary care, and long-term chronic disease management. The proposed program builds on a long standing collaboration between the UMSN and an institute within the MOPH, the Praboromarajchanok Institute for Health Workforce Development (PBRI). Instructors, mentors and advisors from both organizations will contribute to a varied and integrated training plan. The Specific Aims of this 5 year proposed training program are: 1. Provide a two year post-doctoral research training program in NCDs for 10 PhDs in nursing or related discipline; 2. Expand short term training (one to three months) for 40 PhD prepared investigators to strengthen their understanding of methodology, analysis and policy applications for NCDs research; 3. Provide forums for mid- and high- level research administrators within the MOPH and in universities and institutes of Thailand, to discuss methods and means to enhance and expand research capacity for NCDs in Thailand; 4. Provide a foundation of NCD research capacity in Thailand for potential expansion to the SEAR region. Specific components of the program include: 1) A long-term postdoctoral research training program for 2 trainees per year including one year mentored research at the UM campus and one year mentored research project implementation in Thailand; 2) Short-term training of 1- 3 months for 8 trainees each year offering specific training options tailored to the trainees; and, 3) A yearly three- day research workshops in different geographical regions of Thailand. The MOPH health delivery system, which encompasses nearly 90 percent of the Thai population, will be strengthened through nurse-led research with a focus on prevention, health promotion across the lifespan, and interventions at the individual, community, population and policy levels for NCDs. Specific emphasis will be on the most significant NCDs in Thailand at this time; cardiopulmonary and cardiovascular ischemic diseases and cancer with supporting areas such as pain management, clinical protocols for NCDs, and models of care delivery (e.g. implementation and effectiveness methodologies).

Abstract Hot flashes negatively impact 80% or more of the female population experiencing menopause due to aging and/or diagnosis and treatment for breast cancer, causing decreases in both emotional and physical role functioning. The most effective treatment for hot flashes, estrogen based treatment, is either contraindicated or a cause for worry amongst many women due to cancer and serious side effect risks. Some non-estrogen based treatments have been found effective, but they also can have a negative risk-benefit ratio. Effective, non-hormonal treatments for hot flashes that are not associated with unwanted side effects and are accessible to all women are needed. Hypnotic relaxation therapy is a mind-body intervention that has demonstrated the ability to reduce hot flashes in women experiencing menopause from natural aging as well as breast cancer treatment and has recently been added to a clinical guideline for hot flash management by the North American Menopause Society. However, access to this effective treatment is limited by a lack of trained and/or certified licensed providers. According to an IOM report on women?s health, efforts are needed to be able to translate effective guideline based treatments broadly into practice. This study represents the next step to meet that critical objective. This application proposes a multi-site, two arm, randomized controlled trial with 224 postmenopausal women to accomplish the following specific aims: 1) Evaluate efficacy of a fully self- administered hypnosis compared to an equivalently structured attention control group; 2) Evaluate efficacy of the self-administered hypnosis compared to structured attention for sleep, mood, and hot flash related quality of life, and 3) Explore potential mechanisms by assessing mediators and moderators of effectiveness. This research has the potential to be the gateway to the broad dissemination of a powerful intervention against hot flashes and to illuminate mechanisms of action upon which to build further interventions. This study is innovative because it seeks to deliver a provider intensive therapy in a fully self-administered way, and to explore mechanisms by which it reduces hot flashes.