Kelly M. Carpenter, Ph.D. - US grants

DESCRIPTION: We know that brief interventions lasting 3 minutes or less can help smokers quit more effectively. Despite this, most clinicians (physicians, pharmacists, dentists, nurses, etc.) do not conduct smoking cessation interventions in the course of their practice. Lack of clinician knowledge and skills about smoking cessation, and smokers' resistance to quitting are major barriers to better practice. Motivational Interviewing (MI) tailors interventions to address patient readiness to change and overcome resistance. In this way, the right intervention is delivered at the right time. MIRIS, an internet-based training program, teaches clinicians MI for smoking cessation. This is accomplished through simulated interviews in which clinicians interact with computer-modeled patients. In MIRIS simulations, learners are questioned about their actions and understanding of the assessment and intervention process and then given targeted feedback. After acquiring basic knowledge, learners respond to simulated patients by speaking aloud in real time. These oral practice sessions may help clinicians break the "speaking barrier" that can inhibit use of unpracticed skills. We hypothesize that learners trained with MIRIS will evidence improved MI skills, reducing the knowledge barrier for clinicians and preparing them for encounters with patients who are resistant to change.

DESCRIPTION (provided by applicant): Exposure to trauma is common in the U.S. A significant proportion of these exposures lead to serious impairment in functioning, including post-traumatic stress disorder (PTSD). Although there are empirically supported treatments (EST's) for PTSD, many do not get the treatment they need. This grant proposes to use the Internet to deliver a coping skills workbook for PTSD patients as a supplement to face-to-face treatment. Technology enables this workbook to be highly interactive with a multimedia presentation format (e.g. audio, animation, and video) and feedback customized for each user. Mental health professionals will assign modules based on their clients' individual needs. The workbook will teach coping skills gathered from EST's and will include training in symptom identification, relaxation skills, mindfulness, affect regulation, and cognitive restructuring. Each module will include psycho education, on-line exercises, self-monitoring assignments, and individualized feedback. An accompanying "clinician guide" will consist of individualized reports of the patient's progress with suggestions about how to facilitate the strengthening and generalization of the skills. We will also conduct a clinical utility and usability study. PROPOSED COMMERCIAL APPLICATION: PTSD is a common and costly psychiatric disorder. In an era of managed care, clinicians are pressed to find more efficient ways of effectively treating their patients. Internet-based treatments are potentially effective and cost saving ways to supplement face to face psychotherapy. Community mental health centers, clinics, and private practice psychotherapists are all potential customers for "Internet-based coping skills training for PTSD."

DESCRIPTION (provided by applicant): Most adult patients are treated for depression in primary care settings. Unfortunately, few receive treatment that meets the recommended guidelines. The current project, Technology Enhanced Depression Intervention for primary care (TEDI), proposes the use of technology as a substitute for time-intensive provider contact so that this scarce treatment resource can be applied more effectively. We propose to develop a system to monitor patient medication compliance via wireless two-way communication devices (pagers). Pagers enable us to send medication reminders and educational messages, and monitor compliance and side effects. In the event of noncompliance or serious side effects, the system is able to automatically contact providers. In addition, supplementary behavioral treatment will be delivered via the World Wide Web. This interactive multimedia tutorial will teach behavioral skills derived from cognitive-behavioral therapy using assessment and feedback, psychoeducation, structured exercises, homework, and homework monitoring. TEDI is not meant to take the place of human intervention and treatment. Rather, it is a supplemental tool, designed to augment providers' treatment and notify them when further human intervention or judgment is required. Recognizing both the benefits and limitations of technology, we envision this technology being integrated into a step-care approach to the treatment of depression. PROPOSED COMMERCIAL APPLICATIONS: A low-cost tool that enhances the treatment of depression in the primary care setting would have many potential customers. Phase 3 commercialization will likely involve partnership with a company already active in our target markets such as disease management companies, large insurance carriers, or pharmaceutical companies that make anti-depressant medication.

DESCRIPTION (provided by applicant): Alcoholism is a costly and difficult societal problem and treatment programs are often unsuccessful. One consistent finding in the literature is that better outcomes occur with improved treatment retention. ASEAD (Adaptive Support Environment for Alcohol Dependence) is a tool designed to improve treatment retention. It uses pagers to send patients messages that remind them to go to treatment appointments, to apply what they are learning in treatment to their daily life, and to engage in behaviors consistent with a clean and sober lifestyle. Our Phase I study demonstrated that our intervention was both technically feasible and positively received by patients, who found the pager both easy to use and helpful in their treatment. The goal of the Phase II project will be to make ASEAD a product that will be used. Therefore, we will (1) involve drug and alcohol treatment agencies (administrators and providers) in the design of the pager system, (2) design and implement software flexible and robust enough to accommodate their needs, and (3) test this intervention with a randomized trial designed to measure (a) usability and utility from the perspective of treatment providers and agencies (our ultimate customers) and (b) patient outcome variables related to treatment.

[unreadable] DESCRIPTION (provided by applicant): Recent evidence indicates that the rate of new HIV and STD infections among men who have sex with men (MSM) is rising, especially among MSM under age 30. Communities of color appear to be at particular risk. Phase I of this project developed an HIV preventative intervention program with informational, motivational and behavioral components via an interactive, multimedia computer tutorial. Usability of the Safer Sex Tutorial was successfully demonstrated with 32 young MSM, including 40% minority MSM. The proposed Phase II Safer Sex will continue with increased flexibility, will be available initially in physician's offices and other MSM oriented agencies. The expanded program will include multiple levels of branching; and it will provide targeted motivational interventions for MSM currently at high risk and low to moderate risk, based on their intention to change their more risky activities. The program will be designed to be delivered by CD-Rom or through the internet at MSM-oriented websites and chat rooms. The major study for Phase II involves a total of 140 MSM who will be randomly assigned to experimental condition (the Safer Sex II Tutorial or traditional risk reduction information chosen by our experts from MSM agencies, which will be designed to take the same amount of time as the Tutorial (45 minutes to an hour). There will be an immediate post-test for both groups, measuring information and attitudes. There will also be a 3 month and a 6 month computerized assessment follow up for both groups, assessing risky behaviors, knowledge about risk reduction, and attitudes toward changing risky behaviors. HIV and AIDS treatment is very costly. An empirically based HIV prevention method with the ability to reach a wide audience at low cost is quite attractive to organizations that have either a financial incentive or a public health responsibility to address the issue of HIV/STD. [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): Exposure to trauma is common in the US. A significant proportion of these exposures leads to serious impairment in functioning, including posttraumatic stress disorder (PTSD). Although there are empirically-supported treatments (EST's) for PTSD, many individuals do not get the treatment they need. This grant proposes to use the Internet to deliver a coping skills workbook for PTSD patients as a supplement to face-to-face treatment (Strategic Personal Resources for Overcoming and Understanding Trauma: SPROUT). Technology enables this workbook to be highly interactive with a multimedia presentation format (e.g., audio, animation, and interactive exercises) and customized feedback. SPROUT will teach coping skills gathered from EST's and will include training in symptom identification, relaxation skills, mindfulness, affect identification and regulation, and cognitive restructuring. Each module will include psychoeducation, on-line exercises, self-monitoring assignments, and individualized feedback. An accompanying clinician website will consist of individualized reports of each patient's progress with suggestions about how to facilitate the strengthening and generalization of the skills. In Phase I, two pilot modules were completed (Introduction to PTSD and Basic Relaxation Skills) as well as the content for a third module (Advanced Relaxation). A successful feasibility study was conducted wherein the two pilot modules were used and evaluated by 30 PTSD patients. These participants gave the modules very high ratings. Phase E will complete the ten workbook modules as well as patient and companion clinician websites (including discussion board options for patients). A randomized clinical trial of 128 PTSD patients will be conducted on the completed product using six private practice clinicians as research therapists. SPROUT is expected to reduce PTSD symptoms, increase symptom management self-efficacy, and increase patient satisfaction. [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): Cognitive behavioral (CBT) approaches to chronic pain management are effective for reducing patients' experience of pain and improving functioning and quality of life. Non-pharmacological treatments for pain are strongly endorsed as an important component of a comprehensive pain management approach by organizations such as the American Pain Society, the America Geriatric Society, and the Joint Commission for the Accreditation of Health Care Organizations (JCAHO). The goal of the present project is to develop an Internet-delivered Chronic Pain Workbook which offers a low-cost CBT pain management intervention to chronic pain patients. This Pain Workbook can be used as a stand-alone intervention for patients unwilling or financially unable to seek help from psychologists or other CBT providers or as an adjunct to a comprehensive pain management program. The proposed Pain Workbook will be more than pages of text displayed sequentially on a computer screen. Computer technology enables this workbook to be highly interactive, to use a multimedia presentation format (e.g., sound, animation, and graphics), and to tailor information for the individual user. In Phase I, we propose to develop 3 chapters of the Pain Workbook: a pain education chapter which presents the mind/body treatment rationale, a cognitive restructuring chapter, and a chapter which teaches patients to set small reasonable goals consistent with their larger life goals and to engage in active problem-solving. Our team of expert consultants will assist us in developing the content of the Phase I chapters. We will also conduct a small randomized study using a wait-list control group design. This study will evaluate the impact of the prototype chapters on pain patients' beliefs and attitudes about pain. We will also collect information regarding usability and functionality of the Pain Workbook. The Phase II plan is to complete the Pain Workbook and to conduct a larger randomized effectiveness trial. [unreadable] [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): Cognitive Behavioral Stress Management (CBSM) interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer. CBSM interventions use well-validated cognitive behavioral techniques such as relaxation and meditation training, cognitive restructuring, and communication skills training to increase active, adaptive coping and are typically delivered in a group setting. The present project aims to develop an online version of a CBSM intervention for women undergoing adjuvant treatment for early stage breast cancer. Phase I achievements included developing the user interface and two prototype modules of the web-based intervention. These two modules ("Introduction to Relaxation" and "Communication with Healthcare Providers") were created with Talaria's proprietary software, are highly interactive, and are presented in a multimedia format. Two usability studies, one in- person and one online, with 62 current and past cancer patients, demonstrated high levels of approval, satisfaction, and ease-of-use. In Phase II goals are to develop the entire intervention and examine its effectiveness in a randomized clinical trial. This 10-module intervention will consist of cognitive behavioral techniques adapted for web-presentation by Talaria's experienced eLearning team of clinicians, researchers, writers, programmers and multimedia experts. Each module will include self- assessment and targeted feedback, didactic psychoeducation, interactive exercises, and opportunities for self-monitoring-- all tailored to the needs of women with early stage breast cancer. In addition, guided written self-disclosure exercises will promote emotional expression and a discussion board will encourage group support. The web-based intervention will be usability tested and the final product will be evaluated in a randomized clinical trial with a sample of 120 women in adjuvant treatment for breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone. Outcome measures include patients' confidence in their coping abilities, benefit finding, quality of life, and cancer-related distress. We plan to market this product directly to cancer patients, as well as to cancer care providers, hospitals, clinics and pharmaceutical companies that manufacture cancer medications. Public Health Relevance: Nearly 200,000 American women are diagnosed with breast cancer every year. As they go through cancer treatment, many patients experience a significant decline in their quality of life due to stress, treatment side effects, anxiety, depression, and relationship difficulties. We propose to develop a web-based version of Cognitive Behavioral Stress Management, an empirically supported intervention for women with breast cancer. This web intervention will be convenient, private and available for low cost to women regardless of location or insurance coverage. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Between 10 and 28 percent of Americans suffer from chronic low back pain (CLBP). Chronic pain self-management programs that include behavioral and cognitive-behavioral therapies (CBT) have been demonstrated as effective in improving pain, function, and quality of life. These techniques are endorsed as an important component of a comprehensive pain management approach by several national organizations, including the American Pain Society and the Joint Commission for the Accreditation of Health Care Organizations. Since access to CBT for chronic pain is limited, there is a tremendous need for safe, effective, low-cost self- management programs for individuals suffering from CLBP. Toward this end, this project developed an interactive online intervention, the Wellness Workbook (WW). In Phase I research, a pilot version of the WW was developed and customized for individuals with CLBP. The WW is an interactive web-based intervention consisting of a mind/body treatment rationale, pain education, and instruction in cognitive-behavioral pain management techniques. The efficacy of the Phase I WW was evaluated in a randomized, waitlist-controlled trial with 118 individuals with CLBP. Results indicated that those who used the Phase I version of the WW for 3 weeks endorsed more adaptive beliefs regarding pain control and showed improvements in self-efficacy, mood regulation, helplessness, and fearful avoidance of physical activity. Phase II will consist of further development and piloting of the WW and supplemental tools such as a moderated discussion board and a physical activity planning tool. Efficacy of the final WW intervention will be evaluated in an RCT with 198 CLBP patients recruited over the internet. Intervention group participants will use the WW intervention for 10 weeks and control group participants will be given print materials. Both groups will be receive bi-weekly telephone check- ins. Outcome variables will include pain-related disability, pain interference, disabling attitudes and beliefs, mood and physical activity levels. Assessments will be given at base-line, post- intervention (10 weeks) and at 8 weeks follow-up. The WW will be marketed through primary care and specialty clinics and will be available at low cost to individual patients. PUBLIC HEALTH RELEVANCE: Chronic lower back pain is one of the most widely experienced health problems in the United States, is a leading cause of disability and has an estimated cost of $30 to $70 billion yearly. Cognitive and behavioral approaches (CBT) are established, empirically supported treatments that improve quality of life, functioning and reduce pain-related disability for chronic pain patients. The present project will develop a web-based CBT intervention for chronic low back pain which will be effective, convenient, private and available for low cost to patients regardless of location or insurance coverage.

DESCRIPTION (provided by applicant): Treatment and prevention of many chronic health problems, such as HIV infection, are significantly influenced by stress and behavior. Yet, many healthcare providers and students lack knowledge about how stress and behavior interact with physiological processes such as immune and endocrine functions. The purpose of the present project is to produce an evidence-based online encyclopedia of behavioral medicine (EBM) that can serve as an e-textbook or a reference for students and healthcare professionals. This encyclopedia will consist of four volumes. Volume one will present a foundation in behavioral medicine constructs-including reviews of immunology, neurology, and endocrinology and a primer on research principles and the scientific method-for students and professionals from a range of backgrounds. Volume two will explore mechanisms underpinning possible relationships between psychosocial variables and health. Volume three will focus on disease-specific research (e.g., psychosocial influences on HIV). Volume four will investigate research evidence for behavioral medicine interventions. Use of the EBM will allow clinicians, researchers or students with diverse experiences to acquire sufficient information to understand and apply biopsychosocial theory and techniques. In keeping with modern medical informatics, this encyclopedia will be an interactive multimedia web- based electronic book (eBook) and educational support website. All references in the encyclopedia will be actively linked to PubMed and other Internet resources. Other features will include indexing and search functions, note taking, highlighting, automatic updates through NCBI, and interactive figures, illustrations and exercises. Institutions and professors will be able to customize their version of the eBook (e.g., by annotating the text and adding hyperlinks). The EBM will not be a static entity, but will be dynamic, changing and expanding as new research is published. Social functions, such as discussion boards will be available and users will be able to make suggestions and offer feedback on the content of the encyclopedia and, after thorough and careful examination by experts, suggestions will be incorporated into the text. In Phase I we propose to show proof of concept by completing the textual content for eight chapters of the eBook. We will develop sample interactive exercises, assessments, figures and other features of the eBook and website using HIV as an example disease. We will usability test the eBook and website user interfaces (UIs), interactivity and content with three potential user groups (medical students, psychology graduate students and university professors teaching relevant courses). In Phase II we will complete development of the online encyclopedia and conduct a study of the educational effectiveness of the EBM, including the discussion boards and other social features. PUBLIC HEALTH RELEVANCE: Treatment and prevention of many chronic health problems, such as HIV infection, are significantly influenced by stress and behavior. Yet many healthcare providers and students lack knowledge about how stress and behavior interact with physiological processes such as immune and endocrine functions. The proposed online encyclopedia of behavioral medicine will educate healthcare providers and students in the ways in which psychosocial and behavioral variables impact disease and health outcome and will also review the literature regarding the effectiveness of behavioral interventions on physical health.

Intensive behavioral weight loss programs are effective in helping people achieve the clinical recommendation of 5-10% weight loss, although efforts to disseminate less expensive and time consuming programs have found reduced effectiveness. Stress appears to be a critical factor impacting weight loss and maintenance, but although stress may be mentioned in weight loss programs, specific stress management skills and strategies for weight loss are not typically emphasized. The present project proposes to integrate mindfulness-based stress management into an existing employer-sponsored telephone counseling and internet-based weight loss program with the goal of improving outcomes. Project hypotheses are that the integration of mindfulness-based stress management with a behavioral weight loss program will increase the effectiveness of the program for those participants reporting high levels of stress-related eating. Content of the intervention includes a mind/body treatment rationale and direct and experiential mindfulness and mindful eating instruction with the goal of decreasing perceived stress and the associated overeating that accompanies it. During the two year project funding period, the investigators will develop the intervention and evaluate the feasibility and efficacy of the intervention by conducting a preliminary randomized trial. This trial will compare the integrated stress and weight loss treatment to weight loss treatment as usual in 183 overweight and obese individuals. Primary outcomes will include internal disinhibition (eating in response to emotion or thoughts), eating self-efficacy, perceived stress and weight lost at 6 months.