40 Clinical Trials for Various Conditions
Exposure to sexual violence disproportionally impacts women Veterans and can have profound negative impacts on daily functioning. Current treatments for sexual violence focus on psychiatric symptoms and ignore frequently co-occurring physical and psychosocial concerns. Exercise can improve trauma-related physical, mental, and psychosocial health conditions and may help women who have experienced sexual violence. Yet, women Veterans experience many barriers to participating in exercise and prefer interventions that are tailored to their preferences. This proposal will develop and test an exercise intervention tailored specifically to women Veterans who have experienced sexual violence. Treatment development will be informed by women Veterans with histories of sexual violence and their providers. Feasibility and acceptability will be tested, and outcomes will be explored to inform future research. This intervention is urgently needed to address gaps in integrative care and persistent trauma-related health concerns among women Veterans with histories of sexual violence.
Women are the fastest-growing group of U.S. Veterans. Over half of those using VA care are 45 or older, with more age-related health concerns than civilian women. The VA urgently needs gender-informed strategies to ensure women Veterans receive tailored care that addresses their intersecting mental, physical, and age related health concerns, as well as gender-linked stressors. One prominent example is menopause, a health transition period that, for many women, can be associated with negative physical and mental health concerns that can worsen their functioning and quality of life. This project will: (1) integrate stakeholder feedback to tailor Cognitive Behavioral Therapy for Menopause (CBT-Meno) for women Veterans with menopause concerns; and (2) refine and evaluate tailored CBT-Meno as a treatment to address these intersecting needs in a clinical trial.
The goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans, and 3) identify appropriate pain-related treatment outcomes for the larger randomized trial. Participants will be randomly assigned to participate in either the ACT condition or treatment as usual condition, complete three surveys (before, after, and 3-months after first survey), and complete a phone interview (if assigned to the ACT condition). Researchers will compare the ACT condition and treatment as usual condition to see if there are meaningful differences in health outcomes. Due to the small sample size and pilot nature of this study, significance testing will not be performed.
This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment and the psychoeducational intervention is modeled after usual care in a VA Women's Mental Health Clinic. The study objectives are to: 1) Iteratively refine the structure and materials of trauma-informed CBT-I in preparation for a pilot trial, 2) Pilot test the effects of trauma-informed CBT-I on PTSD treatment readiness and engagement in a sample of women Veterans, and 3) Examine potential mechanisms underlying variations in PTSD treatment readiness and engagement over time among women Veterans. Women Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Then Veterans who meet all eligibility criteria will be randomly assigned to trauma-informed CBT-I (n=25) or the psychoeducational intervention (n=25). Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=50) will have 2 follow-up assessments (post-treatment and 3-months). The follow-up assessments will collect information on PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Chart reviews will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (treatment engagement measure). Qualitative interviews will be conducted to identify mechanisms underlying PTSD treatment engagement.
This research project will refine and evaluate delivery of a peer-delivered evidence-based intervention to improve perceived access and actual engagement with mental health treatment and social resource service use among rural women Veterans, especially Veterans of color, with psychological distress and unmet social needs.
The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mHealth UI modality alone and (2) the practice facilitation toolkit with a mHealth UI model combined with education on clinical pathways for consultation. Patient level outcomes related to UI symptom improvement will be compared. Patient and provider perceptions of factors that could influence future remote UI treatment scalability will also be assessed. All primary care practices will receive practice facilitation with a PURSUIT toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mHealth application training (MAT); 3) online resource hub; and (4) health information technology (HIT) assistance. PURSUIT's future goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for women Veterans nationally within the VHA.
Chronic pelvic pain (CPP) is a debilitating condition that disproportionately affects women Veterans (25% vs. 16% of civilian women). Predisposing factors include higher rates of strenuous physical activity during military service, duty-related injuries, psychiatric distress, and sexual trauma. CPP is associated with a high burden of illness, disability, and economic costs (estimated at $5.8 billion in annual health care expenditures). Multimodal, interdisciplinary approaches are emphasized in the treatment of CPP. Psychological interventions are essential for optimizing pain self-management for CPP. Psychosocial factors are known to affect pain intensity and recovery. Women Veterans report higher rates of depression and anxiety with CPP, that leads to greater disability and poorer quality of life. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are effective options for pain self-management. Barriers to effective pain treatment are high attrition and non-adherence. Additionally, women Veterans prefer treatments that address their gender-specific needs. Gender-specific services remain limited in the Veterans Health Administration (VHA). In line with VHA's priorities to expand women's health care, this study implements ACT in a brief intervention format to address a highly prevalent reproductive health issue among women Veterans. ACT is transdiagnostic and thus provides a unified approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Brief workshop formats increase treatment completion and patient engagement. This study seeks to adapt an existing 1-day ACT workshop for use in VHA integrated primary care (PCMHI) and specialty medical settings with women veterans experiencing CPP. Primary outcomes are feasibility and acceptability of the adapted intervention.
This project tests Brasthesis, a new product for women Veterans with upper limb loss. Brasthesis incorporates the harnessing straps that hold the prosthesis to the body into a heavy-duty sports bra. The position of the harnessing straps are individualized for each woman so that the prosthesis can be positioned for optimal contact between the prosthetic sensor and the residual limb. The investigators foresee Brasthesis being available as an adaptable sports bra that comes with a goodie bag of spare parts that can be used to customize Brasthesis. The investigators plan to develop Brasthesis to be machine washable and relatively inexpensive so that Veterans can have more than one in a variety of colors.
The purpose of this study is to determine the effect of a novel menopause hormone therapy on blood sugar (glucose) and blood and liver fats (lipids) in obese menopausal women Veterans.
Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.
The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. The study will test the effect of sending a weblink to the decision tool to women Veterans prior to primary care visits at the VA. Half of participants will be sent a weblink before their appointment, and half will not be sent the link. The investigators hypothesize that participants who are sent the link will be more likely to report patient-centered discussions of their reproductive needs at visits, feel confident in communicating with their health care providers, have accurate knowledge about reproductive health, and choose birth control methods that best fit their preferences and needs.
The purpose of the study "Stress, Emotion Regulation, and Alcohol in Women Veterans" is to learn about the effects of negative emotion and stress on behavior (including alcohol use) among women Veterans, including women with and without posttraumatic stress disorder. Additionally, the study looks at whether a woman's use of emotion regulation techniques changes the association between stress or negative emotion and behavior. Lastly, the study examines how women's reactions to stress, and the effects of stress, vary across the menstrual cycle - depending on the level of circulating hormones.
This study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. By doing this study, the investigators hope to learn which treatment method is the most helpful remote delivery method for treating bladder leakage. The total participation time in this research is 6 months. During the first 8 -12 weeks of the study, you will receive standard of care from an online educational program (MyHealtheBladder) or a video visit with a provider through VA Video Connect. You will be selected by chance to receive MyHealtheBladder or VA Video Connect. About half-way through the study, the investigators will ask you about your bladder symptoms. If your bladder symptoms are not better, you will be selected by chance to continue the previous treatment or receive an initial or booster video session with a provider. Throughout the study, you will be asked to answer questions related to your health, bladder leakage, costs due to bladder leakage, and track your behavioral training.
Up to 20% of women Veterans (WV) using VHA primary care experience past-year intimate partner violence (IPV), which contributes to numerous physical and mental health conditions, including suicidality. Despite national recommendations to screen WVs for IPV, there is low adoption of IPV screening programs in primary care. In response, VHA is spreading IPV screening programs in Women's Health Model 1 and Model 2 primary care clinics, where the majority of WV VHA primary care patients receive care. The systematic and effective implementation of IPV screening programs within primary care clinics is expected to enhance care for WVs as well as improve access to, and timeliness of, IPV-related care. Given the high prevalence of IPV among WVs and its significant negative health effects, successful implementation of IPV screening programs is expected to reduce morbidity among WV VHA patients. This stepped wedge hybrid II implementation/effectiveness study will assess efforts to implement routine IPV screening for WV VHA patients.
The proportion of US Veterans who are women is currently at its highest point in history and is projected to continue increasing. Nonetheless, the literature regarding prosthetic and functional outcomes in women Veterans with lower extremity amputation (LEA) is nearly non-existent. Research in other healthcare systems indicates the presence of concerning gender differences in both prosthetic outcomes and functional mobility, with women being less likely to be prescribed a prosthesis, less likely to use it, and more likely to be dissatisfied than men. This mixed-methods study will use VA administrative data, qualitative interviews, and a patient survey to characterize women Veterans' outcomes as well as compare them to those of male Veterans, resulting in the largest study to date on women Veterans with LEA. Data from this rigorous evaluation will inform clinical care by identifying intervention targets to improve prosthetic and functional outcomes for this understudied population.
This study is a randomized controlled trial (RCT) to test two sleep apnea education programs for women Veterans newly diagnosed with sleep apnea (SA) who are prescribed positive airway pressure (PAP) therapy. This education program is designed to improve participants' sleep quality and help them to adjust to PAP therapy. Participants undergo a sleep and health assessment that is performed prior to beginning the education program. This assessment includes wearing a wrist actigraph to measure sleep and wake periods for 7 days and nights, and answering questionnaires about sleep habits and health. Participants are randomly assigned to one of two 6-week programs (intervention or educational control) provided by a study interventionist. Follow-up sleep and health assessments will be conducted at the end of the 6-week program and 3-months later. PAP usage data will be collected remotely for 6-months from PAP therapy initiation.
The purpose of this research study is to examine the impact of educational secure messages on menopause. In particular, the investigators will examine whether the secure messages increase menopause knowledge and communication between patients and their providers.
Implementation of Tailored Collaborative Care for Women Veterans (CCWV) was designed to enhance primary care-mental health integration for women Veterans by tailoring services to women Veterans' and providers' needs and providing an evidence-based intervention, Coordinated Anxiety Learning and Management, to address anxiety and depression in a patient-centered approach. CCWV was implemented in two of the Women's Health Practice-Based Research Network sites, with careful attention to local tailoring and adaptation to enhance the fit of the care model in varied local contexts.
The purpose of this study is to evaluate an online PTSD intervention that was adapted for women Veterans, called DElivery of Self TRaining and Education for Stressful Situations-Women Veterans version (DESTRESS-WV). The intervention consists of structured online sessions as well as weekly brief phone calls for additional support with a study coach. Women Veterans with PTSD who are eligible will be randomized to receive either DESTRESS-WV or phone monitoring only for 8 weeks. Participants will be assessed immediately post-treatment as well as at 12 and 24 weeks post-treatment. Investigators hypothesize that participants randomly assigned to DESTRESS-WV will have a greater decrease in severity of PTSD symptoms compared to those randomly assigned to phone monitoring only.
In this study, we are evaluating the effectiveness of a yoga intervention to treat posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia, and biological and physiological responses to trauma and PTSD in women Veterans who experienced military sexual trauma (MST). If effective, this yoga intervention could reduce PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic "fight or flight" stress response and the damage this stress response causes in the body, including heart disease and diabetes. This intervention could improve these women Veterans' quality of life and social functioning, for example, going to work and having satisfying relationships with family and friends. This study may support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. This new, evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines for this yoga intervention could be implemented nationally in the VA health care system.
The immediate objective of this project is to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention to female rural veterans, Reservists, National Guardsmen, and civilians suffering with PTSD. This study is an expansion, seeking to add a treatment arm of women, to an already CDMRP-funded study that completed in July 2014 treating male combat veterans with military-related PTSD. The long-term objective of this project is to disseminate an empirically sound TMH PTSD protocol for male and female veterans, Reserve and Guard that will extend the use of CPT to remote rural sites. It is hypothesized that using VTC, will be as effective as the in-person mode of service delivery for providing CPT.
Women Veterans have high rates of insomnia. Prior research and our preliminary findings show that insomnia impacts the health and quality of life of women Veterans and that those with insomnia prefer non-medication treatments over sleeping pills. This study compared two non-medication behavioral treatments for insomnia to determine impacts on adherence rates and sleep/wake patterns. A novel treatment, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I) was compared to standard treatment, Cognitive Behavioral Therapy for Insomnia (CBT-I). The results showed that ABC-I was non-inferior to CBT-I and adherence to the treatments was similar in both groups. These results improve the repertoire of available behavioral treatments for insomnia within VA by showing that a new treatment, called ABC-I, works as well as standard CBT-I.
The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of evidence-based therapies in comparison to a wait-list control and evaluate the relative contribution of exposure, cognitive, and skills blocks of treatment in a 16-session manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans. Hyp1: Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD symptoms than the skills component. Significant results will establish the efficacy of a group format for evidence-based treatments for all veterans with a PTSD diagnosis. An ancillary part of the study is to examine initial neuropsychological presentation in this population and possible changes that may occur as the result of treatment.
The overall aim of this pilot feasibility study is to determine if 12-week moderate intensity exercise can safely alleviate posttraumatic symptoms in premenopausal women veterans. Specific aims of the study are to; 1. Determine the feasibility, safety, and tolerability of 12-week moderate intensity exercise 2. Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome data will include posttraumatic and depressive symptoms. 3. Explore potential therapeutic effects of a 12-week moderate intensity exercise on comorbid pain syndrome and quality of life.
Little is known about the long-term health and mental health status of women Vietnam veterans. For many of these women, the effects of this war are still present in their daily lives. As these women approach their mid-sixties, it is important to understand the impact of wartime deployment on health and mental health outcomes nearly 40 years later. The investigators propose to assess the prevalence of posttraumatic stress disorder (PTSD) and other mental and physical health conditions for women Vietnam veterans, and to explore the relationship between PTSD and other conditions and the Vietnam deployment experience. The investigators are interested in studying women Vietnam veterans who may have had direct exposure to traumatic events. For the first time, the investigators also want to study those who served in facilities near Vietnam. These women may have had similar, but less direct exposures. This cross-sectional study will seek to contact approximately 10,000 women for participation in a mailed survey, telephone interview and a review of their medical records. Women identified as serving in Vietnam, near Vietnam (in Asia during the Vietnam Ware) and in the U.S. during the Vietnam War will be identified from an established cohort and sent a survey on demographics, behaviors, disability, health-related quality of life, and medical conditions. Women agreeing to be contacted will also be interviewed by study investigators using the modified CIDI to ascertain current and lifetime mental health conditions (including PTSD) and exposure to traumatic events. A more extensive chart review will be conducted by a clinician to validate self-report of key medical conditions.
The purpose of this study is to examine the efficacy of a gender-focused addiction treatment model (A Woman's Path to Recovery) versus a non-gender focused addiction treatment model (12-Step Facilitation) in a sample of women Veterans with substance use disorder.
Intimate partner violence (IPV) is a major health concern for women Veterans. IPV is associated with numerous physical and mental health conditions. VHA is implementing IPV screening programs to identify female patients who experience past-year IPV. Despite strong evidence that screening increases detection of IPV, less is established about how to intervene following IPV disclosure in health care settings, in order to improve health outcomes. Existing healthcare-based interventions result in minimal effects on health and well-being, likely because they are too brief and generic. In response, the PI has developed Recovering from IPV through Strengths and Empowerment (RISE), based on the IPV-related health care needs and preferences of women Veterans. RISE is designed to be delivered in primary care and is an individualized, variable-length, modular-based intervention that addresses * safety planning; * education on the health effects of IPV and warning signs; * increasing coping skills and self-care; * enhancing social support; * making difficult decisions; and * connecting with resources. This study is aimed at refining and evaluating RISE for use with female VA patients who have experienced past-year IPV. This brief counseling intervention is intended to be administered in conjunction with primary care, as this is a frequent point of healthcare contact for women Veterans and where disclosure of IPV is most prevalent.
Lifetime sexual trauma (ST) (i.e., behaviors that range from unwanted sexual touching to attempted or completed rape) is a significant social and public health problem among women Veterans. For women Veterans, lifetime ST can occur prior to, during or after military service. ST is associated with multiple difficulties and risks, including posttraumatic stress disorder (PTSD), intimate partner violence (IPV), and alcohol misuse. Providing an effective, integrated, and low-cost intervention that targets ST-related risks for women Veterans with lifetime ST would advance clinical care for these vulnerable women. This research will develop and assess a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will be designed to provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting. Primary care visits are frequent points of health care contact for women Veterans making the visit itself the ideal, and possibly only, opportunity to provide behavioral interventions. This study will lay the groundwork for a larger clinical trial of the SHE program in multiple VA primary care settings. If effective, the intervention, SHE, represents an innovative and low cost service for early identification and intervention that could be implemented nationwide with ease and speed to address the needs of women Veterans with lifetime ST. The long-term goal of the project is to make a significant impact on advancing health services research by introducing and testing a novel and potentially powerful service tool that may improve service delivery to address the co-occurring health concerns for women Veterans with any lifetime ST.
The purpose of this study is to evaluate a Female-Specific Cognitive Behavioral Therapy (CBT) Group as treatment for Alcohol Use Disorder among Veteran women.
The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.