Veterans

Veterans face a heightened risk of suicide during the first year after leaving military service, especially those not connected to VA healthcare. This research aims to improve reintegration and reduce suicide risk for recently transitioned Veterans by evaluating STEP-Home-SP, a skills-based, video telehealth workshop. It is designed to provide suicide prevention education, support for accessing VA care, and tools to manage the transition effectively during this critical period. The study compares two groups: one participating in the STEP-Home-SP workshop and the other receiving Enhanced Usual Care (EUC), which includes standard care plus an educational packet on suicide risk and VA care connection. STEP-Home-SP involves weekly 1.5-hour group sessions over 12 weeks, focusing on emotional regulation, problem solving, and attention training, with up to six additional 30-minute individual sessions tailored to each Veteran's needs. EUC involves existing transition support programs such as the Transition Assistance Program and VA Solid Start outreach. Participants will be assessed at multiple points over a year, including baseline, 12 weeks, and 24 weeks. Researchers will measure feasibility factors like recruitment and adherence, satisfaction with the program, and changes in reintegration status using the Military-to-Civilian Questionnaire. They will also monitor engagement with VA care and collect qualitative feedback. The study will help inform future larger trials and aims to address social isolation and suicide risk during Veterans' transition to civilian life.

Researchers are evaluating the effectiveness of an adaptive web-based intervention called Partners Connect to address drinking behaviors in military spouses and encourage help-seeking among service members. The study aims to find out for whom this intervention works best and which drinking behaviors and mechanisms are affected. It compares the web-based intervention with other resources and phone-based or workbook-guided Community Reinforcement and Family Training (CRAFT) methods. Participants are assigned to different groups: some receive the CRAFT web-based intervention focused on mental health, relationship communication, and positive reinforcement; others use self-guided resources from a website; if a dyad member does not respond, they may be randomized to phone-based CRAFT sessions or guided by a CRAFT workbook. The interventions include digital storytelling, exercises, and clinician sessions to support behavior change and communication. During the study, participants are monitored from the start through six months, with measures of partner drinking days, drinks per episode, and service member help-seeking. The study tracks mental health symptoms and collects data through surveys and reminders to assess website use. Participants are expected to engage with the interventions and complete follow-up assessments to help researchers evaluate the impact of these approaches on drinking and help-seeking behaviors.

Researchers are evaluating the effectiveness and safety of pacritinib in people with VEXAS syndrome, a rare inflammatory condition caused by specific genetic mutations. This randomized, placebo-controlled phase 2 trial aims to prevent flares of VEXAS symptoms after reducing glucocorticoid (GC) treatment. The study will include adults aged 18 and older who have been on stable GC therapy for at least four weeks and have inflammatory involvement of various organs linked to VEXAS syndrome. Participants will be randomly assigned to one of three groups: pacritinib dose A, pacritinib dose B plus placebo, or placebo alone, all taken orally for up to 24 weeks without knowing which they receive. After this double-blind period, all participants will have the option to receive open-label pacritinib for up to 48 weeks. Those benefiting from pacritinib may continue treatment for an additional year in an extension period. If a participant stops treatment, they will be followed for 30 days after. Throughout the study, participants will have regular assessments to monitor clinical response, flare frequency, blood parameters, and quality of life using patient-reported questionnaires. Blood tests will measure drug levels and inflammation markers like C-reactive protein, erythrocyte sedimentation rate, and ferritin. The main outcome is overall clinical response by week 24. Safety and efficacy data will be collected until about two years after the first dose of the last participant.

Researchers are studying how art therapy affects emotional expression and regulation in military service members with posttraumatic stress symptoms. The study aims to understand the neurological systems involved by using brain scans and self-assessment questionnaires. This research is conducted within the Military Health System where art therapy is a common treatment but lacks thorough scientific evaluation. Participants will attend a total of eleven sessions over six to eight months. The first session includes an interview, self-assessment questionnaires, and a brain MRI scan while viewing neutral and negative images. Then, participants take part in eight one-hour individual art therapy sessions with a certified art therapist. The tenth session repeats the questionnaires and MRI scan, and the final session is a virtual interview conducted three months after the tenth visit. Throughout the study, participants will complete various questionnaires measuring symptoms and traits related to posttraumatic stress, anxiety, stress, and emotional regulation. Brain activity during tasks will be assessed through functional neuroimaging. The research also monitors potential emotional distress during sessions and collects qualitative feedback. Overall participation lasts up to eight months with follow-up to evaluate lasting effects.

Researchers are studying ways to improve access to evidence-based treatments for eating disorders, specifically Bulimia Nervosa and Binge Eating Disorder, among active duty Service members and Veterans. This trial compares two types of cognitive behavioral therapy (CBT) delivered virtually or as self-help, aiming to reduce binge eating frequency and improve mental health outcomes. The study also seeks to inform VA Clinical Practice Guidelines to better serve diverse and underrepresented populations affected by eating disorders. Participants will be randomly assigned to one of two groups: Telehealth Cognitive Behavioral Therapy (TeleCBT) or Self-Help Cognitive Behavioral Therapy (shCBT). TeleCBT involves 8 to 10 individual sessions conducted by a master's-level clinician over three months using an approved video platform. The shCBT group will receive the same treatment materials by mail and complete one chapter per week independently over 12 weeks. Both treatments use the same CBT manual adapted for Veterans. During the study, participants will have assessments at baseline, 3 months (post-treatment), and 6 months to measure changes in binge frequency using interviews and questionnaires. Additional evaluations will track depression, PTSD symptoms, overall wellness, and participant engagement and satisfaction. Researchers will monitor progress via surveys and clinical interviews to understand treatment effects and support future implementation. The total participation duration spans at least six months, including follow-up evaluations.

Researchers are conducting a multicenter observational study to describe the health-related quality of life (HRQoL) and symptom profiles of adult patients with VEXAS syndrome. The study also aims to investigate financial toxicity and how well patients tolerate treatments. To provide context, the data collected from VEXAS patients will be compared with a matched group of patients with myelodysplastic syndromes (MDS). The overall goal is to create benchmark HRQoL data that can support future prospective studies and help design clinical trials. Participants will complete quality of life questionnaires, including the EORTC QLQ-C30 and FACIT-Fatigue assessments, at a single time point after enrolling in the study. There are no drug treatments or interventions being tested, as this is an observational study focused on assessing patient-reported outcomes and financial impacts. The study collects data at one time only, without follow-up treatment phases. During the study, participants will provide information through questionnaires that assess their quality of life, fatigue levels, and financial burdens related to their condition. Researchers will analyze these results by age and sex groups and compare them with matched patients who have MDS. The study is expected to end in September 2025, and all data collection occurs at study entry without long-term follow-up.

Researchers are evaluating hyperbaric oxygen therapy (HBOT) as a potential treatment for mild to moderate traumatic brain injury (TBI) in Veterans and active military personnel. This randomized, placebo-controlled, quadruple-blinded Phase 3 trial aims to determine if HBOT reduces neurobehavioral symptoms, the number of sessions needed for symptom improvement, and whether it lessens posttraumatic stress disorder (PTSD) symptoms. Additional exploratory goals include assessing changes in cognitive function, inflammation markers, microbiome, EEG, sleep, and brain imaging. Participants will receive 40 sessions of either HBOT or a placebo treatment within 12 weeks. The HBOT group will undergo treatment in a chamber pressurized to 2 ATA with 100% oxygen for 60 minutes per session. The placebo group will be in a chamber at normal atmospheric pressure with 21% oxygen. Blood pressure, breathing rate, pulse, and glucose levels (if diabetic) will be monitored during each session. Assessments will be conducted every 5 and 10 sessions, including self-reports and physical exams. After completing the treatment sessions, participants can learn which group they were in and those in the placebo group may have the option to receive the actual HBOT. Participants will complete baseline assessments, including questionnaires, interviews, cognitive tests, blood draws, and physical exams, to confirm eligibility. Mid-treatment and post-treatment visits will reassess symptoms and collect blood samples. Outcome measures focus on changes in neurobehavioral symptoms and PTSD at two weeks post intervention. The study includes monitoring for safety and symptom changes throughout, with regular evaluations of participant well-being and treatment effects over the trial duration.

This research aims to test how well a Smart Bassinet can prevent or reduce postpartum mood disorders by improving sleep for mothers and their infants. The study focuses on military-affiliated pregnant women and compares the Smart Bassinet to a standard commercially available bassinet. The trial explores the effects on infant and maternal sleep, maternal mood symptoms, immune function, and epigenetic markers linked to postpartum depression over six months. Participants will be randomly assigned to use either the Smart Bassinet, which responds to a baby's fussing with swaying and shushing sounds to soothe the infant, or a standard Halo Bassinest without these features. The study lasts six months postpartum, with mothers completing monthly online surveys and collecting sleep data using actigraph devices. Blood samples will be taken at enrollment and at three and six months postpartum to assess immune markers. Mothers will participate by filling out monthly questionnaires about sleep and mood and using sleep tracking devices for one week each month for both themselves and their infants. Blood samples will help evaluate immune system changes over time. Researchers will measure maternal mood, infant and maternal sleep patterns, and inflammation markers. The study also includes genetic testing to see if the Smart Bassinet influences known risk factors for postpartum depression.

This research focuses on veterans at higher risk for esophageal adenocarcinoma (EAC) and its precursor, Barrett's esophagus (BE), due to factors like age, gender, obesity, smoking, and family history. Current guidelines recommend screening only for those with reflux symptoms, but many patients who develop EAC do not report such symptoms. This study evaluates a non-endoscopic screening method to detect BE in veterans without chronic reflux but with multiple risk factors, aiming to improve detection rates and reduce the need for costly endoscopy. Participants will undergo a non-endoscopic test called Esocheck, which collects esophageal tissue samples analyzed by the Esoguard assay for specific biomarkers linked to BE. Those eligible have no history of GERD and have at least three risk factors such as white race, male gender, obesity, smoking history, or family history of BE or EAC. After the Esocheck test, all participants will be offered a standard upper endoscopy (EGD) on the same day to confirm findings and provide diagnostic comparison. During the study, participants will provide informed consent and complete both the Esocheck screening and upper endoscopy. Researchers will analyze tissue samples for biomarker presence and compare results with endoscopy findings to assess sensitivity and specificity. They will also track acceptance rates and reasons for refusing screening. The primary outcome is the confirmation of BE or EAC diagnosis within 10 to 30 days. The study plans to enroll 400 veterans aged 40 to 85 without prior endoscopy and monitor results to improve future screening recommendations.

VEXAS syndrome is a recently identified disorder caused by changes in the UBA1 gene in blood-forming cells, leading to severe blood and inflammation problems. Patients often suffer from disabling inflammatory symptoms and currently have no standard treatments. Researchers are studying pacritinib, a drug that blocks specific enzymes (JAK2 and IRAK1), to see if it can safely reduce symptoms and improve blood counts in people with this syndrome. This phase 1 study involves a single group of patients treated with pacritinib by mouth twice daily in 28-day cycles for up to 12 cycles. The study starts with a small safety phase where 6 patients receive a 200 mg twice daily dose. If this dose is well tolerated, more patients will join to gather more safety and effectiveness data. If too many side effects occur, the dose may be lowered to 100 mg twice daily or the study may be stopped. Participants will be closely monitored throughout the treatment cycles with regular blood tests to measure blood cells, inflammation markers, and gene changes. Researchers will track side effects and improvements in symptoms using the VEXAS Disease Activity Index. After treatment, participants will be followed for up to 24 months to observe the time until next treatment is needed. The total study duration varies but includes treatment and long-term follow-up periods to assess safety and benefits.