Clinical trials

The goal of this clinical trial is to learn if the FlowMD mobile app is feasible to be used to manage mild anxiety in adults. It will also learn if the app is effective at managing anxiety in adults. Participants will: Use the FlowMD app daily to complete a 1-5 minute guided breathwork session over the course of 4 weeks. Complete surveys at the beginning, midpoint, and end of the study to measure anxiety levels and usability of the app.

Chronic pain is a common condition that can affect sleep, daily functioning, and overall quality of life. Many individuals living with chronic pain seek non-medication approaches to help manage their symptoms. Weighted blankets are commonly used to promote relaxation and comfort during sleep, but there is limited research examining their potential role in supporting people with chronic pain. This pilot study will explore the experiences of adults with chronic pain who use a weighted blanket during sleep. The study aims to better understand whether nightly use of a weighted blanket may be associated with changes in pain, sleep, and daily functioning. Findings from this study will help inform future research on non-medication approaches to managing chronic pain. Approximately 44 adults with chronic pain will participate in the study. Participation will last about five weeks. After completing a virtual enrollment visit and baseline questionnaires, participants will receive a weighted blanket sized to approximately 10 percent of their body weight. Participants will first complete a 7-day adjustment period using the blanket while sleeping. If they tolerate the blanket and use it nightly during this period, they will continue into a 4-week study phase in which they will use the weighted blanket each night. During the study, participants will complete brief online surveys about their experiences and adherence to using the blanket. Pain and quality-of-life questionnaires will be completed at multiple time points, including at the start and end of the study. Participants will also provide feedback about their experience using the weighted blanket. Results from this pilot study will help researchers better understand how weighted blankets may be used by adults with chronic pain and may help guide the design of future studies evaluating non-pharmacologic approaches to pain management.

Ulcerative colitis (UC) is a long-term condition that causes inflammation in the large intestine. People with UC often have symptoms such as diarrhea, abdominal pain, and fatigue. These symptoms can come and go over time and can have a major impact on daily life. Although there are many medical treatments available, some patients do not respond well, experience side effects, or prefer to avoid long-term use of medications that affect the immune system. Because of this, many people with UC seek care from naturopathic doctors. This study aims to better understand how naturopathic care is used to treat UC and whether patients experience changes in their symptoms over time. In this study, adults with UC who are already receiving care from a naturopathic doctor will be followed for 12 weeks. The treatments will not be standardized; instead, each naturopathic doctor will provide individualized care based on their usual practice. Participants will complete a questionnaire that measures UC symptoms at the start of the study and again after 12 weeks. The study will compare symptom scores before and after treatment. Researchers will also collect information about the types of treatments used and any side effects or adverse events. This is an observational study, meaning there is no comparison group and no changes are made to participants' usual care. The goal is to gather early information about naturopathic care for UC and to help guide future, more rigorous studies.

The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort with physical activity and support function, and motivational interviewing to strengthen motivation, confidence, and the ability to make healthy changes. The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews. The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.

Small intestinal bacterial overgrowth (SIBO) can cause symptoms like bloating, stomach pain, and changes in bowel movements, significantly affecting quality of life. Many people with irritable bowel syndrome (IBS) also have SIBO, and there is growing recognition of how important it is to address this condition. Artemisia annua has shown potential in managing SIBO based on early reports and studies suggesting it can fight bacteria like \*E. coli\* and \*Klebsiella\*, which are linked to a type of SIBO that produces hydrogen gas. This study aims to test if Artemisia annua is safe and well-tolerated for adults with hydrogen-type SIBO. Over five weeks, participants will take either 5 grams of dried Artemisia annua leaves or a placebo. Researchers will monitor safety through blood tests, vital signs, and adverse events, and they will assess symptom changes using questionnaires and breath tests. The trial will include up to 32 participants from the Portland, Oregon area. Participants will be randomly assigned to treatment groups, and neither they, the researchers, nor the test administrators will know who is receiving the herb or the placebo. Results will be analyzed using standard statistical methods. This study addresses the lack of research on herbal treatments for SIBO. If successful, the findings could lead to larger studies and help expand treatment options for people with SIBO.

Irritable bowel syndrome (IBS) is a common condition affecting about 4% of people worldwide and can significantly impact quality of life and healthcare costs. While there are medications available, few are consistently effective, leading many people with IBS to explore alternative treatments, including naturopathy. However, research on naturopathic approaches to IBS is limited. This study aims to describe how naturopathy is used to treat IBS and to collect preliminary data on changes in IBS symptoms before and after treatment. It will use a prospective, observational design without a control group, focusing on outcomes from individualized naturopathic care provided by licensed practitioners. Adult patients with diagnosed IBS or IBS-like symptoms will be recruited from naturopathic doctors affiliated with the Gastroenterology Association of Naturopathic Physicians. Participants' IBS symptoms will be assessed using validated tools (IBS-SSS and IBS-AR), and quality of life will be measured using the PROMIS-29 survey. Treatment details and any adverse effects will also be recorded. The main outcome will be the difference in symptoms and quality of life after 12 weeks of treatment. Results will be analyzed with statistical tests (p-value \< 0.05) and summarized. The findings from this pilot study will help fill knowledge gaps and provide a foundation for designing a more rigorous randomized controlled trial in the future.

The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system.