Limbitrol

The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their caregivers. The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. We will also examine pre- to post- changes on outcomes for the sole purposes of making sure scores on measures are changing in the hypothesized direction (e.g., depression scores are going from moderate to minimal as opposed to no change or depression scores increasing). Once enrolled in the study, participants complete a baseline survey. Then they will participate in LFAP which is an 8-session group intervention; sessions will be scheduled once a week for eight weeks (at 2 hours per session). Participants will complete survey instruments before and immediately after the program sessions, in addition to post-program surveys and an exit interview.

Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.

The primary objective of this randomized study is to evaluate the effect of a virtual reality (VR) video on pre-treatment anxiety levels in individuals undergoing magnetic resonance-guided focused ultrasound (MRgFUS) treatment for medication-refractory essential tremor (ET). Participants will be randomized to view one of two VR videos, and pre-treatment anxiety levels will be compared between groups. As a secondary objective, the study will compare patient concerns (including claustrophobia, mental preparedness, and fear of pain, as well as any additional concerns identified during the study) between the two randomized groups.

The goal of this clinical trial is to learn if two behavioral interventions work to reduce office disciplinary referrals, improve attendance, and reduce depression and anxiety in 7th grade students. This project combines two evidence-based programs-the Inclusive Skill-building Learning Approach (ISLA) for school-wide discipline reform and the Family Check-Up Online (FCU-O) for family-centered support-in an adaptive design to examine the unique and additive effects of these interventions on these child behavior outcomes. The main questions it will answer are: 1. What is the relative efficacy of ISLA vs. School-as-Usual? 2. What is the optimal sequencing of these interventions? 3. Which overall sequence of intervention strategies was most effective? Researchers will compare 6 combinations of these interventions to see which combination and sequencing provides the best student outcomes. School personnel participating in the project will be trained to implement the two interventions at their school. They will answer surveys in the fall, winter, and spring of their year of participation. Parent and Youth participants will complete surveys at baseline and then again 6 months and 12 months later.

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms. MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

The goal of this study is to evaluate the efficacy and cost-effectiveness of the Living Well Program, a digital therapeutic application with telecoaching support, in breast cancer patients with moderate-to-severe anxiety. The main question the study aims to answer is: does digital cognitive-behavioral therapy-based interventions decrease the overall healthcare costs of patients with stage II to IV breast cancer? The study has one group of participants who will use the Living Well app and telecoaching support. This group will be compared to retroactively matched controls. Over 3 months, patients will complete 21 mental health modules and 5 telecoaching sessions. In the following 3 months, they will complete any outstanding telecoaching sessions and modules while still being monitored, even if they finished all modules and sessions in the first 3 months. The 6 months after that will be the follow-up phase. They will still have access to the Living Well app and may continue to use it, and they will complete the same assessment questionnaires as baseline to identify any changes in their overall mental health.

The purpose of the study is to evaluate a trauma informed digital multicomponent intervention design to improve health and safety outcomes for women with lifetime exposures to violence and co-occurring PTSD and/or depression symptoms

The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth. The main questions this study aims to answer are: * Does using the chatbot improve postpartum pelvic floor health knowledge? * Does using the chatbot help reduce feelings of loneliness during the postpartum period? * Does using the chatbot impact pelvic floor symptoms? Researchers will compare standard postpartum care to standard care plus the chatbot. Participants will: Be assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot. If in the chatbot group, participants will receive education and support via the chatbot over a 4-week period. Both groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress. The chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing facility residents and their primary support person. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. The researchers will compare the InSTILL program to minimally enhanced usual care. Participants will be randomly assigned to receive either the InSTILL program or minimally enhanced usual care. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

The goal of this clinical study is to learn the impact of two Akashic Records sessions on mental health symptoms in adults. We want to see how sessions are linked to stress, anxiety, and depression, and to resilience (ability to bounce back) and feelings of connectedness (to self, community, and humanity). Main questions this study will answer are: After two sessions, what is the impact on stress, anxiety, and depression? After two sessions, what is the impact on resilience and connectedness? How do participants describe their experience of the sessions? After two sessions, what are participants' views of their problems (insight), emotional experiences (impact) and observable behaviors in their daily life? What participants will do: Complete online surveys about their mood at four points: before the first session, before the second session, after the second session, and again 2 months later. Surveys include: DASS-21 (Depression, Anxiety, and Stress Scale) CD-RISC-10 (Connor-Davidson Resilience Scale) WATTS (Connectedness Scale) A short demographic form and satisfaction survey Attend two individual Akashic Records sessions (50-90 minutes each) over private video platform with a licensed clinical social worker (principal investigator) The first 50 participants will also join a one-hour interview with open ended questions with a licensed clinical social worker (co-investigator) about one week after the second session to share their experience in their own words. Who can take part: Adults ages 18 and older who can read and consent in English and who have experienced stress, anxiety, or low mood in the past year. How the research will happen: Sessions are held by secure video call. Participants will also complete private online surveys before, during, and after the sessions. Some participants may be invited to share their experiences in a one-on-one interview. All information is kept private and names are removed before analysis. Risks and benefits: Talking about personal topics may bring up strong emotions. Licensed clinicians conduct sessions, offer support, and provide referrals if needed. Possible benefits include new insights, greater peace or meaning, and improved coping; benefits are not guaranteed. Why this matters: Many people seek spiritual or transpersonal support for emotional concerns. This pilot study will provide early evidence on whether Akashic Records sessions may be a helpful, low-risk option and will guide future research.

The purpose of this study is to compare the effects of enhanced Virtual Reality-Reward Training (eVR-RT) with an active control condition, Virtual Reality-Memory Training (VR-MT), on positive affect and other clinical symptoms. Enhanced VR-Reward Training is a novel intervention aimed at enhancing savoring of positive experiences among individuals with depression and low positive affect through guided imaginal recounting following immersion in positive VR experiences. The current study tests an enhanced version of this training using improved virtual reality technology. Target enrollment is 80 participants with low positive affect, depression, and impaired functioning, who are at least 18 years old, who will be randomly assigned to 7 weeks of either enhanced Virtual Reality-Reward Training (VR-RT) or Virtual Reality-Memory Training (VR-MT). Participants will complete in-person VR sessions, laboratory assessments, self-report questionnaires as part of the study. A subset of 8 participants randomly assigned to VR-RT will complete fMRI scans and EMA surveys. The total length of participation is around 3 months.

This study is again looking at the use of music and music therapy experiences in navigating depression. The researchers will provide 11 sessions of music therapy and half will be followed by recitals at the Third Street School Music Settlement where the kids enrolled in our study will observe and interact with the performers and discuss and reflect on anxiety and performance and how sharing personal creativity affects them intra and interpersonally.