Norpramin

This study is a randomized, double-blind, placebo-controlled, within-individual crossover trial designed to assess the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend (FODZYME®) on gastrointestinal symptoms in adults with self-reported bloating.1 The study's rationale is based on the fact that fermentable carbohydrates (FODMAPs) are often poorly absorbed and can trigger symptoms like bloating and abdominal pain. While a Low FODMAP Diet (LFD) is clinically validated for symptom relief, it is restrictive. The enzyme blend is intended to offer a more flexible, enzyme-based solution by targeting and breaking down FODMAPs, such as fructan, GOS, and lactose, before they ferment in the colon. The primary objective is to evaluate the product's impact on bloating symptoms, measured by the mean PROMIS scale Gastrointestinal Gas and Bloating score. Secondary and exploratory objectives include assessing the impact on overall gastrointestinal symptom severity (IBS-SSS), abdominal pain (PROMIS Belly Pain score), food-related quality of life (FR-QoL-29), and anxiety (GAD-7 scores). The study also aims to evaluate these effects across various Irritable Bowel Syndrome (IBS) subgroups (IBS-C, IBS-D, IBS-M). The trial is a consumer-driven, decentralized research study utilizing validated patient-reported outcome measures that can be completed in a home setting.

Depression is the leading cause of disability worldwide, affecting an estimated 300 million people. Despite available treatments, response rates remain modest, and treatment resistance is common. Novel treatments are needed that act rapidly, produce lasting effects and work differently than existing antidepressants. In clinical trials, psilocybin has shown promise as a treatment for depression due to its rapid onset of antidepressant effects and sustained benefits. This study will use MRI scanning of the brain and other biological measures (biomarkers) to investigate how psilocybin affects brain activity and psychological flexibility before, during, and after receiving psilocybin in participants with depressive symptoms.

The purpose of this study is to determine if the addition of digital sensing data collected from phones and watches during the early stages of perinatal depression (PND) treatment can better predict treatment outcomes than using self-reported symptoms alone.STAND for PND: The UCLA Depression Grand Challenge (DGC) has previously developed a technology-assisted, scalable therapy system called STAND (Screening and Treatment for ANxiety and Depression) for perinatal depression (PND) and has demonstrated in an initial randomized clinical trial that this treatment intervention to be as effective as psychiatrist delivered care for PND. In this study, the investigators will administer STAND for PND for up to 12 weeks as part of study participation. There will be no comparison between our treatment intervention and a treatment as usual condition, as this is not a trial of efficacy. In the STAND for PND treatment model, women with moderate symptoms will be routed to coach-guided, digital cognitive behavioral therapy (CBT) tailored to PND, which has been demonstrated to be an effective treatment approach for PND. Women with severe depression or suicidality will be routed to clinician delivered CBT, with pharmacotherapy as needed, with both CBT and pharmacotherapy demonstrated to be effective treatment approaches for PND. Symptoms will be regularly monitored throughout the intervention period. Digital Sensing in Depression: The DGC also has substantial experience in large-scale longitudinal digital sensing studies, and experience identifying associations between self-report or clinical ratings of depressive symptoms and digital sensing features, including in pregnant and postpartum women. Digital Sensing in a STAND for PND study: In our previous STAND for PND study, the investigators did not include digital sensing. In this next phase of our research program, the investigators will collect digital sensing data from phones and watches during the first four weeks of study participation. The investigators will enroll up to 250 women during their last trimester or who are in the postpartum period to participate in the 12-week study, which includes treatment provided through the STAND for PND program of care and during which the investigators will obtain 4-weeks of digital sensing data.The investigators will be testing whether behaviors measures through digital sensing (i.e., digital features) in combination with self-reported depression symptoms will better predict treatment outcomes than the self-reported depression symptoms alone. The investigators are testing the hypothesis that prospective longitudinal assessments using digital devices will enhance our ability to predict outcomes of STAND-PND.This project is part of a larger program of research that aims to improve clinical decision-making for PND by establishing a clinical care model for PND that fully integrates digital sensing with digital therapy. An additional objective of this program of research is to target low-income mothers from populations that have had limited access to mental healthcare, given that this population is particularly vulnerable to the impact of PND.

The goal of this study is to understand why certain treatments help people reduce repetitive negative thinking (RNT), which is common in many mental health problems. We want to: 1. Figure out what actually causes repetitive negative thinking to decrease when people use cognitive-behavioral therapy (CBT). 2. Find out which parts of RNT-focused CBT are the most important - the parts that truly make a difference in reducing RNT. The main result we will look at is how much a person's repetitive negative thought patterns change from the start of the study to the end of treatment (16 weeks). We will measure this using the Perseverative Thinking Questionnaire at baseline and week 16.

The goal of this clinical trial (single-arm pilot trial) is to learn whether a mobile application-based mindfulness intervention can improve mental health outcomes in older Korean immigrants aged 60 years and older. The main questions it aims to answer are whether the 8-week mobile app-based mindfulness intervention is feasible and acceptable, as indicated by recruitment, retention, and adherence rates, and whether participation in the intervention leads to improvements in positive psychological well-being (e.g., positive affect, optimism, life engagement, and mindfulness) and reductions in adverse mental health outcomes (e.g., anxiety, depressive symptoms, and perceived stress). Participants will complete baseline and post-intervention assessments, receive training on how to use the mobile mindfulness application, engage with the app for approximately 8 weeks (recommended 10-15 minutes per day), and participate in weekly check-ins to support engagement and address any challenges encountered during the intervention.

The goal of this clinical trial (single-arm feasibility study) is to examine the feasibility, acceptability, and preliminary efficacy of a mindfulness-based, app-delivered intervention to address mental health and emotion regulation challenges in young adults with early life adversities (ELAs). The main questions it aims to answer is: \- Will young adults find the Growth, Empowerment, and Mindfulness (GEM) intervention to be both feasible and acceptable, as demonstrated by participants' engagement and quantitative/qualitative feedback? Additionally, it aims to answer: * Will GEM intervention demonstrate preliminary efficacy in improving outcome measures including depression, anxiety? * Are improvements in mindfulness and sleep, as well as reductions in rumination, mechanisms of action underlying the improvements in psychological and behavioral outcomes of the intervention? Participants will be asked to: * participate in GEM, which integrates app-based intervention content, formal and informal mindfulness practices, weekly Zoom group sessions, and ecological momentary intervention (EMI) delivery * complete baseline, post-intervention, and 3-month follow-up assessments * complete weekly assessments and daily ecological momentary assessments (EMAs) during the intervention delivery * wear Fitbit for researchers to collect sleep-related data

Symptoms of depression are highly prevalent among Veterans. However, fewer than 30% of individuals with these symptoms receive any psychotherapy in the Veterans Health Administration (VHA). This is due to many factors, which may include provider availability and patient preferences. Guided self-help (GSH), which involves coaching sessions with patients who are following a fully developed self-help program, has the potential to increase access to care for these Veterans, particularly if implemented within a stepped care model of mental health treatment delivery and if delivered by a diverse set of providers. The VHA's primary care-mental health integration (PCMHI) service, which focuses on short courses of care for mild to moderate symptoms, may be an ideal place in which to deploy GSH. The current project seeks conduct a pilot randomized trial of a GSH program for depression adapted for PCMHI based on behavioral activation.

The goal of this clinical trial is to learn if a combination of non-drug treatments works to benefit memory, thinking, and brain functioning in older individuals with recurrent depression. The non-drug approaches the investigators are studying include transcranial direct current stimulation (tDCS) and computerized cognitive training. tDCS uses small currents of electricity on the forehead to potentially stimulate your brain's ability to process and learn. Computerized cognitive training uses tablet games to improve memory and thinking. In this study, two different cognitive training programs are being investigated, both of which are stimulating and designed to engage brain activity. One that is believed to be a specific treatment for depression, while the other provides extra stimulation for the brain that is non-specific. Two different tDCS parameters - active stimulation and sham (or placebo) stimulation - are also being investigated. Participants will be randomized to one of three study groups: 1. Depression cognitive training treatment with active brain stimulation 2. Depression cognitive training treatment with sham brain stimulation 3. Non-specific cognitive training treatment with sham brain stimulation The main questions this clinical trial aims to answer are: * Does "depression cognitive training treatment with active brain stimulation" benefit thinking and memory more so than the other treatments? * Does "depression cognitive training treatment with active brain stimulation" benefit brain functioning more so than the other treatments? Participants will: * Complete several baseline and post-intervention visits at the research center for checkups and tests over the course of 3-4 months. * Visit the research center daily for 4 weeks to complete their assigned treatment.

Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options. Possible Benefits: Previous studies have showed a 70% remission rate for depression symptoms. It is possible that participants could have improvement in depressive or concussive symptoms after the ONE-D TMS treatment.

The aim of this trial is to evaluate the feasibility and preliminary efficacy of using passive smartphone sensors to detect moments of heightened negative mood and inform the timing of brief mental health interventions, such as mindfulness exercises and psychoeducation, in adults with early psychosis.

The goal of this hybrid implementation-effectiveness study is to learn about the effectiveness and appropriateness of "Trauma-Informed and Culturally-Responsive Integrated Massage Therapy" (TCI-Massage) for torture and war trauma survivors. The study aims are: • Examine the uptake of TCI-Massage within CVT by assessing key implementation science outcomes of acceptability and appropriateness among refugees and asylum seekers from diverse cultural backgrounds. • Examine the integration of massage therapy into the current psychosocial care model used at CVT. • Examine the effectiveness of TCI-Massage for torture and war trauma survivors to reduce distress (mental health symptoms, chronic pain, and HRV) and improve coping (interoceptive awareness and social functioning). Treatment group participants will participate in psychosocial care services + TCI-Massage, which the control group will only participate in psychosocial care services

This study is an open trial designed to examine individual changes that occur before, during, and after 6 modules of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.