Eating Disorder

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

Researchers are evaluating the feasibility and preliminary clinical outcomes of a personalized digital treatment designed for adolescents with eating disorders aged 15 to 18 years. The study aims to understand who benefits from this digital approach, how acceptable and credible it is to participants, and the cost-effectiveness of delivering such treatment in routine child and adolescent psychiatric outpatient care. The intervention includes a therapist-guided digital program consisting of 8 modules delivered over 10 weeks, with weekly therapist contact. Participants will complete self-report questionnaires before, during, and after the treatment, as well as at 3- and 6-month follow-ups. The study also involves semi-structured phone interviews with some participants to explore their experiences with the treatment. Participants will be asked to complete various validated questionnaires assessing eating disorder symptoms, general psychopathology, quality of life, and treatment satisfaction throughout the study period. Adherence to the treatment and participant experiences will be monitored, along with health and social outcomes such as school attendance and emotional regulation. Data collection occurs online, and the total follow-up extends to six months after treatment completion.

Suicide is the second leading cause of death among youth, and rates in the US are rising despite prevention efforts. Researchers are evaluating a digital platform called Vira to improve how care is delivered to adolescents at high risk for suicide. This platform aims to use smartphone data and secure communication tools to better understand and manage risk factors like psychological distress, anhedonia, behavioral withdrawal, and sleep problems in young people receiving intensive outpatient treatment. The study compares two groups of adolescent patients aged 13 to 18 years old who are in an intensive outpatient Dialectical Behavior Therapy DBT program. One group uses the Vira platform, which collects data passively from smartphone sensors about activity, sleep, mobility, and mood-related language. Vira also prompts daily check-ins and supports practitioners with reminders to encourage behavior changes. The other group receives the usual treatment with the addition of a passive monitoring app called EARS. Participants will use their assigned app during their intensive outpatient treatment. Researchers will assess outcomes using tools like the Columbia Suicide Severity Rating Scale and Scale for Suicidal Ideation over six months. Other measures include anxiety, risky behaviors, sleep quality, mood, and pleasure scales at three and six months. The study monitors clinical outcomes to determine if the digital platform enhances care for youth at risk of suicide.

Researchers are evaluating the ViraSafe app, an enhanced version of the BRITE suicide safety planning app, to improve engagement with coping skills and safety planning among suicidal adolescents aged 13 to 24. This pragmatic randomized trial compares the new ViraSafe app integrated into the Vira behavior change platform with the original BRITE app, aiming to address rising youth suicide rates by using digital tools for intervention. The study focuses on youth who have experienced recent suicidal thoughts or attempts and are receiving care in clinical settings. Participants are randomly assigned to use either ViraSafe or BRITE. ViraSafe integrates safety planning and coping skills into a smartphone app with automated just-in-time reminders and daily distress ratings, supported by clinicians who can send additional nudges. The BRITE app offers self-monitoring, a safety plan, distress level ratings, and suggested coping activities based on distress. Both groups onboard the assigned app with a trained clinician or research staff. The trial lasts three months with assessments at baseline, one month, and three months. Participants complete virtual assessments including interviews and self-report measures at baseline, one month, and three months. Some participants using ViraSafe will take part in qualitative exit interviews for feedback. The study collects data on app engagement, technology acceptance, and suicide risk factors using standardized tools. Safety plans remain accessible throughout, and mental health indicators are monitored through self-reports and passive smartphone data. The total participation time is about three months, with ongoing support from clinical providers.

Researchers are studying Severe and Enduring Eating Disorders SEED, which are long-lasting eating disorders affecting adolescents and adults. The study aims to understand the clinical, psychological, and biological factors that contribute to the development and persistence of SEED. It follows two groups of patients, one aged 14-17 and one aged 18 and older, to observe changes and impacts over time. Participants will be followed at multiple points at the start baseline, after treatment, two years later, and then at five, 10, and 20 years after baseline. During these times, they will undergo physical exams, provide blood samples, participate in interviews, and complete questionnaires. Caregivers of minors will also complete questionnaires. The study collects extensive data on psychiatric symptoms, personality, emotion regulation, loneliness, and inflammatory markers. Throughout the study, participants will be assessed with various interviews and questionnaires to measure eating disorder symptoms, psychosocial functioning, quality of life, and biological markers. Weekly weight checks occur during treatment and follow-up. Researchers will analyze how different factors influence the course of the disorder and treatment outcomes. The study may last up to 20 years for some participants and includes regular digital questionnaire responses and registry data reviews.

Researchers are evaluating a mentalization-based prevention program aimed at improving well-being and mental health in children aged 8 to 10 years and their families across four European countries Germany, Lithuania, Spain, and Switzerland. The study is designed as a partially randomized controlled trial and investigates how multi-level interventions involving children, parents, and teachers can promote mental health, reduce stigma, enhance help-seeking behavior, and improve classroom climate and parenting skills. The program includes a universal prevention workshop delivered at schools for all children, focusing on mental health awareness and peer support skills. Parents receive one of two different intervention trainings or a parenting guidebook one group attends 10 weekly sessions of the Lighthouse Program targeting secure attachment and reflective parenting behaviors, and another group participates in 6 bi-weekly Mentalization Based Skills Training sessions focusing on attentional control and emotion regulation. An active control group receives a parenting guidebook, while a passive control group participates in follow-up assessments without intervention. Participants will be involved in data collection at multiple time points baseline, post-intervention at 3 months, and follow-ups at 6 and 12 months. Assessments include questionnaires measuring childrens and parents well-being and mental health, parental efficacy and stress, classroom climate, teaching efficacy, and mental health stigma. Focus groups after the post-assessment will gather feedback on implementation and satisfaction. The study aims to follow 5,000 children, their parents, and teachers over a year to evaluate long-term program effects.

Researchers are evaluating the effects of a smartphone-based Healthy Lifestyle HLS intervention on the mental and physical health of firefighters in Tainan, Taiwan. This cluster randomized controlled trial aims to determine if the Traditional Chinese version of the HLS mobile app can improve firefighters health compared to usual care. The study also seeks to find out whether the intervention can promote a healthier lifestyle and reduce the risk of chronic non-communicable diseases among firefighters. Participants will be randomly assigned to either the intervention group, which uses the Traditional Chinese HLS mobile app designed specifically for firefighters, or the control group, which receives usual care. The intervention period lasts from 3 to 6 months, during which firefighters in the intervention group will use the app to support healthier behaviors. The control group will continue with their standard practices without the app. Throughout the study, firefighters will undergo health and fitness assessments at the start and again 3 to 6 months after the intervention begins. Measurements include blood pressure, depressive symptoms, PTSD symptoms, body mass index, smoking habits, diet patterns, physical activity levels, sitting time, sleep duration and napping frequency, glycated hemoglobin, lipid profiles, C-reactive protein, and physical performance. The study will monitor these outcomes to assess changes in mental and physical health. Safety and progress will be observed through these regular evaluations during the study period.

Researchers are studying the effects of a low-protein diet on cancer patients receiving immunotherapy treatments. The study aims to see if reducing protein intake can change the tumor environment and boost the bodys immune response, potentially enhancing the effects of immune checkpoint inhibitors. This is a randomized, open-label study conducted at a single center to explore the feasibility of this dietary approach. Participants will be randomly assigned to one of two groups one receiving immunotherapy plus a control diet containing about 20% protein, and the other receiving immunotherapy combined with a low-protein diet containing 10% protein. The study intervention lasts for 4 months, during which the dietary impact on immune response and treatment effects will be evaluated. Throughout the 4-month study period, participants will be monitored for their ability to follow the dietary plan and for any changes in immune response to immunotherapy. Researchers will assess safety, tolerability, clinical efficacy using RECIST v1.1 criteria, and enrollment and drop-out rates. Laboratory tests and imaging scans will also be conducted to evaluate disease progression and treatment impact.

Researchers are studying the effects of intermittent caloric restriction combined with a plant-based diet in cancer patients receiving chemotherapy. This pilot trial aims to assess whether this dietary approach is feasible and safe alongside standard chemotherapy, and whether it may reduce side effects while potentially enhancing the chemotherapys antitumor effects. Participants will follow a protocol involving alternate-day intermittent caloric restriction along with a plant-based protein diet during their chemotherapy treatment. The study evaluates how this combined dietary intervention interacts with standard chemotherapy regimens over the course of treatment. During the study, participants will be monitored for adherence to the dietary plan and chemotherapy treatment. Researchers will assess feasibility over 12 months, including safety and preliminary evidence of clinical efficacy. Evaluations may include health assessments, laboratory tests, and monitoring of side effects throughout the study period.

Researchers are evaluating whether teaching people personalized versus standardized emotion regulation skills can better reduce daily negative emotions. The study also aims to see if matching participants to their predicted best skill training is feasible and helpful. This research may reveal how emotion regulation treatments impact emotional health and help develop personalized, evidence-based, and scalable interventions. Participants will be randomly assigned to learn one of three emotion regulation skillscognitive restructuring, opposite to emotion action, or mindfulnessthat matches their personal strengths, or to learn all three skills through interactive videos with surveys to practice and check understanding. These training conditions are designed to compare focused versus broad skill coverage. During the study, participants will report their emotions multiple times daily for 42 days, using the Positive and Negative Affect Schedule-Short Form. They will also complete assessments every two weeks for six weeks, measuring depression, anxiety, personality traits, responses to emotions, and breath-counting tasks. Researchers will monitor changes in emotion regulation effectiveness and emotional experiences to understand the impact of the training.