Anorexia Nervosa

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 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 the safety, tolerability, how the body processes, and early effects of SXRN Injection in cancer patients suffering from anorexia-cachexia. This clinical trial has two phases: Phase Ia is a single-arm, open-label study with dose escalation, and Phase Ib extends the study by combining SXRN Injection with standard anti-tumor therapies in cancers like pancreatic cancer, non-small cell lung cancer, and colon cancer. The study is sponsored by Jiangsu Nutai Biologics Co., Ltd. and Jiangsu GQ Co., Ltd. In Phase Ia, participants receive one of 3 to 4 escalating doses of SXRN Injection (4 mg, 6 mg, 8 mg, or another dose), given intravenously once daily for 5 days followed by a 2-day break, forming a 3-week treatment cycle. Phase Ib includes two dose levels (6 mg and 8 mg) combined with standard anti-tumor treatment. Participants are enrolled sequentially by dose levels. The study plans to enroll 12-24 patients in Phase Ia and 20-30 in Phase Ib and is conducted at 1-2 centers nationwide. Participants will undergo various assessments including blood tests, physical function tests, weight and body composition measurements, questionnaires on appetite and quality of life, and tumor evaluations. Researchers will monitor side effects, drug levels in the body, and treatment responses up to 12 months or longer. The primary outcomes include maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose. Secondary measures involve changes in appetite, physical function, body weight, survival, and tumor response. Participants will be followed closely during and after treatment.

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 skills—cognitive restructuring, opposite to emotion action, or mindfulness—that 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.

Researchers are studying anorexia nervosa (AN), a serious psychiatric disorder with the highest mortality rate, focusing on how caloric and non-caloric food intake affects stress responses and brain activity. The study compares female AN patients aged 13 to 18 who are newly diagnosed and treatment-nave, with healthy volunteers matched by age, sex, and education. The aim is to understand biological and psychological responses linked to eating in AN and to explore brain network changes related to calorie intake through neuroendocrine and psychological measures. Participants will be randomly assigned to consume one of two jellies: a 400-calorie mixture or a calorie-free mixture, both prepared to look and taste similar. AN patients will be admitted overnight to ensure a 12-hour fast before the study day. After psychiatric assessments and initial brain scans, participants will consume the jelly within 15 minutes, and their intake amount will be recorded. A second brain scan one hour later will assess brain network changes. Three hours later, participants will be offered a standard oatmeal meal with calories, allowed up to 500 kcal, and the amount consumed will also be measured. Throughout the study, participants will undergo psychiatric evaluations, blood sampling for hormones and biochemical markers, blood pressure and pulse monitoring, and brain MRI scans before and after meal intake. Self-report scales will assess hunger, anxiety, mood, and eating-related fears. Researchers will compare physiological, psychological, and behavioral responses before and after meals between AN patients who receive calories, those who do not, and matched healthy controls. The study will last until the end of 2026 with ongoing monitoring and data analysis.

Researchers are evaluating the effects of a dietary supplement on blood-based nutritional biomarkers in healthy children aged 4 to 15 years. This pilot clinical study aims to gather preliminary data on how the supplement influences serum levels of vitamin D, vitamin B12, folate, omega-3 fatty acids, and other blood count parameters. The study is conducted by SF Research Institute, Inc. and focuses on understanding nutritional status through biomarker changes. The study involves a single group of participants who will take an investigational gummy dietary supplement called Kids Multi & Omegas. Children will be instructed to take two gummies once daily, with or without food, for a total of 4 weeks. Blood samples will be collected at the start and end of the study to assess changes in selected serum nutritional biomarkers. Participants will also undergo measurements of height, weight, and body mass index, and complete a socioeconomic questionnaire. Participants will attend two clinic visits: one for screening and baseline assessments and another at the end of the 4-week supplementation period. During the study, children or their caregivers will keep a daily diary recording supplement intake, medication use, and any side effects. Researchers will review compliance, collect blood samples, and assess changes in nutritional biomarkers and physical measurements. The total study duration for each participant is approximately 4 weeks.

Researchers are exploring whether behavioral and psychological factors are linked to the types and functions of bacteria in the intestines of children and adolescents with eating disorders (ED). The study focuses on differences in gut microbiota between young patients with ED and healthy peers, dietary and lifestyle influences on gut bacteria, and whether these factors can predict treatment response after one year. It also examines gut microbiota differences among various ED subtypes including anorexia nervosa and avoidant/restrictive food intake disorder (ARFID). The study involves two groups: children and adolescents recently diagnosed with an eating disorder and healthy participants matched by age and sex. Participants with ED will complete lifestyle and psychological questionnaires, undergo body measurements, and provide blood and stool samples at the start and after one year. Healthy participants will provide similar data only at baseline. Stool samples will be analyzed for bacteria types and functions using advanced DNA sequencing techniques. Participants will share detailed medical, psychiatric, and lifestyle histories through interviews and questionnaires. Researchers will measure body composition, blood markers related to hormones and inflammation, and analyze stool for gut bacteria and metabolites. Psychological tests will assess eating disorder symptoms and related mental health conditions. The main outcomes measured are gut microbiota composition and function at baseline, with follow-up after one year for patients. The study aims to improve understanding of gut-related factors in eating disorders to support personalized treatment approaches.

Researchers are evaluating a single-session, online, parent-focused intervention aimed at preventing body image concerns and disordered eating in young children aged 2 to 6 years. This study addresses the early recognition of societal appearance ideals by children and the role of parents in shaping their children's exposure to these ideals. The study focuses on reducing predictors of body image disturbance, which are linked to serious mental health issues including eating disorders that have significant psychological and physical impacts. The intervention consists of a modular workshop delivered online to parents, covering four key areas: Body Image Development and Body Talk, Food Talk, Picky Eating and Mealtime Conversations, and Media Usage and Social Comparison. Each module lasts about 10 minutes. In the study, 50 parents will receive the full intervention while another 50 parents in the control group will not receive any intervention but will complete knowledge checks. The study aims to test the acceptability and feasibility of this approach. Participants will complete the intervention modules and then provide feedback on their experience, including which module they found most useful, along with knowledge assessments. Researchers will monitor acceptability immediately after the intervention and track recruitment, retention, and data completeness over approximately one year. The study will also evaluate the initial effectiveness of the intervention directly after completion. Participation involves completing online modules and questionnaires during the study period.

This research aims to evaluate the effect of adding an 8-week standardized Adapted Physical Activity (APA) program to usual care for people with anorexia nervosa. Anorexia nervosa patients often engage in excessive physical activity, which can interfere with nutrition and cause health complications. The study hypothesizes that including the APA program, which incorporates psychoeducation about problematic physical activity and healthy exercise habits, will improve treatment outcomes such as body mass index and overall health. Participants will be randomly assigned to one of two groups: one receiving the usual treatment for anorexia nervosa in day hospital or inpatient programs according to HAS guidelines, and the other receiving the same usual care plus the APA program. The APA involves eight weekly sessions of 1.5 hours each, focusing on adapted physical activity and psychoeducation to promote safe exercise practices. The program is designed to improve treatment adherence and reduce conflicts related to physical activity restrictions. During the study, participants will be assessed at the start and end of the 9-week program, as well as 6 months later. Evaluations will include body mass index changes, body composition by bioelectric impedance, physical activity levels, fitness perception, self-esteem, body shape perception, quality of life, symptoms of anxiety, depression, and eating disorders, and treatment dropout rates. These assessments involve questionnaires, physical tests, and monitoring of physical activity. The total participation includes the 8-week program plus follow-up assessments to observe lasting effects.