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Bulimia Nervosa is an eating disorder characterized by cycles of binge eating followed by compensatory behaviors. Clinical trials for Bulimia Nervosa often explore treatment evaluations, including cognitive-behavioral therapy and medication effects, ...

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Found 153 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 15Years - 18YearsAll GendersPhase Not Applicable
3 locations
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Actively Recruiting

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.

Age: 14Years +All Genders
1 location
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Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

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.

Age: 4Years - 15YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

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 avoidantrestrictive 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.

Age: 7Years - 18YearsAll Genders
2 locations
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Actively Recruiting

Eating disorders are affecting many adolescents, with up to 22% showing symptoms, often alongside other mental health issues. Since adolescence is a crucial time when eating disorders can begin, preventing them during this period is very important. This study aims to adapt and test a digital chatbot program designed to prevent eating disorders in diverse groups of adolescents, including underserved populations such as low-income youth and minorities. Participants in the study will use the Wysa digital chatbot program, which offers cognitive-behavioral therapy CBT based self-help modules focused on regular eating habits and improving body image. The program includes five modules delivered over three months. The study has two groups one receives immediate access to the chatbot, while the other group waits six months before accessing it after completing the study. Throughout the study, participants will engage with the chatbot daily to complete the modules. Researchers will assess eating disorder risk factors using tools like the Weight Concerns Scale at six months. The study also focuses on addressing depression and anxiety as related issues. The total participation duration covers the three months of program use plus follow-up assessments to evaluate the chatbots effectiveness in preventing eating disorders.

Age: 13Years - 19YearsAll GendersPhase 2
1 location
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Actively Recruiting

Researchers are evaluating the accuracy of low-cost self-completion questionnaires in identifying eating disorder symptoms compared to detailed clinical interviews and specialist assessments. The study focuses on adults referred to specialist eating disorder services, aiming to develop reliable tools for diagnosing common eating disorders like anorexia nervosa, bulimia nervosa, and binge-eating disorder. This research responds to the priority need for better measurement methods recognized by healthcare professionals, patients, and caregivers. Participants will complete the Schedules for Clinical Assessment in Neuropsychiatry version 3 section 9 SCANv3s9 semi-structured interview and two self-completion measures the Eating Disorder Examination Questionnaire Short-Form EDE-QS and the SCOFF questionnaire. The study includes an initial assessment phase with 100 adults and a retesting phase with 25 participants to check reliability. The SCAN items cover symptoms over the past 4 weeks and the preceding 11 months. During the study, participants will undergo interviews lasting 60 to 84 minutes and fill out questionnaires taking just a few minutes each. Researchers will compare findings from these tools to clinician diagnoses and analyze agreement levels, sensitivity, and specificity. A subset will repeat assessments to measure consistency. The study helps establish benchmarks for diagnosing eating disorders in clinical and community settings, with participation lasting as needed for initial and retest evaluations.

Age: 16Years +All Genders
1 location
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Actively Recruiting

Researchers are evaluating varenicline as a treatment for tobacco use disorder and nicotine craving in adults aged 22 and older who are daily tobacco cigarette users. This early phase 1 clinical trial aims to advance understanding of VR-based attentional bias as a biomarker for tobacco use disorder by comparing varenicline to placebo in a randomized, quadruple-blind study. Participants will be randomly assigned to receive either varenicline or a matched placebo. Those in the varenicline group will undergo an 8-day dose escalation starting at 0.5 mg once daily, increasing to a target dose of 1 mg twice daily by Day 8. Both groups will have assessments using a virtual reality nicotine cue exposure task at baseline and after reaching the target dose. Following in-person testing on Day 9 or up to Day 11 if needed, participants continue their assigned dosing for eight more days while being monitored remotely via mobile assessments. During the study, participants will complete virtual reality tests measuring attentional bias to nicotine cues and report nicotine craving and use episodes at baseline and after treatment. Mobile assessments will track nicotine use behaviors for eight days at the target dose and by phone 30 days later. The primary outcomes include changes in VR attentional bias, nicotine craving, and nicotine use episodes over the study period. Participants are expected to be available for the full duration of the trial to complete all procedures and follow-up assessments.

Age: 22Years +All GendersEarly Phase 1
1 location
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Actively Recruiting

Healthy Volunteer

Eating disorders, including Anorexia Nervosa and Bulimia Nervosa, affect how individuals relate to food and body image. Researchers are studying new treatments using virtual reality VR combined with artificial intelligence AI to provide personalized therapy systems. These advanced approaches aim to improve diagnosis and treatment effectiveness by monitoring severity, risks, and responses to therapy more accurately than traditional cognitive behavioral therapy CBT. The study includes four groups two intervention groups using VR and AI technologies tailored for Anorexia Nervosa Enhanced Body-Swap and Bulimia Nervosa Emotional Rescripting, and two control groups receiving standard CBT without VR or AI. The Anorexia treatment involves 12 bi-weekly VR sessions where participants embody virtual avatars with gradually adjusted body mass index. The Bulimia treatment includes assessment, evaluation with biosensors, and 9 VR sessions focused on emotional regulation. Control groups follow similar therapy schedules without VR or AI. Participants undergo baseline assessments and follow-up evaluations at 4, 8, and 12 weeks using various scales measuring eating disorder symptoms, body image, anxiety, emotional regulation, and food craving. The study uses questionnaires and biosensors to monitor progress and therapy effects. Total participation includes treatment sessions and multiple follow-up assessments to evaluate the long-term impact of the interventions.

Age: 15Years - 40YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are studying the brain areas involved in avoidance learning in adult women aged 18 to 39 with eating disorders, specifically anorexia nervosa and bulimia nervosa, compared to healthy women. They aim to understand behavioral differences in avoidance learning, brain activity changes measured by functional magnetic resonance imaging fMRI, and differences in brain connectivity related to these disorders. The study includes 78 women with eating disorders and 26 healthy controls. Participants are grouped based on diagnostic criteria for anorexia nervosa, bulimia nervosa, or no eating disorder. The study uses brain imaging techniques like fMRI, computer tasks to assess learning behaviors, and self-report questionnaires and interviews. Brain responses to avoidance learning and connectivity are measured during sessions lasting 10 to 25 minutes. During the study, participants complete behavioral tasks, undergo fMRI scans to monitor brain activity and connectivity, and provide information through questionnaires and interviews. Researchers will measure learning rates, brain responses, and functional connectivity related to avoidance learning. The study monitors participants health and eligibility carefully, including weight and medication use, over the study period which starts in August 2024 and continues through July 2027.

Age: 18Years - 39YearsFEMALE
1 location

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